Randomized, Double-blind, Crossover Trial Assessing the Efficacy of Indapamide and Chlorthalidone Compared to Hydrochlorothiazide for the Reduction of Urine Supersaturation for Kidney Stone Prevention

The aim of this study is to test the efficacy of the two long-acting thiazide-like diuretics indapamide and chlorthalidone in reducing urine supersaturation for calcium oxalate and calcium phosphate compared to the short-acting thiazide diuretic hydrochlorothiazide for the prevention of calcium-containing kidney stones.

Start Date01 Oct 2024

Sponsor / Collaborator

Insel Gruppe AG

[+1]

IRCT20210519051345N65 / RecruitingIIT

In vivo bioequivalence study of Indapamide 1.5 mg tablet manufactured by Pars Darou Co. compared with innovator product

Start Date20 Aug 2024

Sponsor / Collaborator

Tabriz University of Medical Sciences

CTIS2024-510835-23-00 / Not yet recruiting

- 204-PKT-202301

Start Date19 Jun 2024

Sponsor / Collaborator

PRO.MED.CS Praha as

100 Clinical Results associated with Indapamide

100 Translational Medicine associated with Indapamide

100 Patents (Medical) associated with Indapamide

1,422

Literatures (Medical) associated with Indapamide

01 Dec 2024·JOURNAL OF HYPERTENSION

Combination blood pressure lowering therapy in patients with type 2 diabetes: messages from the ADVANCE trial

Review

Author: Hamet, Pavel ; Poulter, Neil ; Mancia, Giuseppe ; Wang, Nelson ; Chalmers, John ; Harrap, Stephen ; Grobbee, Diederick E. ; Harris, Katie ; Marre, Michel ; Woodward, Mark

The Action in Diabetes and Vascular disease: preterAx and diamicroN Controlled Evaluation (ADVANCE) trial investigated the effects of intensive blood pressure (BP) lowering using a fixed combination of perindopril-indapamide versus placebo in type 2 diabetes (T2D). The study showed that combination perindopril-indapamide had significant benefits in reducing cardiovascular, renal, and mortality events, with consistent relative risk reductions across different patient subgroups. Secondary analyses of ADVANCE have identified novel risk markers in T2D including cessation of BP lowering therapy, absent peripheral pulses and cardiac biomarkers to name a few. ADVANCE also shed light on practical aspects of hypertension management, including the limitations of office BP, tolerability of combination BP lowering therapy across the range of BP levels and the interpretation of changes in serum creatinine after treatment initiation. This review article summarizes the findings of ADVANCE and its subsequent substudies, which have been foundational in our understanding of BP management and the use of combination BP lowering therapy in T2D.

01 Oct 2024·JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Low-Dose Triple-Pill vs Standard-Care Protocols for Hypertension Treatment in Nigeria

Article

Author: Salam, Abdul ; Ripiye, Nanna. R. ; Huffman, Mark D. ; Rodgers, Anthony ; Orimolade, Olanike Allison ; Sani, Mahmoud U. ; Abdussalam, Tijjani ; Pant, Rashmi ; Alfa, Isiaka M. ; Ogah, Okechukwu S. ; Ghosh, Arpita ; Dhurjati, Rupasvi ; Schutte, Aletta E. ; Lakshmi, Josyula K. ; Olawumi, Abdulgafar L. ; Ojji, Dike B. ; Kana, Shehu A. ; Ajayi, Moses O. ; Orji, Ikechukwu A.

Importance:

With the high burden of hypertension in sub-Saharan Africa, there is a need for effective, safe and scalable treatment strategies.

Objective:

To compare, among Black African adults, the effectiveness and safety of a novel low-dose triple-pill protocol compared with a standard-care protocol for blood pressure lowering.

Design and Setting:

Randomized, parallel-group, open-label, multicenter trial conducted in public hospital–based family medicine clinics in Nigeria.

Participants:

Black African adults with uncontrolled hypertension (≥140/90 mm Hg) who were untreated or receiving a single blood pressure–lowering drug.

Interventions:

Participants were randomly allocated to low-dose triple-pill or standard-care protocols. The triple-pill protocol involved a novel combination of telmisartan, amlodipine, and indapamide in triple one-quarter, one-half, and standard doses (ie, 10/1.25/0.625 mg, 20/2.5/1.25 mg, and 40/5/2.5 mg), with accelerated up-titration. The standard-care protocol was the Nigeria hypertension treatment protocol starting with amlodipine (5 mg).

Main Outcomes and Measures:

The primary effectiveness outcome was the reduction in home mean systolic blood pressure, and the primary safety outcome was discontinuation of trial treatment due to adverse events, both from randomization to month 6.

Results:

The first participant was randomized on July 19, 2022, and the last follow-up visit was on July 18, 2024. Among 300 randomized participants (54% female; mean age, 52 years; baseline mean home blood pressure, 151/97 mm Hg; and clinic blood pressure, 156/97 mm Hg), 273 (91%) completed the trial. At month 6, mean home systolic blood pressure was on average 31 mm Hg (95% CI, 28 to 33 mm Hg) lower in the triple-pill protocol group and 26 mm Hg (95% CI, 22 to 28 mm Hg) lower in the standard-care protocol group (adjusted difference, −5.8 mm Hg [95% CI, −8.0 to −3.6]; P &lt; .001]). At month 6, clinic blood pressure control (&lt;140/90 mm Hg) was 82% vs 72% (risk difference, 10% [95% CI, −2% to 20%]) and home blood pressure control (&lt;130/80 mm Hg) was 62% vs 28% (risk difference, 33% [95% CI, 22% to 44%]) in the triple-pill compared with the standard-care protocol group; these were 2 of 21 prespecified secondary effectiveness end points. No participants discontinued trial treatment due to adverse events.

Conclusions and Relevance:

Among Black African adults with uncontrolled hypertension, a low-dose triple-pill protocol achieved better blood pressure lowering and control with good tolerability compared with the standard-care protocol.

Trial Registration:

Pan African Clinical Trials Registry Identifier: PACTR202107579572114

01 Oct 2024·LANCET

Efficacy and safety of a novel low-dose triple single-pill combination of telmisartan, amlodipine and indapamide, compared with dual combinations for treatment of hypertension: a randomised, double-blind, active-controlled, international clinical trial

Article

Author: Salam, Abdul ; Spiering, Wilko ; Hay, P ; Schutte, Aletta E ; Wang, Nelson ; Uluwattage, W ; Williams, Bryan ; Ojji, Dike B ; Lakshman, P ; Gnanenthiran, Sonali R ; Gianacas, Chris ; de Silva, H Asita ; Wright, Jackson T ; Narkiewicz, Krzysztof ; Liu, Xiaoqiu ; Ranasinghe, G ; Shanthakumar, Mathangi ; Cushman, William C ; Schlaich, Markus P ; Poulter, Neil R ; Pereira, T ; Di Tanna, Gian Luca ; Grobbee, Diederick E ; Amarasena, N ; Rodgers, Anthony ; Oparil, Suzanne ; Whelton, Paul K

BACKGROUND:

Single-pill combinations (SPCs) of three low-dose antihypertensive drugs can improve hypertension control but are not widely available. A key issue for any combination product is the contribution of each component to efficacy and tolerability. This trial compared a new triple SPC called GMRx2, containing telmisartan, amlodipine, and indapamide, with dual combinations of components for efficacy and safety.

METHODS:

In this international, randomised, double-blind, active-controlled trial, we enrolled adults with hypertension receiving between zero and three antihypertensive drugs, with a screening systolic blood pressure (SBP) ranging from 140-179 mm Hg (on no drugs) to 110-150 mm Hg (on three drugs). Participants were recruited from Australia, the Czech Republic, New Zealand, Poland, Sri Lanka, the UK, and the USA. In a 4-week active run-in, existing medications were switched to GMRx2 half dose (telmisartan 20 mg, amlodipine 2·5 mg, and indapamide 1·25 mg). Participants were then randomly allocated (2:1:1:1) to continued GMRx2 half dose or to each possible dual combination of components at half doses (telmisartan 20 mg with amlodipine 2·5 mg, telmisartan 20 mg with indapamide 1·25 mg, or amlodipine 2·5 mg with indapamide 1·25 mg). At week 6, doses were doubled in all groups, unless there was a clinical contraindication. The primary efficacy outcome was mean change in home SBP from baseline to week 12, and the primary safety outcome was withdrawal of treatment due to an adverse event from baseline to week 12. Secondary efficacy outcomes included differences in clinic and home blood pressure levels and control rates. This study is registered with ClinicalTrials.gov, NCT04518293, and is completed.

FINDINGS:

The trial was conducted between July 9, 2021 and Sept 1, 2023. We randomly allocated 1385 participants to four groups: 551 to GMRx2, 276 to telmisartan-indapamide, 282 to telmisartan-amlodipine, and 276 to amlodipine-indapamide groups. The mean age was 59 years (SD 11), 712 (51%) participants self-reported as female and 673 (48·6%) male, and the mean clinic blood pressure at the screening visit was 142/85 mm Hg when taking an average of 1·6 blood pressure medications. Following the run-in on GMRx2 half dose, the mean clinic blood pressure level at randomisation was 133/81 mm Hg and the mean home blood pressure level was 129/78 mm Hg. At week 12, the mean home SBP was 126 mm Hg in the GMRx2 group, which was lower than for each of the dual combinations: -2·5 (95% CI -3·7 to -1·3, p<0·0001) versus telmisartan-indapamide, -5·4 (-6·8 to -4·1, p<0·0001) versus telmisartan-amlodipine, and -4·4 (-5·8 to -3·1, p<0·0001) versus amlodipine-indapamide. For the same comparisons, differences in clinic blood pressure at week 12 were 4·3/3·5 mm Hg, 5·6/3·7 mm Hg, and 6·3/4·5 mm Hg (all p<0·001). Clinic blood pressure control rate below 140/90 mm Hg at week 12 was superior with GMRx2 (74%) to with each dual combination (range 53-61%). Withdrawal of treatment due to adverse events occurred in 11 (2%) participants in the GMRx2 group, four (1%) in telmisartan-indapamide, three (1%) in telmisartan-amlodipine, and four (1%) in amlodipine-indapamide, with none of the differences being statistically significant.

INTERPRETATION:

A novel low-dose SPC product of telmisartan, amlodipine, and indapamide provided clinically meaningful improvements in blood pressure reduction compared with dual combinations and was well tolerated. This SPC provides a new therapeutic option for the management of hypertension and its use could result in a substantial improvement in blood pressure control in clinical practice.

FUNDING:

George Medicines.

News (Medical) associated with Indapamide

18 Oct 2024

·www.globenewswire.com

Phase III trial results of novel triple combination pill for hypertension published in The Lancet

Phase III trial results of novel triple combination pill for hypertension published in The Lancet Novel combination pill significantly reduced blood pressure and improved control rates vs dual therapy, with good tolerability and no increase in adverse event related withdrawalsTriple combination approach aligns with latest European Society of Cardiology hypertension guidelines recommending increased use of combination therapies Subject to regulatory review, following New Drug Application (NDA) filed with FDA in August, GMRx2 would be the first triple combination approved for initial treatment of hypertension London, UK, 18 October 2024 – George Medicines, a late-stage biopharmaceutical company focused on addressing significant unmet needs in cardiometabolic disease treatment, today announced that The Lancet has published results from its pivotal Phase III clinical trial of GMRx2. A proprietary combination of three best-in-class medicines, telmisartan, amlodipine and indapamide, developed in an ultra-low dose (triple quarter-dose), low-dose (triple half-dose), and triple standard-dose options, GMRx2 was compared with dual combinations, for the treatment of hypertension (high blood pressure), including initiation of treatment. The triple combination’s multi-mechanism approach is designed to deliver optimal efficacy and safety while promoting patient adherence. The research, “Efficacy and safety of a novel low-dose triple single-pill combination of telmisartan, amlodipine and indapamide, compared with dual combinations for treatment of hypertension: a randomised, double-blind, active-controlled, international clinical trial”, is published in the 19 October issue of The Lancet. The international trial, conducted in seven countries, met all primary efficacy and safety endpoints: GMRx2 was more effective than each dual therapy, significantly reducing both home- and clinic-measured blood pressure (BP) and improving BP control rates, with both standard- and half-dose forms.GMRx2 half-dose achieved 63% clinic BP control <140/90 mmHg, which rose to 74% at the end of follow-up on GMRx2 standard-dose – superior to all three dual combinations at standard-dose (53-61%).Assessed against more stringent BP control rates of <130/80 mmHg, GMRx2 standard dose achieved 56% control rates, again clinically and statistically superior to all three dual combinations (33-44%).Tolerability was good, with no increase in withdrawal from treatment due to adverse events. This treatment approach aligns with recently updated European Society of Cardiology (ESC) guidelines for hypertension management1, which recommend lower blood pressure levels to begin treatment among those at raised risk and greater use of combination therapy, starting off with dual low-dose followed by a triple low -dose therapy. Chair of the trial’s steering committee, Dr. Paul Whelton, Show Chwan Chair of Global Public Health at Tulane University, New Orleans, Louisiana, and President of the World Hypertension League, commented: “This trial, conducted across seven countries and diverse populations, demonstrates that GMRx2 provides significantly better blood pressure control compared to dual combinations, while maintaining an excellent safety profile. The findings are particularly noteworthy as they show efficacy at lower blood pressure levels, aligning with the latest guideline recommendations. This new single-pill combination has the potential to address the critical need for more effective and tolerable treatment options to achieve and maintain blood pressure control in the many patients who remain uncontrolled on current therapies.” Dr. Anthony Rodgers, Chief Medical Officer of George Medicines, and Professorial Fellow at The George Institute for Global Health, said: “These findings, now published in The Lancet, provide robust evidence for the potential of GMRx2 to transform hypertension management. The superior efficacy of this triple combination therapy compared to dual combinations, coupled with its good tolerability, addresses key challenges in current hypertension treatment approaches and directly supports recent guideline recommendations. Subject to regulatory approval, we believe GMRx2 could play a crucial role in addressing the global burden of hypertension and improving patient outcomes.” These results, along with data from other recent trials, including the VERONICA trial in Nigeria, funded by the National Health and Medical Research Council (NHMRC) of Australia, supported by The George Institute for Global Health and recently published in JAMA, and a placebo-controlled Phase III study recently published in the Journal of the American College of Cardiology, provide a comprehensive body of evidence supporting the efficacy and safety of GMRx2 across various patient populations and dosing regimens. In August 2024 George Medicines announced its submission to the US Food and Drug Administration (FDA) of a New Drug Application (NDA) for GMRx2. Data from GMRx2’s clinical development program will support additional global regulatory filings. George Medicines is an independent spin-out company from The George Institute for Global Health, one of the world’s leading medical research institutes with a focus on addressing global health inequity. The Company is backed by George Health, the commercial arm of The George Institute, and Brandon Capital, Australia’s leading life sciences venture capital firm. The Company’s GMRx2 development program built on earlier research by The George Institute, including the 700-patient TRIUMPH trial undertaken in Sri Lanka in 2016/17, which found that among patients with mild to moderate hypertension, treatment with a low-dose triple combination pill led to an increased proportion of patients achieving their target blood pressure goal versus usual care. Ends About the clinical trialA Phase III trial among 1,385 patients in Australia, Czech Republic, New Zealand, Poland, Sri Lanka, UK and the US, standard- and half-dose forms of GMRx2 were tested against dual combinations of its component drugs. The trial’s primary efficacy outcome was the difference between GMRx2 and its comparators in home blood pressure change from randomization to week 12. The head-to-head trial provides the first large scale comparison of a low- and standard-dose triple combination pill and its dual combinations at the same doses. It assessed the safety and efficacy of the triple combination among patients with starting blood pressure levels that were considerably lower than those in previous trials. About hypertension (high blood pressure)Globally, more than one billion adults have hypertension2. Many diagnosed patients aren’t achieving sufficient blood pressure control because they are on inadequate therapy, aren’t receiving the right combination of medicines at the right doses or aren’t taking their treatment as prescribed or continuing their treatment in the long term. The major, globally recognized treatment guidelines3 recommend the use of fixed dose combination therapy for most patients with hypertension, including for first-line treatment and yet, in practice, newly diagnosed patients will often still be prescribed monotherapy treatment. This is despite a broad evidence base indicating that, individually, blood pressure medicines are only modestly effective at reducing blood pressure, even at high doses, and most patients will require two or more medicines to achieve control. As dosage of hypertension drugs is increased, so too are side effects, which can preclude the use of high doses for many patients. These side effect challenges, alongside the management of multiple hypertension medicines being taken together with treatments for other conditions, can significantly impact treatment compliance and adherence, including failure to take medications as prescribed and to persist on long-term therapy. About George Medicines George Medicines is a late-stage biopharmaceutical company addressing significant unmet need in the treatment of cardiometabolic diseases with innovative combinations of best-in-class existing treatments, designed for optimal efficacy and safety. Combining best-in-class molecules from existing medicines in novel low-dose formulations, George Medicines is developing innovative and proprietary treatments to be more efficacious, safer and accessible than currently available treatment options. These multi-mechanism, single-pill combinations offer the potential to bring significant improvements in clinical outcomes and therapy adherence in patients with cardiometabolic disorders, including hypertension and diabetes, each of which remain the leading causes of premature death and disability worldwide. The Company’s lead candidate, GMRx2, has completed a Phase III development program for the treatment of hypertension, including first-line therapy, and a global trial focused on the prevention of recurrent intracerebral hemorrhage (the most severe type of stroke) is underway. George Medicines is an independent spin-out company from The George Institute for Global Health, one of the world’s leading medical research institutes with a focus on addressing global health inequity. The Company is backed by George Health, the commercial arm of The George Institute, and Brandon Capital, Australia’s leading life sciences venture capital firm. For more information, please visit www.george-medicines.com. References 2024 ESC Guidelines for the management of elevated blood pressure and hypertension https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/Elevated-Blood-Pressure-and-HypertensionWorld Health Organization Hypertension factsheet https://www.who.int/news-room/fact-sheets/detail/hypertension2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines https://www.ahajournals.org/doi/10.1161/HYP.0000000000000065; WHO Guideline for the pharmacological treatment of hypertension in adults https://iris.who.int/bitstream/handle/10665/344424/9789240033986-eng.pdf; 2024 ESC Guidelines for the management of elevated blood pressure and hypertension https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/Elevated-Blood-Pressure-and-Hypertension Media contacts ICR Consilium David Daley, Lindsey Neville, Isabelle Abdou georgemedicines@consilium-comms.com; Tel: +44 (0) 203 709 5700

Phase 3Clinical ResultNDA

24 Sep 2024

·www.globenewswire.com

Potential of George Medicines’ novel, low-dose, triple combination pill to transform management of hypertension highlighted at global congress

London, UK 24 September 2024 – George Medicines, a late-stage, biopharmaceutical company addressing significant unmet need in the treatment of cardiometabolic disease, today announced the presentation of positive clinical trial results investigating GMRx2, its novel, multi-mechanism triple combination candidate for the treatment of hypertension, including initiation of treatment, at the recent 30th Congress of the International Society of Hypertension, held in Cartagena, Colombia, 19-22 September. GMRx2 contains best-in-class medicines, telmisartan, amlodipine and indapamide, in proprietary, triple quarter-dose (ultra-low dose), triple half-dose (low-dose) and triple standard-dose options. Designed for optimal efficacy, safety and adherence, GMRx2’s low-dose, multi-mechanism approach, delivers the synergistic efficacy benefits of a triple therapy while maintaining tolerability. Professor Paul Whelton, Show Chwan Chair of Global Public Health at Tulane University, New Orleans, Louisiana, President of the World Hypertension League and Chair of the steering committee for the Phase III clinical trial program shared an overview of recent positive clinical data from three recent trials: George Medicines’ pivotal Phase III trial testing GMRx2 against dual combinations of its component drugs, which determined that GMRx2 was more effective than dual therapy, significantly reducing blood pressure (BP) and improving BP control rates, with both standard- and half-dose forms.A second Phase III trial, recently published in the Journal of the American College of Cardiology, comparing GMRx2 against a placebo pill, in which GMRx2 significantly improved BP and BP control rates, in both half- and quarter-doses.The VERONICA trial in Nigeria, led by Professor Dike Ojji at University of Abuja, funded by the National Health and Medical Research Council (NHMRC) of Australia, supported by The George Institute for Global Health and recently published in JAMA, which compared GMRx2-based treatment protocol with existing, standard care protocol and reported significant reductions in BP among those receiving GMRx2. In all trials, tolerability was good, with no increase in withdrawal from treatment due to adverse events. Mark Mallon, Chief Executive Officer of George Medicines, said: “We’re pleased that the clinical and global health significance of our research findings for GMRx2 are being shared with the international hypertension community. The continuing disease burden of hypertension is too big to ignore and with GMRx2 we have an opportunity to unlock better treatment for patients globally.” In August 2024 George Medicines announced its submission to the US Food and Drug Administration (FDA) of a New Drug Application (NDA) for GMRx2. Data from GMRx2’s clinical development program will support additional global regulatory filings. George Medicines is an independent spin-out company from The George Institute for Global Health, one of the world’s leading medical research institutes with a focus on addressing global health inequity. The Company’s GMRx2 development program built on earlier research by The George Institute, including the 700-patient TRIUMPH trial undertaken in Sri Lanka in 2016/17, which found that among patients with mild to moderate hypertension, treatment with a low-dose triple combination pill led to an increased proportion of patients achieving their target blood pressure goal versus usual care. Ends About hypertension (high blood pressure)Globally, more than one billion adults have hypertension1. Many diagnosed patients aren’t achieving sufficient blood pressure control because they are on inadequate therapy, aren’t receiving the right combination of medicines at the right doses or aren’t taking their treatment as prescribed or continuing their treatment in the long term. The major, globally recognized treatment guidelines4 recommend the use of fixed dose combination therapy for most patients with hypertension, including for first-line treatment and yet, in practice, newly diagnosed patients will often still be prescribed monotherapy treatment. This is despite a broad evidence base indicating that, individually, blood pressure medicines are only modestly effective at reducing blood pressure, even at high doses, and most patients will require two or more medicines to achieve control. As dosage of hypertension drugs is increased, so too are side effects, which can preclude the use of high doses for many patients. These side effect challenges, alongside the management of multiple hypertension medicines being taken together with treatments for other conditions, can significantly impact treatment compliance and adherence, including failure to take medications as prescribed and to persist on long-term therapy. About George Medicines George Medicines is a late-stage biopharmaceutical company addressing significant unmet need in the treatment of cardiometabolic diseases with innovative combinations of best-in-class existing treatments, designed for optimal efficacy and safety. Combining best-in-class molecules from existing medicines in novel low-dose formulations, George Medicines is developing innovative and proprietary treatments to be more efficacious, safer and accessible than currently available treatment options. These multi-mechanism, single-pill combinations offer the potential to bring significant improvements in clinical outcomes and therapy adherence in patients with cardiometabolic disorders, including hypertension and diabetes, each of which remain the leading causes of premature death and disability worldwide. The Company’s lead candidate, GMRx2, has completed a Phase III development program for the treatment of hypertension, including first-line therapy, and a global trial focused on the prevention of recurrent intracerebral hemorrhage (the most severe type of stroke) is underway. George Medicines is an independent spin-out company from The George Institute for Global Health, one of the world’s leading medical research institutes with a focus on addressing global health inequity. The Company is backed by George Health, the commercial arm of The George Institute, and Brandon Capital, Australia’s leading life sciences venture capital firm. For more information, please visit www.george-medicines.com. References World Health Organization Hypertension factsheet https://www.who.int/news-room/fact-sheets/detail/hypertension2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines https://www.ahajournals.org/doi/10.1161/HYP.0000000000000065; WHO Guideline for the pharmacological treatment of hypertension in adults https://iris.who.int/bitstream/handle/10665/344424/9789240033986-eng.pdf; 2024 ESC Guidelines for the management of elevated blood pressure and hypertension https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/Elevated-Blood-Pressure-and-Hypertension Media contacts ICR Consilium David Daley, Lindsey Neville, Isabelle Abdou georgemedicines@consilium-comms.com; Tel: +44 (0) 203 709 5700

Phase 3NDAClinical Result

11 Sep 2024

·www.drugs.com

Quadruple Single Pill Superior for Resistant Hypertension

WEDNESDAY, Sept. 11, 2024 -- For patients with resistant hypertension , a quadruple single pill is superior to triple therapy, according to a study presented at the European Society of Cardiology Congress, held from Aug. 30 to Sept. 2 in London. Stefano Taddei, from the University of Pisa in Italy, and colleagues conducted a double-blind, randomized trial involving patients with resistant hypertension. Participants completed an eight-week run-in period during which they received the triple combination of perindopril, indapamide, and amlodipine. Those with uncontrolled blood pressure (BP) after eight weeks while adherent to therapy were randomly allocated to continue the same triple therapy or receive a single-pill combination containing perindopril, indapamide, amlodipine, and bisoprolol. A total of 183 patients from 49 centers in 13 countries were included in the trial. The researchers found that the mean office sitting systolic BP was reduced by 20.67 and 11.32 mm Hg in the quadruple single-pill group and in the triple group, respectively, after eight weeks, with the adjusted difference significant in favor of the quadruple single pill. For the main secondary end point of mean 24-hour ambulatory systolic BP, there was a significant difference for the quadruple single pill versus the triple group (−7.53 mm Hg); in addition, there was a significant difference in favor of the quadruple single-pill group in mean office sitting diastolic BP (−6.14 mm Hg). BP control was achieved by 66.3 and 42.7 percent on the quadruple single pill and on triple therapy, respectively. "The availability of a quadruple single-pill combination that includes bisoprolol could help with non-adherence and provide much-needed effective BP control in patients with resistant or difficult-to-treat hypertension," Taddei said in a statement. Several authors disclosed ties to the pharmaceutical and medical device industry, including Servier, which funded the study. Press Release More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultClinical Study

100 Deals associated with Indapamide

External Link

KEGG	Wiki	ATC	Drug Bank
D00345	Indapamide	C03BA11	DB00808

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Essential Hypertension	JP	Kyoto Pharmaceutical Industries Ltd.	23 Oct 1984
Hypertension	US	Sanofi-Aventis U.S. LLC	06 Jul 1983

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ISN WCN2024	Not Applicable	Hyponatremia \| Hypovolemia	-	Indapamide 2.5 mg/d	odekjqdcsf(droecujttz) = knxanmtxjp xwqrjqinln (hmqiwushjx ) View more	-	01 Apr 2024
				Fludrocortisone 200 mcg	nhudcdkuiz(axhzenyogc) = jllperstlp axuaxbxrkr (hoeerizqck )
ESC2023	Phase 3	Essential Hypertension	532	Perindopril arginine 5 mg/Indapamide 1.25 mg/Amlodipine 5 mg (P5/I1.25/A5)	foozorbmvo(kjpkykmrum) = tvbetmmzqe lmhxiguxot (jkztwgwdgp ) View more	Positive	27 Aug 2023
				Perindopril tert-butylamine 4 mg/Indapamide 1.25 mg (P4/I1.25) plus Amlodipine 5 mg (P4/I1.25 +A5)	thjhwtrrsu(leqloxyqfc) = ntlzgtfade mudgpaxicy (pvsealbcsb ) View more
NCT03058783 (CTgov)	Phase 3	Dermatitis, Atopic	328	IDP-124 Lotion (IDP-124 Lotion)	fotloawgsw(outcduxaxs) = zdsrfzplqy whbhtektvg (uyqnnfgbob, ssyyswhgzx - eiqothkipu) View more	-	08 May 2023
				IDP-124 Vehicle Lotion (IDP-124 Vehicle Lotion)	fotloawgsw(outcduxaxs) = rkdprqopkk whbhtektvg (uyqnnfgbob, scxgilukxf - krpodzdtkd) View more
NCT03002571 (CTgov)	Phase 3	Dermatitis, Atopic	338	IDP-124 Lotion (IDP-124 Lotion)	hpekllfkun(lkrwmqxhtv) = vyrfbyjtfe lsxslkpovk (pliiplwqmb, gqflmrfqkv - wimcxwtgea) View more	-	08 May 2023
				IDP-124 Vehicle Lotion (IDP-124 Vehicle Lotion)	hpekllfkun(lkrwmqxhtv) = nhufqfquaj lsxslkpovk (pliiplwqmb, fovapeootn - icrlyoiqol) View more
NCT03664739 (CTgov)	Phase 3	Acne Vulgaris	608	IDP-120 Gel (IDP-120 Gel)	fuaftmzjzr(kopxzfazxy) = vpsxkjqfzt sxidniirni (ygjmfwncyw, lvhxvgdnng - usnsixeawd) View more	-	29 Mar 2023
				IDp-120 Vehicle Gel (IDP-120 Vehicle Gel)	fuaftmzjzr(kopxzfazxy) = xdcwxxlers sxidniirni (ygjmfwncyw, skumvhpibh - ihufdzqmrc) View more
NCT03664752 (CTgov)	Phase 3	Acne Vulgaris	585	IDP-120 Gel (IDP-120 Gel)	dlfmuynhsx(jicfjbobrc) = wxvcxuqiig fqqcagwxcp (emezowpyry, mcypxkeghx - acxuxxojxw) View more	-	29 Mar 2023
				IDP-120 Vehicle Gel (IDP-120 Vehicle Gel)	dlfmuynhsx(jicfjbobrc) = jhxmyfqplw fqqcagwxcp (emezowpyry, hrszdcdwqg - ibiezkrmtq) View more
ESC2022	Not Applicable	Hypertension Second line	-	Perindopril/amlodipine+indapamide	nwzopfzglq(ztzczwwggv) = 11 adverse reactions sisuwaygtu (jluqmjvmxy )	-	07 Apr 2022
NCT03168334 (CTgov)	Phase 3	Acne Vulgaris	801	IDP-123 Lotion	eqtpjhvmla(msjrezapqn) = pplpwvlsnj yydraonfed (ecyrmgefme, spcxqialbe - ppuzfmxngj) View more	-	01 Apr 2021
ISRCTN67799751 (Pubmed \| Adv Ther)	Not Applicable	Hypertension	22	Perindopril arginine/indapamide single-pill combination (Pa/I SPC)	uysecgmshv(ywsqkufnuo) = ljwzergkua ugzgnhomdp (xoxywwsotz ) View more	-	01 Dec 2020
NCT02462070 (CTgov)	Phase 3	Plaque psoriasis	203	IDP-118 Lotion (IDP-118 Lotion)	uczhetweif(acfwasiyzj) = yhlhvokven xfewhemnme (evaztjoqlm, cncquwiald - azoozcsoxy) View more	-	20 Aug 2020
				IDP-118 Vehicle Lotion (IDP-118 Vehicle Lotion)	uczhetweif(acfwasiyzj) = yboypczpnz xfewhemnme (evaztjoqlm, bkvouvzaaf - tmczshwovw) View more

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