FAN Trial: A randomised controlled open label trial assessing the effect of perindopril erbumine on Fontan-Associated Nephropathy in adults and children 5 years or older.

Start Date01 Jun 2024

Sponsor / Collaborator-

NCT06341101 / RecruitingPhase 4

Timely Recovery After Subclinical Heart Failure (TREASURE Trial)

The goal of this randomized controlled trial is to assess the effectiveness of ACE inhibitors versus standard care) in reversing asymptomatic heart failure (HF stage-B) and/or diastolic dysfunction during a two-year open-label treatment period for formerly preeclamptic women on:
Reversibility of structural and functional myocardial impairment in asymptomatic HF towards healthy values;
The progression from asymptomatic to symptomatic HF (symptoms scored based on the NYHA criteria);
Cardiovascular performance (volume- and pressure load), cardio metabolic risk factors (glucose metabolism, lipid status, kidney function) and quality of life (questionnaires);
Novel biomarkers and relevant microRNA's indicative for hypertrophy, fibrosis inflammation and ischemia.
Eligible subjects will be counselled and upon informed consent randomized for either medication group (n=65) or care as usual group (n=65). After a complete cardiovascular assessment, medication will be initiated open-labeled (Perindopril 2 mg or no medication). Thereafter, standard medical check-ups (blood pressure, ECG, kidney function, transthoracic cardiac ultrasound, endothelial function, quality of life questionnaires, medical history taking, blood and urine banking) will be performed every six months for two years.
Researchers will compare ACE inhibitor (Perindopril 2 mg) and care as usual (i.e. no medication) to investigate whether ACE inhibitor allows timely recovery after subclinical heart failure.

Start Date26 Mar 2024

Sponsor / Collaborator

Academisch Ziekenhuis Maastricht

[+1]

NCT06213610 / RecruitingPhase 1

Open-label Randomized Crossover Two Period Single Dose Bioequivalence Study of Two Formulations of Perindopril (Perindopril Tert-butylamine) 8 mg (Pharmtechnology LLC, Republic of Belarus) and Prestarium® A 10 mg (Perindopril Arginine) 10 mg Tablets (Les Laboratoires Servier Industrie, France) in Healthy Volunteers Under Fasting Conditions

This is an open-labeled, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Prestarium ® A 10 mg tablets) or the test (Perindopril 8 mg tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.

Start Date09 Jan 2024

Sponsor / Collaborator

Pharmtechnology, LLC

100 Clinical Results associated with Perindopril Erbumine

100 Translational Medicine associated with Perindopril Erbumine

100 Patents (Medical) associated with Perindopril Erbumine

2,114

Literatures (Medical) associated with Perindopril Erbumine

01 Mar 2024·European journal of pharmacology

Chymase-independent vascular Ang-(1–12)/Ang II pathway and TXA2 generation are involved in endothelial dysfunction in the murine model of heart failure

Article

Author: Garcia-Redondo, Ana B ; Mohaissen, Tasnim ; Buczek, Elzbieta ; Wojnar-Lason, Kamila ; Bar, Anna ; Briones, Ana M ; Kij, Agnieszka ; Marczyk, Brygida ; Chlopicki, Stefan ; Karas, Agnieszka

The angiotensin (Ang)-(1-12)/Ang II pathway contributes to cardiac pathology. However, its involvement in the development of peripheral endothelial dysfunction associated with heart failure (HF) remains unknown. Therefore, this study aimed to characterise the effect of exogenous Ang-(1-12) and its conversion to Ang II on endothelial function using the murine model of HF (Tgαq*44 mice), focusing on the role of chymase and vascular-derived thromboxane A₂ (TXA₂). Ex vivo myographic assessments of isolated aorta showed impaired endothelium-dependent vasodilation in late-stage HF in 12-month-old Tgαq*44 mice. However, endothelium-dependent vasodilation was fully preserved in the early stage of HF in 4-month-old Tgαq*44 mice and 4- and 12-month-old FVB control mice. Ang-(1-12) impaired endothelium-dependent vasodilation in 4- and 12-month-old Tgαq*44 mice, that was associated with increased Ang II production. The chymase inhibitor chymostatin did not inhibit this response. Interestingly, TXA₂ production reflected by TXB₂ measurement was upregulated in response to Ang-(1-12) and Ang II in aortic rings isolated from 12-month-old Tgαq*44 mice but not from 4-month-old Tgαq*44 mice or age-matched FVB mice. Furthermore, in vivo magnetic resonance imaging showed that Ang-(1-12) impaired endothelium-dependent vasodilation in the aorta of Tgαq*44 mice and FVB mice. However, this response was inhibited by angiotensin I converting enzyme (ACE) inhibitor; perindopril, angiotensin II receptor type 1 (AT₁) antagonist; losartan and TXA₂ receptor (TP) antagonist-picotamide in 12-month-old-Tgαq*44 mice only. In conclusion, the chymase-independent vascular Ang-(1-12)/Ang II pathway and subsequent TXA₂ overactivity contribute to systemic endothelial dysfunction in the late stage of HF in Tgαq*44 mice. Therefore, the vascular TXA₂ receptor represents a pharmacotherapeutic target to improve peripheral endothelial dysfunction in chronic HF.

01 Feb 2024·Hospital pharmacy

Perindopril/Indapamide-Induced Photosensitivity

Article

Author: Denguezli, Mohamed ; Ben Salem, Chaker ; Zayani, Hanen ; Sahnoun, Dhouha ; Slim, Roudha

01 Feb 2024·Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie

Effects of telmisartan on metabolic syndrome components: a comprehensive review

Review

Author: Hosseinzadeh, Hossein ; Imenshahidi, Mohsen ; Roohbakhsh, Ali

Telmisartan is an antagonist of the angiotensin II receptor used in the management of hypertension (alone or in combination with other antihypertensive agents. It belongs to the drug class of angiotensin II receptor blockers (ARBs). Among drugs of this class, telmisartan shows particular pharmacologic properties, including a longer half-life than any other angiotensin II receptor blockers that bring higher and persistent antihypertensive activity. In hypertensive patients, telmisartan has superior efficacy than other antihypertensive drugs (losartan, valsartan, ramipril, atenolol, and perindopril) in controlling blood pressure, especially towards the end of the dosing interval. Telmisartan has a partial PPARγ-agonistic effect whilst does not have the safety concerns of full agonists of PPARγ receptors (thiazolidinediones). Moreover, telmisartan has an agonist activity on PPARα and PPARδ receptors and modulates the adipokine levels. Thus, telmisartan could be considered as a suitable alternative option, with multi-benefit for all components of metabolic syndrome including hypertension, diabetes mellitus, obesity, and hyperlipidemia. This review will highlight the role of telmisartan in metabolic syndrome and the main mechanisms of action of telmisartan are discussed and summarized. Many studies have demonstrated the useful properties of telmisartan in the prevention and improving of metabolic syndrome and this well-tolerated drug can be greatly proposed in the treatment of different components of metabolic syndrome. However, larger and long-duration studies are needed to confirm these findings in long-term observational studies and prospective trials and to determine the optimum dose of telmisartan in metabolic syndrome.

News (Medical) associated with Perindopril Erbumine

21 Feb 2024

·www.biospace.com

Discover this new generic drug in the PERINDOPRIL range

MONTREAL, Feb. 21, 2024 /CNW/ - Pharmascience Canada is proud to announce the launch of pms-PERINDOPRIL-AMLODIPINE (perindopril arginine and amlodipine), a drug indicated for the treatment of mild to moderate essential hypertension in adults aged 18 to 65 for whom combination therapy is appropriate. This oral treatment contains two medicines, perindopril arginine and amlodipine. They work together to control the blood pressure. pms-PERINDOPRIL-AMLODIPINE are available in bottles of 100 tablets and comes in the following dosage forms: 3.5 mg / 2.5 mg (this treatment is indicated for initial therapy in patients with mild to moderate essential hypertension.) 7 mg / 5 mg 14 mg / 10 mg This medication is a generic equivalent of Viacoram MD1. pms-PERINDOPRIL-AMLODIPINE tablets are available at affordable prices. « We are excited to introduce Perindopril Amlodipine to the Canadian market, as it reflects our mission to improve the health and quality of life of Canadians through innovative and high-quality products, » said Mike Dutton, Vice-President and General Manager of Pharmascience Canada. « Perindopril Amlodipine is manufactured in our Canadian facility which is another example of how we leverage our expertise and capabilities to deliver value to our customers and patients. » ABOUT PHARMASCIENCE INC. Founded in 1983, Pharmascience Inc. is the largest pharmaceutical employer in Quebec with 1,500 employees proudly headquartered in Montreal. Pharmascience Inc. is a full-service privately owned pharmaceutical company with strong roots in Canada and a growing global reach with product distribution in over 50 countries. Ranked 50th among Canada's top 100 Research & Development (R&D) investors in 2022, with 40-50 million dollars invested each year, Pharmascience Inc. is among the largest drug manufacturers in Canada. Pharmascience Inc. has strong values based on the importance of investing in its employees and young people. Through various programs and initiatives, the company ensures it supports their personal development and life. In 2024, the company was awarded Great Place to Work certification for the third year running. PRVIACORAM®1 is a registered trademark owned by Servier Canada Inc. For product information, please contact Pharmascience's Medical Information Department at 1-888-550-6060. SOURCE Pharmascience Inc.

Drug Approval

05 Sep 2023

·www.biospace.com

Pharmascience Canada launches a new generic drug to treat hypertension

[05-September-2023] MONTREAL, Sept. 5, 2023 /CNW/ - pms-PERINDOPRIL-INDAPAMIDE (perindopril erbumine / indapamide) is used in adults for the initial treatment of mild to moderate essential hypertension (high blood pressure). pms-PERINDOPRIL-INDAPAMIDE (perindopril erbumine/ indapamide) are a combination of perindopril erbumine, an angiotensin converting enzyme (ACE) inhibitor, and indapamide, a chlorosulphamoyl diuretic. These two active ingredients act synergistically to lower blood pressure in hypertensive patients of all ages. pms-PERINDOPRIL-INDAPAMIDE comes in the following dosage forms: Tablets of 2 mg perindopril erbumine/ 0.625 mg indapamide. Tablets of 4 mg perindopril erbumine/ 1.25 mg indapamide. Tablets of 8 mg perindopril erbumine/ 2.5 mg indapamide. pms-PERINDOPRIL-INDAPAMIDE is a generic equivalent to Coversyl® Plus, Coversyl® Plus LD and Coversyl® Plus HD and has the same safety and efficacy as Coversyl®. pms-PERINDOPRIL-INDAPAMIDE tablets are offered at a lower price than brand-name products. "The Pharmascience team is happy to bring to market pms-Perindopril-Indapamide used for the initial treatment of high blood pressure. The availability of pms-Perindopril-Indapamide gives every Canadian an affordable and important treatment option! At Pharmascience, we take tremendous pride in our locally produced medicines and will continue to focus on growing our portfolio with quality medications needed for all Canadians!" - mentioned Mike Dutton, Vice President, and General Manager of Pharmascience Canada. ABOUT PHARMASCIENCE INC. Founded in 1983, Pharmascience Inc. is the largest pharmaceutical employer in Quebec with 1,500 employees proudly headquartered in Montreal. Pharmascience Inc. is a full-service privately owned pharmaceutical company with strong roots in Canada and a growing global reach with product distribution in over 50 countries. Ranked 50th among Canada's top 100 Research & Development (R&D) investors in 2022, with 40-50 million dollars invested each year, Pharmascience Inc. is among the largest drug manufacturers in Canada. Pharmascience Inc. has strong values based on the importance of investing in its employees and young people. Through various programs and initiatives, the company ensures it supports their personal development and life. In 2023, Pharmascience Inc. has proudly been recognized for its investments by being selected as one of Canada's Top Employers for Young People as part of Canada's Top 100 Employers. Pharmascience is now certified as a Great Place to Work for a second year in a row. For product information, please contact Pharmascience's Medical Information Department at 1-888-550-6060. Coversyl® Plus, Coversyl® Plus LD and Coversyl® Plus HD are registered trademark owned by Servier Canada Inc. SOURCE Pharmascience Inc.

Drug Approval

21 Aug 2023

·www.pharmaceutical-technology.com

Calliditas inches closer to full approval for IgA nephropathy drug

Akosua Mireku @AkosuaMireku1 IgA nephropathy is a kidney disorder that causes inflammation. The US Food and Drug Administration (FDA) has granted Calliditas Therapeutics’ immunoglobulin A (IgA) nephropathy (IgAN) drug Tarpeyo (budesonide) a priority review for a decision on granting it a “full approval”. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report. The FDA previously granted the drug accelerated approval as the first therapy for the treatment of IgAN, in December 2021. The agency has now set a prescription drug user fee act (PDUFA) date for this supplemental new drug application (sNDA) application of 20 December 2023. Recommended Reports Reports LOA and PTSR Model - Deutetrabenazine in Dyskinesia GlobalData Reports LOA and PTSR Model - (amlodipine + bisoprolol + indapamide + perindopril) GlobalData View all The FDA accepted Calliditas’s sNDA for the drug based on the full data set from the Phase III NefIgArd clinical study (NCT03643965). Patients treated for nine months with Tarpeyo showed a significant reduction of approximately 30%, in the urine protein-to-creatinine ratio compared with the placebo group. The trial also met its primary endpoint of estimated glomerular filtration rate (eGFR), as the therapy demonstrated a significant kidney protective effect over the placebo. Tarpeyo is an oral glucocorticoid anti-inflammatory agent that suppresses the gut immune system. This allows the drug to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression. The drug was previously being developed under the brand name Nefecon, with the company renaming the novel targeted-release formulation of the drug as Tarpeyo. This formulation comprises a 4mg enteric-coated capsule, designed to remain intact until it reaches the patient’s ileum. In the 18 August press release announcing the priority review, Calliditas’ CEO Renee Aguiar-Lucander said: “The significant eGFR treatment benefit observed across the entire study population provides further evidence that TARPEYO can be disease-modifying, potentially significantly delaying the need for dialysis or kidney transplantation for patients at risk.” IgAN is a kidney disorder caused by a build-up of antibodies in the kidney tissue. This can cause the kidneys to gradually fail, requiring some patients to undergo dialysis, or in severe cases, kidney transplants. The condition mostly develops between the late teens and late 30s. Calliditas is also working with its European partner, STADA Arzneimettel, to push a European Commission approval of the drug under the brand name Kinpeygo, following its 2022 European conditional authorisation . The Sweden-headquartered company also received conditional approval for the treatment from the UK’s Medicines and healthcare products regulatory agency (MHRA) in February 2023. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report.

Clinical ResultPhase 3Drug ApprovalPriority ReviewAccelerated Approval

100 Deals associated with Perindopril Erbumine

External Link

KEGG	Wiki	ATC	Drug Bank
D00624	Perindopril Erbumine	C09AA04	DB00790

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Heart Diseases	JP	Daiichi Sankyo Co., Ltd.	28 Sep 2005
Heart Failure	CA	Servier Pharmaceuticals LLCStartup	31 Dec 1994
Hypertension	CA	Servier Pharmaceuticals LLCStartup	31 Dec 1994
Agranulocytosis	US	Symplmed Pharmaceuticals LLC	30 Dec 1993
Angioedema	US	Symplmed Pharmaceuticals LLC	30 Dec 1993
Collagen Diseases	US	Symplmed Pharmaceuticals LLC	30 Dec 1993
Coronary Artery Disease	US	Symplmed Pharmaceuticals LLC	30 Dec 1993
Essential Hypertension	US	Symplmed Pharmaceuticals LLC	30 Dec 1993
Myocardial Infarction	US	Symplmed Pharmaceuticals LLC	30 Dec 1993
Renal Insufficiency	US	Symplmed Pharmaceuticals LLC	30 Dec 1993

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus	Phase 3	CA	Servier Pharmaceuticals LLCStartup	01 Apr 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESC2023	Phase 3	Essential Hypertension	532	Perindopril arginine 5 mg/Indapamide 1.25 mg/Amlodipine 5 mg (P5/I1.25/A5)	uxahchmylx(smxqrbrkae) = sjwqouwlqv drzmcvoibh (ynqamsebpo ) 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)	mrfyhabtxc(yefxrgrcfq) = vvblwfcoer ykpxsnglly (qgsiuickef ) View more
ESC2023	Not Applicable	First line	-	Perindopril-based regimens	jarhyvxvld(qucohjahxc) = jrmosudfou agqstggbsl (kxyzfvzvve, 87–8973)	-	27 Aug 2023
				Losartan-based regimens	jarhyvxvld(qucohjahxc) = otkgawzzxt agqstggbsl (kxyzfvzvve, 104–9365)
ESC2022	Not Applicable	Hypertension Second line	-	Perindopril/amlodipine+indapamide	sdaguezmnn(wriogovbnk) = 11 adverse reactions gelznmkrtd (tgckzxujyr )	-	07 Apr 2022
ISRCTN67799751 (Pubmed \| Adv Ther)	Not Applicable	Hypertension	22	Perindopril arginine/indapamide single-pill combination (Pa/I SPC)	bpnalmsjwt(zkrdbhhdgo) = xusaspbnfz dbbpgnhbed (ivyjkhtwue ) View more	-	01 Dec 2020
ESC2019	Not Applicable	Chronic heart failure metalloproteinase-9 (MMP-9) \| tissue inhibitor of metalloproteinase 1 (TIMP-1) \| E-selectin ... View more	30	Perindopril A 5 mg/day	qcopgmxylj(hvahiebdkj) = adgnmivbob cxqyqoogga (fwujpnfwvv ) View more	-	27 May 2019
				Perindopril A 10 mg/day	qcopgmxylj(hvahiebdkj) = grsbjumuas cxqyqoogga (fwujpnfwvv ) View more
ESC2018	Not Applicable	Hypertension	796	Perindopril/indapamide/amlodipine fixed-dose combination	auugmlfxum(eqboplddmb) = krqxqejpqx pstayacazn (fykozhcjub ) View more	-	26 Aug 2018
NCT01669434 (CTgov)	Phase 4	Hypotension	291	LISINOPRIL+Captopril+ENALAPRILAT+BENAZEPRIL HYDROCHLORIDE+PERINDOPRIL ERBUMINE+RAMIPRIL+QUINAPRIL HYDROCHLORIDE+Enalapril Maleate+Perindopril Arginine+FOSINOPRIL SODIUM+TRANDOLAPRIL+MOEXIPRIL HYDROCHLORIDE (ACEI Omission)	nohpzchhhb(sbeztvpoku) = orfgrjjkmk meebduxybi (vexezirzly, sxzjpeyvob - ckmrsqvnoh) View more	-	11 Dec 2017
				ACEI continuation (ACEI Continuation)	nohpzchhhb(sbeztvpoku) = jnusotccql meebduxybi (vexezirzly, vpiidzxpmb - whecujuxdt) View more
ESC2017	Not Applicable	Hypertension	-	Perindopril+Atorvastatin	jvrpbbstfk(tplrfyxxjj) = 4.5% of patients preqhinfru (qxkabdzugq ) View more	-	26 Aug 2017
ESC2016	Not Applicable	Vascular Diseases	-	Perindopril on top of β-blocker	dyuoapdkpb(imlespfjuy) = ogvraxkjze qkgvmfwgdz (hpmuirlwfl )	Positive	28 Aug 2016
				Perindopril without β-blocker	dyuoapdkpb(imlespfjuy) = cngbyxhlhd qkgvmfwgdz (hpmuirlwfl )
ESC2016	Not Applicable	Hypertension	-	Free combination of perindopril and amlodipine	pmovzayqdq(gadqwddesk) = hwpewdxqyy xrpvirodzw (xuxfpmtlug )	-	28 Aug 2016
				Fixed dose combination of perindopril and amlodipine	pmovzayqdq(gadqwddesk) = qqzkgcubad xrpvirodzw (xuxfpmtlug )

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