ACE inhibitors(Angiotensin-converting enzyme inhibitors), ACE2 inhibitors(Angiotensin-converting enzyme 2 inhibitors), NCC inhibitors(Thiazide-sensitive sodium-chloride cotransporter inhibitors)

Therapeutic Areas

Cardiovascular Diseases

Active Indication

Hypertension

Inactive Indication-

Originator Organization

Merck Sharp & Dohme Corp.

Active Organization

Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.

Almatica Pharma LLC

Inactive Organization

Merck Research Laboratories Massachusetts LLC

Drug Highest PhaseApproved

First Approval Date

US (16 Feb 1989),

Hypertension

Regulation-

Structure

Molecular FormulaC7H8ClN3O4S2

InChIKeyJZUFKLXOESDKRF-UHFFFAOYSA-N

CAS Registry58-93-5

View All Structures (2)

Clinical Trials associated with Hydrochlorothiazide/Lisinopril

CTR20201306 / CompletedNot Applicable

赖诺普利氢氯噻嗪片在中国健康受试者中的单剂量空腹/餐后口服给药的一项单中心、随机、开放生物等效性试验

[Translation] A single-center, randomized, open-label bioequivalence trial of lisinopril-hydrochlorothiazide tablets in healthy Chinese subjects after single-dose oral administration on an empty stomach or after a meal

主要研究目的：以赖诺普利氢氯噻嗪片（商品名：ZESTORETIC®）为参比制剂，以江苏天士力帝益药业有限公司生产的赖诺普利氢氯噻嗪片为受试制剂，通过单中心、随机、开放、单剂量空腹/餐后口服给药的临床研究，评价受试制剂和参比制剂在空腹/餐后状态下的生物等效性。次要研究目的：观察赖诺普利氢氯噻嗪在中国健康人群的安全性。

[Translation]

Main research purpose: Using lisinopril hydrochlorothiazide tablets (trade name: ZESTORETIC®) as the reference preparation and lisinopril hydrochlorothiazide tablets produced by Jiangsu Tasly Diyi Pharmaceutical Co., Ltd. as the test preparation, a single-center, randomized, open, single-dose fasting/fed oral clinical study was conducted to evaluate the bioequivalence of the test preparation and the reference preparation in the fasting/fed state. Secondary research purpose: Observe the safety of lisinopril hydrochlorothiazide in healthy Chinese people.

Start Date13 Jul 2020

Sponsor / Collaborator

Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.

NCT01831700 / CompletedPhase 1

A Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Comparative Bioavailability Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg of M/s Ipca Laboratories Ltd., India With Zestoretic® 20/25 Lisinopril/Hydrochlorothiazide Tablets of M/s AstraZeneca Pharmaceuticals LP, USA in Normal, Healthy, Adult, Human Subjects Under Fasting Condition

This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult, human subjects.

Start Date01 Oct 2012

Sponsor / Collaborator

Ipca Laboratories Ltd.

NCT01827878 / CompletedPhase 1

This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fed condition in normal, healthy, adult, human subjects.

Start Date01 Oct 2012

Sponsor / Collaborator

Ipca Laboratories Ltd.

100 Clinical Results associated with Hydrochlorothiazide/Lisinopril

100 Translational Medicine associated with Hydrochlorothiazide/Lisinopril

100 Patents (Medical) associated with Hydrochlorothiazide/Lisinopril

Literatures (Medical) associated with Hydrochlorothiazide/Lisinopril

01 Mar 2009·Cardiovascular TherapeuticsQ4 · MEDICINE

Effect of Seven Different Modalities of Antihypertensive Therapy on Pulse Pressure in Patients with Newly Diagnosed Stage I Hypertension

Q4 · MEDICINE

ArticleOA

Author: Baris Okcun ; Cengizhan Türkoğlu ; Gokhan Alici ; Gokmen Bellur ; Farid Aliyev ; Hakan Karpuz

In this study, we investigated the effect of different antihypertensive agents on pulse pressure (PP). The study was designed in a prospective manner and patients were sequentially allocated to one of the seven different therapy groups, according to the order of enrollment (every first patient to group I, every second patient to group II, and etc). Patients in group I received 10 mg of lisinopril, in group II 10/6.25 mg of lisinopril/hydrochlorothiazide, in group III 80 mg of valsartan, in group IV 80/6.25 mg of valsartan/hydrochlorothiazide, in group V 5 mg of amlodipine, in group VI 1.25 mg of indapamide, and finally those in group VII received 50 mg of atenolol. The reduction in PP was more significant in patients receiving lisinopril, lisinopril hydrochlorothiazide, valsartan, and valsartan hydrochlorothiazide, when compared with patients receiving indapamide, atenolol, and amlodipine (P < 0.05 for each group). Factors such as age, gender, and body mass index were not found to significantly influence the effectiveness of antihypertensive agents on PP. The reduction in PP was more apparent with lisinopril, lisinopril hydrochlorothiazide, valsartan, and valsartan hydrochlorothiazide in diabetic patients, when compared with those without diabetes (P < 0.001, P < 0.05). And also patients on therapy with 3‐hydroxy‐3‐methyl‐glutaryl‐CoA (HMG‐CoA) reductase inhibitors had a greater reduction in PP with lisinopril, lisinopril hydrochlorothiazide, valsartan, and valsartan hydrochlorothiazide (P < 0.001, P < 0.05).

01 Aug 1999·International Journal of DermatologyQ4 · MEDICINE

Generalized pustular eruptions associated with oral terbinafine

Q4 · MEDICINE

Review

Author: Wain L. White ; Joseph L. Jorizzo ; Michelle L. Bennett

An active 62-year-old man with noninsulin-dependent diabetes and chronic tinea pedis and tinea unguium developed a painless neurotrophic foot ulcer. His medical history was significant for mild hypercholesterolemia, chronic obstructive pulmonary disease, and long-term tobacco and alcohol use. Oral medications were Glyburide, Glucophage, Zestoretic, gemfibrozil, and aspirin, all of which had been administered daily for at least 8 months. There was no personal or family history of skin disease. After the ulcer failed to respond to conventional therapy, including wound care, debridement, and oral antibiotics, oral terbinafine was prescribed, 250 mg/day, for dermatophytosis-impaired wound healing. After 44 days of terbinafine therapy, the patient developed a generalized, erythematous, maculopapular, pruritic eruption accompanied by fatigue and chills. He denied cough, arthralgias, dizziness, hematuria, or exposure to anyone ill. Despite instructions to stop taking the medication, the patient erroneously continued to take terbinafine. One week later, he was referred to our institution. Physical examination revealed a nontoxic appearing middle-aged man with diffuse, confluent, erythematous plaques studded with pustules, lakes of pus, and crusted erosions and a fever of 38.9 °C ( Figs 1 and 2). Palms, soles, and mucous membranes were unaffected, and the groin was relatively spared. Toenails exhibited yellow–white discoloration, subungual debris, and onychauxis. Fingernails were normal. Lymphadenopathy was absent. A 1.3 cm by 1.7 cm superficial, painless ulcer without significant undermining was present on the left sole over the first metatarsophalangeal joint. There was decreased sensation from the toes to the midleg. Pedal pulses were palpable. Figure 1. Extensive pustular eruption of acute onset involving the trunk and extremities Download figure to PowerPoint Figure 2. Erythematous plaques, pustules, lakes of pus, and crusted erosions Download figure to PowerPoint Laboratory analyses revealed elevated white blood cell count (10.7 × 103 μL) with 11% eosinophils. Electrolytes, renal, thyroid, and liver function tests, urinalysis, and sedimentation rate were normal. A skin biopsy specimen showed an intraepidermal, spongiotic, vesiculopustular dermatitis with a superficial, perivascular, mixed inflammatory cell infiltrate of lymphocytes, neutrophils, and scattered eosinophils ( Figs 3 and 4). A periodic acid–Schiff stain was negative for fungi. Figure 3. Vesiculopustular dermatitis with diffuse superficial perivascular infiltrate (original magnification, ×10) Download figure to PowerPoint Figure 4. Subcorneal neutrophilic pustule, perivascular infiltrate of mononuclear cells, neutrophils, and occasional eosinophils (original magnification, ×40) Download figure to PowerPoint Terbinafine was stopped, but all other medications were continued. Hydrotherapy, twice-daily triamcinolone ointment, and a prednisone taper from 60 mg to 0 mg over 3 weeks were initiated. In 4 days, there was complete resolution of the fever and pustulosis and a significant reduction of the erythema. At 40 days, mildly pruritic, erythematous plaques persisted on the trunk and extremities. The temporal relationship strongly suggested terbinafine as the inciting agent in this patient. Oral provocation test was not performed due to unacceptable patient risk.

01 Feb 1997·Arzneimittel-Forschung

Effects of lisinopril or lisinopril/hydrochlorothiazide compared with adjusting of previous medication and intensifying non-pharmacological treatment in patients with mild to moderate hypertension.

Article

Author: Keinänen-Kiukaanniemi, S ; Pitkäjärvi, T ; Rasmusen, M ; Pekkarinen, T ; Romo, M ; Takala, J

The objective of this study was to compare the effectiveness of three treatment methods available for treatment of previously medicated patients with mild to moderate hypertension. The comparison was made between adjusting or increasing previous medication and switching the previous drug treatment to lisinopril (CAS 76547-98-3) or lisinopril hydrochlorothiazide (CAS 58-93-5) therapy and in both of these treatment groups the effect of additional intensified health education was tested. An open, randomised, controlled multi-centre study lasting 36 weeks involving 189 doctors and 69 nurses was carried out in 155 centres of primary health care and occupational health care system in Finland. The study population consisted of 1156 patients, age 30-70 years, (mean DBP 95-115 mmHg in the last three to five measurements during follow-up). The number of patients achieving target pressure (DBP < 90 mmHg) at the end of the study, defined daily doses (DDD) of antihypertensive drugs and side-effects in different treatment groups were regarded as the main outcome measures of the study. After exclusions and drop-outs the final analysis was carried out with 900 patients, 419 women (46.6%) and 481 men (53.4%). Patients receiving lisinopril treatment achieved target pressure significantly more often (p < 0.001) than those continuing their previous or adjusted medication at 36 weeks (59.2 and 55.5% vs 40.3 and 42.7%). Only a small additional but statistically non-significant blood pressure lowering effect was achieved with intensified non-pharmacological treatment at weeks 12 and 24, but this difference had disappeared at week 36. The mean DDDs of different antihypertensive drugs did not differ between groups except for female patients on previous or adjusted medication not receiving health education, the mean DDD being significantly (p < 0.05) higher at weeks 24 and 36 in this group. The profile of adverse effects at the end of the study clearly favoured patients on lisinopril treatment except for cough which was reported in 18% of patients vs 10% in the control groups. 81 patients on lisinopril treatment were withdrawn from the study because of cough. The results showed that hypertensive patients with poor treatment control benefit from all three approaches. A greater proportion of patients on lisinopril treatment achieved target pressure and also experienced fewer side effects than those continuing on adjusted previous medication. Intensified personal health education given once a month during six months had only a small additional beneficial effect on reaching the target pressure and this effect was lost in three months after the health education period.

News (Medical) associated with Hydrochlorothiazide/Lisinopril

02 Mar 2020

·www.bioportfolio.com

AstraZeneca completes divestment agreement with Atnahs Pharma for established hypertension medicines

AstraZeneca today announced that it has completed the previously communicated agreement with Atnahs Pharma (Atnahs) to divest its global commercial rights to Inderal (propranolol), Tenormin (atenolol), Tenoretic (atenolol, chlorthalidone fixed-dose combination), Zestril (lisinopril) and Zestoretic (lisinopril, hydrochlorothiazide fixed-dose combination).

Collaborate

27 Jan 2020

·endpts.com

After a brief break, AstraZeneca is back at divesting — handing off hypertension meds for $350M

On the same day that it’s getting back an experimental IL-23 drug from AbbVie and Allergan’s pre-merger divestiture exercise, AstraZeneca has engineered a sale of its own. The pharma giant is collecting $350 million from Atnahs Pharma for global commercial rights to a suite of five off-patent hypertension drugs: Inderal (propranolol), Tenormin (atenolol), Tenoretic (atenolol, chlorthalidone fixed-dose combination), Zestril (lisinopril) and Zestoretic (lisinopril, hydrochlorothiazide fixed-dose combination). Together, they generated sales of $132 million in 2018 in the markets covered by the deal, which excluded the US, India and Japan, according to AstraZeneca. The US and India rights were already divested, while the drugmaker is retaining rights to market in Japan. Atnahs, a specialist in “mature branded meds” with offices in the UK, Denmark, UAE, Australia and India, is also promising sales-contingent payments up to $40 million in the next two years. “This transaction supports our strategy to realise value from our portfolio of non-core mature brands, enabling further investment in new medicines,” Ruud Dobber, EVP of the BioPharmaceuticals business unit, said in a statement. During a transition period, AstraZeneca will continue to manufacture and supply the drugs to Atnahs. Inderal, Tenormin and Tenoretic are beta-blockers, while Zestril and Zestoretic both contain the same angiotensin-converting enzyme (ICE) inhibitor. In late 2018 AstraZeneca inked a flurry of deals to prune its portfolio and focus on the new flagship products, notably cancer drugs such as Lynparza, Imfinzi, Tagrisso and Calquence. A few months later in 2019, CEO Pascal Soriot executed a complete revamp of the company structure, dissolving the MedImmune subsidiary, enshrining the oncology franchise and refashioning everything else along that line. Previous divestitures have seen AstraZeneca let go of Nexium and Losec for stomach problems, anti-inflammatory drug Vimovo , RSV drug Synagis , as well as the respiratory therapies Alvesco, Omnaris and Zetonna.

Acquisition

100 Deals associated with Hydrochlorothiazide/Lisinopril

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypertension	US	Almatica Pharma LLC	20 Jul 1989

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00459056 (CTgov)	Phase 3	Obesity, Abdominal \| Hypertension	25	Lisinopril + HCTZ+Carvedilol CR + Lisinopril	nafpwthtfl(quouzgbwis) = quowrzcteh epmuptsztw (crapycoqab, gxraofkfwh - bwavybggau) View more	-	08 Nov 2013

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