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Last Updated: April 9, 2025

CLINICAL TRIALS PROFILE FOR BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE


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All Clinical Trials for benazepril hydrochloride; hydrochlorothiazide

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00367094 ↗ Combination of Benazepril Plus Hydrochlorothiazide in Chinese Patients With Mild to Moderate Essential Hypertension Completed Novartis Phase 3 2006-07-01 This study will evaluate efficacy and safety data for benazepril/hydrochlorothiazide in adult Chinese patients with mild to moderate essential hypertension. Patients whose blood pressure is not adequately controlled with benazepril monotherapy during a 4 week run-in period will be randomly allocated to double blind treatment over 8 weeks with either a combination of benazepril/hydrochlorothiazide per day or continuation of benazepril per day.
NCT00170950 ↗ Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension Terminated Novartis Phase 3 2003-10-01 A comparison study of two combination drugs, amlodipine/benazepril and benazepril/HCTZ to evaluate the effectiveness of the combination on reducing heart disease and death in a high risk hypertensive population.
NCT00649038 ↗ Fed Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg Completed Mylan Pharmaceuticals Phase 1 2002-12-01 The objective of this study was to investigate the bioequivalence of Mylan benazepril HCl and hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination tablets following a single, oral 40 mg/50 mg (2 x 20 mg/25 mg) dose administration under fed conditions.
NCT00649597 ↗ Fasting Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg Completed Mylan Pharmaceuticals Phase 1 2002-11-01 The objective of this study was to investigate the bioequivalence of Mylan benazepril HCl and hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination tablets following a single, oral 40 mg/50 mg (2 x 20 mg/25 mg) dose administration under fasting conditions.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

Clinical Trial Conditions for benazepril hydrochloride; hydrochlorothiazide

Condition Name

4411000.511.522.533.54HypertensionHealthyAlbuminuriaDiabetes Mellitus, Type 2[disabled in preview]
Condition Name for benazepril hydrochloride; hydrochlorothiazide
Intervention Trials
Hypertension 4
Healthy 4
Albuminuria 1
Diabetes Mellitus, Type 2 1
[disabled in preview] 0
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Condition MeSH

4111000.511.522.533.54HypertensionEssential HypertensionDiabetes Mellitus, Type 2Diabetes Mellitus[disabled in preview]
Condition MeSH for benazepril hydrochloride; hydrochlorothiazide
Intervention Trials
Hypertension 4
Essential Hypertension 1
Diabetes Mellitus, Type 2 1
Diabetes Mellitus 1
[disabled in preview] 0
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Clinical Trial Locations for benazepril hydrochloride; hydrochlorothiazide

Trials by Country

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Trials by Country for benazepril hydrochloride; hydrochlorothiazide
Location Trials
United States 5
China 2
Finland 1
Denmark 1
Sweden 1
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Trials by US State

+
Trials by US State for benazepril hydrochloride; hydrochlorothiazide
Location Trials
North Carolina 2
North Dakota 2
New Jersey 1
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Clinical Trial Progress for benazepril hydrochloride; hydrochlorothiazide

Clinical Trial Phase

25.0%25.0%25.0%25.0%0-0.200.20.40.60.811.21.41.61.822.2Phase 4Phase 3Phase 1[disabled in preview]
Clinical Trial Phase for benazepril hydrochloride; hydrochlorothiazide
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
Phase 1 2
[disabled in preview] 2
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Clinical Trial Status

75.0%12.5%12.5%00123456CompletedTerminatedActive, not recruiting[disabled in preview]
Clinical Trial Status for benazepril hydrochloride; hydrochlorothiazide
Clinical Trial Phase Trials
Completed 6
Terminated 1
Active, not recruiting 1
[disabled in preview] 0
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Clinical Trial Sponsors for benazepril hydrochloride; hydrochlorothiazide

Sponsor Name

trials000111112222NovartisMylan PharmaceuticalsRanbaxy Laboratories Limited[disabled in preview]
Sponsor Name for benazepril hydrochloride; hydrochlorothiazide
Sponsor Trials
Novartis 2
Mylan Pharmaceuticals 2
Ranbaxy Laboratories Limited 2
[disabled in preview] 1
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Sponsor Type

87.5%12.5%001234567IndustryOther[disabled in preview]
Sponsor Type for benazepril hydrochloride; hydrochlorothiazide
Sponsor Trials
Industry 7
Other 1
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BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE: Clinical Trials, Market Analysis, and Projections

Introduction

Benazepril hydrochloride and hydrochlorothiazide are commonly used in combination to treat hypertension. This article delves into the clinical trials, market analysis, and projections for this drug combination, highlighting its efficacy, market trends, and future outlook.

Clinical Trials Overview

Efficacy and Comparative Studies

Several clinical trials have evaluated the efficacy of benazepril hydrochloride combined with hydrochlorothiazide. The ACCOMPLISH trial, for instance, compared the combination of benazepril plus amlodipine with benazepril plus hydrochlorothiazide in patients at high risk for cardiovascular events. The trial was terminated early due to the significant reduction in cardiovascular events in the benazepril-amlodipine group, showing a 19.6% relative risk reduction compared to the benazepril-HCTZ group[1].

In another study, the combination of benazepril and hydrochlorothiazide demonstrated sustained antihypertensive effects for at least 24 hours, with increased efficacy at higher doses of either component. This combination also showed no consistent changes in serum potassium levels, which is a significant benefit given the potassium loss associated with diuretic use[4].

Demographic Efficacy

The efficacy of benazepril monotherapy is somewhat less in black patients compared to non-black patients, but the combination therapy with hydrochlorothiazide appears to be effective across different racial groups[2][4].

Pharmacodynamics and Pharmacokinetics

Mechanism of Action

Benazepril hydrochloride inhibits angiotensin-converting enzyme (ACE), while hydrochlorothiazide acts as a thiazide diuretic. The combination potentiates the antihypertensive action by blocking the renin-angiotensin-aldosterone axis and reducing fluid volume, thereby lowering blood pressure[4].

Absorption and Elimination

Benazepril is converted to its active metabolite, benazeprilat, primarily in the liver. Peak plasma concentrations of benazeprilat are reached 1-2 hours after dosing in the fasting state and 2-4 hours in the non-fasting state. Hydrochlorothiazide is not metabolized and is eliminated primarily through the urine, with an elimination half-life of about 10 hours[2][4].

Market Analysis

Market Size and Growth

The benazepril hydrochloride market was valued at USD 100 billion in 2023 and is projected to reach USD 147.75 billion by 2031, growing at a compound annual growth rate (CAGR) of 5% from 2024 to 2031. This growth is driven by the increasing incidence of hypertension and chronic renal disease, the expanding elderly population, and advancements in pharmaceutical research and development[3].

Key Market Drivers

  • Increasing Prevalence of Hypertension: The global prevalence of hypertension is estimated to increase, driven largely by increases in economically developing nations. According to the WHO, 1.13 billion people suffer from hypertension, and this number is expected to rise[5].
  • Aging Population: The growing elderly population, especially in developed areas, is more susceptible to various health issues, including hypertension and chronic renal disease, thus driving the demand for benazepril hydrochloride[3].
  • Advances in R&D: Continuous research and development efforts to improve therapeutic efficacy and safety profiles are contributing to market growth. New formulations and the development of novel drugs are expected to further boost the market[3].
  • Government Policies and Healthcare Spending: Supportive government policies that encourage healthcare affordability and accessibility, along with rising healthcare spending, are significant factors driving the market[3].

Market Trends

  • New Product Launches: The launch of novel formulations and drugs is expected to flourish the market. Pharmaceutical companies are focusing on developing more effective and safer treatments, which will drive market growth[5].
  • Increased Awareness: Rising awareness of the importance of cardiovascular health and the adoption of preventative measures are presenting profitable opportunities for major players in the pharmaceutical sector[3].

Challenges and Side Effects

Side Effects

Despite the benefits, hydrochlorothiazide is associated with side effects such as potassium loss, which can be mitigated by the combination with benazepril. However, other side effects like increased urination, dizziness, and electrolyte imbalances can hamper market growth[5].

Renal Impairment

The elimination half-life of hydrochlorothiazide is increased in patients with renal impairment, which necessitates careful dosing adjustments in such patients[2].

Key Takeaways

  • Clinical Efficacy: The combination of benazepril hydrochloride and hydrochlorothiazide is effective in reducing blood pressure and cardiovascular events.
  • Market Growth: The market is expected to grow significantly due to the increasing prevalence of hypertension, the aging population, and advancements in R&D.
  • Key Drivers: Government policies, healthcare spending, and new product launches are driving the market.
  • Challenges: Side effects and the need for careful dosing in patients with renal impairment are challenges that need to be addressed.

FAQs

What is the primary mechanism of action of benazepril hydrochloride and hydrochlorothiazide?

The primary mechanism of action involves benazepril inhibiting ACE and hydrochlorothiazide acting as a thiazide diuretic, collectively reducing blood pressure by blocking the renin-angiotensin-aldosterone axis and reducing fluid volume[4].

What are the key drivers of the benazepril hydrochloride market?

The key drivers include the increasing prevalence of hypertension, the growing elderly population, advances in R&D, and supportive government policies that encourage healthcare affordability and accessibility[3].

How does the combination of benazepril and hydrochlorothiazide affect serum potassium levels?

The combination tends to reduce the potassium loss associated with diuretic use, with no consistent changes in serum potassium levels observed in clinical trials[4].

What are the potential side effects of hydrochlorothiazide?

Potential side effects include increased urination, dizziness, electrolyte imbalances, and potassium loss, although the latter is mitigated when combined with benazepril[5].

How does renal impairment affect the pharmacokinetics of hydrochlorothiazide?

Renal impairment increases the elimination half-life of hydrochlorothiazide, necessitating careful dosing adjustments in patients with impaired renal function[2].

Sources

  1. European Society of Cardiology - Thiazide diuretics in hypertension[1]
  2. DailyMed - BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE[2]
  3. Market Research Intellect - Global Benazepril Hydrochloride Market[3]
  4. FDA - Lotensin HCT - accessdata.fda.gov[4]
  5. Allied Market Research - Hydrochlorothiazide Market Size | Industry Growth, (2021-2030)[5]

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