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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR IRBESARTAN AND HYDROCHLOROTHIAZIDE


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All Clinical Trials for Irbesartan And Hydrochlorothiazide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00095394 ↗ Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension Completed Sanofi Phase 3 2004-09-01 The purpose of this clinical research is to learn if severe hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.
NCT00095394 ↗ Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension Completed Bristol-Myers Squibb Phase 3 2004-09-01 The purpose of this clinical research is to learn if severe hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.
NCT00095550 ↗ Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With Moderate Hypertension Completed Sanofi Phase 3 2004-10-01 The purpose of this clinical research is to learn if moderate hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.
NCT00095550 ↗ Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With Moderate Hypertension Completed Bristol-Myers Squibb Phase 3 2004-10-01 The purpose of this clinical research is to learn if moderate hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.
NCT00110422 ↗ Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome Completed Sanofi Phase 4 2005-11-01 The purpose of this clinical research study is to learn if irbesartan is superior to hydrochlorothiazide relative to effects on insulin sensitivity and glucose metabolism in hypertensive patients with metabolic syndrome.
NCT00110422 ↗ Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome Completed Bristol-Myers Squibb Phase 4 2005-11-01 The purpose of this clinical research study is to learn if irbesartan is superior to hydrochlorothiazide relative to effects on insulin sensitivity and glucose metabolism in hypertensive patients with metabolic syndrome.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Irbesartan And Hydrochlorothiazide

Condition Name

Condition Name for Irbesartan And Hydrochlorothiazide
Intervention Trials
Hypertension 13
Metabolic Syndrome 1
Microalbuminuria 1
Type 2 Diabetes 1
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Condition MeSH

Condition MeSH for Irbesartan And Hydrochlorothiazide
Intervention Trials
Hypertension 12
Metabolic Syndrome 1
Malnutrition 1
Albuminuria 1
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Clinical Trial Locations for Irbesartan And Hydrochlorothiazide

Trials by Country

Trials by Country for Irbesartan And Hydrochlorothiazide
Location Trials
United States 71
Canada 18
Germany 6
Taiwan 4
France 4
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Trials by US State

Trials by US State for Irbesartan And Hydrochlorothiazide
Location Trials
Texas 4
Connecticut 2
Washington 2
Colorado 2
Virginia 2
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Clinical Trial Progress for Irbesartan And Hydrochlorothiazide

Clinical Trial Phase

Clinical Trial Phase for Irbesartan And Hydrochlorothiazide
Clinical Trial Phase Trials
Phase 4 9
Phase 3 3
N/A 3
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Clinical Trial Status

Clinical Trial Status for Irbesartan And Hydrochlorothiazide
Clinical Trial Phase Trials
Completed 15
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Clinical Trial Sponsors for Irbesartan And Hydrochlorothiazide

Sponsor Name

Sponsor Name for Irbesartan And Hydrochlorothiazide
Sponsor Trials
Sanofi 10
Bristol-Myers Squibb 4
Roxane Laboratories 2
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Sponsor Type

Sponsor Type for Irbesartan And Hydrochlorothiazide
Sponsor Trials
Industry 16
Other 4
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Irbesartan and Hydrochlorothiazide: A Comprehensive Review of Clinical Trials, Market Analysis, and Projections

Introduction

Irbesartan and hydrochlorothiazide (HCTZ) are commonly used in combination to treat hypertension and other related cardiovascular conditions. This article delves into the clinical trials, market analysis, and future projections for this combination therapy.

Clinical Trials and Efficacy

Antihypertensive Effects

Clinical trials have consistently shown that the combination of irbesartan and HCTZ is highly effective in reducing both systolic and diastolic blood pressure. In a study involving 844 patients, the combination therapy resulted in significant reductions in blood pressure, with 73%, 96%, and 72% of patients achieving systolic, diastolic, and combined blood pressure treatment goals, respectively[1].

Renal Protection

Irbesartan, as an angiotensin receptor blocker (ARB), has been approved for reducing the progression of renal disease in patients with nephropathy and type 2 diabetes. When combined with HCTZ, it offers a synergistic effect in managing blood pressure and protecting renal function[4].

Safety and Tolerability

The combination of irbesartan and HCTZ has been found to be well tolerated in various clinical trials. Adverse events were generally mild and transient, with the most common being headache, musculoskeletal pain, dizziness, upper respiratory infection, and fatigue. The incidence of adverse events was similar to or lower than that of placebo in many studies[3][5].

Dose-Response Studies

A dose-response study involving 683 patients with mild-to-moderate hypertension demonstrated that the combination of irbesartan and HCTZ produced additive reductions in both systolic and diastolic blood pressure. The study showed that the combination therapy was safe and effective, with no treatment-related serious adverse events[5].

Market Analysis

Cost-Effectiveness

Studies have indicated that irbesartan in combination with HCTZ is a cost-effective antihypertensive treatment strategy. A cost-effectiveness analysis in a Swedish healthcare setting found that irbesartan/HCTZ was a dominant strategy compared to other ARB combinations, offering better health effects at lower costs[2].

Market Position

Irbesartan, marketed under various brand names such as Avalide, Avapro, and Karvea, has established itself as a significant player in the antihypertensive market. The combination with HCTZ enhances its market position by offering a comprehensive treatment option for patients with uncontrolled hypertension or those not expected to be well controlled on monotherapy[4].

Patient Adherence

Patient adherence is a crucial factor in the long-term management of hypertension. A post-marketing survey in Switzerland showed that more than 80% of patients were still on irbesartan at four months, indicating good patient acceptance and adherence to the medication[1].

Market Projections

Growing Demand for Antihypertensive Medications

The global demand for antihypertensive medications is expected to rise due to increasing prevalence of hypertension, particularly in aging populations and those with comorbid conditions like diabetes and cardiovascular disease.

Competitive Landscape

The antihypertensive market is highly competitive, with various ARBs and other classes of antihypertensive drugs available. However, the combination of irbesartan and HCTZ is likely to maintain its market share due to its proven efficacy, safety, and cost-effectiveness[2].

Future Developments

Future developments may include further studies on the long-term benefits of irbesartan/HCTZ in preventing cardiovascular events and renal disease progression. Additionally, there could be a focus on developing more patient-friendly formulations and combination therapies to enhance adherence and outcomes.

Key Takeaways

  • Efficacy: Irbesartan and HCTZ combination therapy is highly effective in reducing blood pressure and protecting renal function.
  • Safety: The combination is well tolerated with a low incidence of adverse events.
  • Cost-Effectiveness: It offers a cost-effective treatment strategy compared to other antihypertensive combinations.
  • Market Position: The combination enhances the market position of irbesartan by providing a comprehensive treatment option.
  • Future Projections: The demand for this combination is expected to grow due to the increasing prevalence of hypertension and its associated conditions.

FAQs

What is the primary mechanism of action of irbesartan?

Irbesartan prevents angiotensin II from binding to the AT1 receptor, leading to vascular smooth muscle relaxation and reduced aldosterone secretion, thereby lowering blood pressure[4].

What are the common adverse events associated with irbesartan and HCTZ combination therapy?

Common adverse events include headache, musculoskeletal pain, dizziness, upper respiratory infection, and fatigue. These events are generally mild and transient[3][5].

Is irbesartan and HCTZ combination therapy cost-effective?

Yes, studies have shown that irbesartan/HCTZ is a cost-effective antihypertensive treatment strategy, offering better health effects at lower costs compared to other combinations[2].

Can irbesartan and HCTZ be used in patients with renal impairment?

The combination can be used in patients with mild to moderate renal impairment (creatinine clearance >30 mL/min), but it is not recommended for those with more severe renal impairment[3].

What is the impact of irbesartan and HCTZ on patient adherence?

The combination is well accepted by patients, with high adherence rates observed in post-marketing surveys, indicating good patient acceptance and adherence to the medication[1].

Are there any specific populations where irbesartan and HCTZ should be avoided?

Irbesartan should be avoided in pregnancy or in women who are breastfeeding due to potential harmful effects on the development of newborns[1].

Sources

  1. A Review of the Antihypertensive and Renal-protective Effects of Irbesartan - USC Journal
  2. Cost-effectiveness of irbesartan/hydrochlorothiazide in patients with hypertension - PubMed
  3. Avalide (irbesartan and hydrochlorothiazide) tablets - FDA
  4. Irbesartan: Uses, Interactions, Mechanism of Action - DrugBank Online
  5. Matrix study of irbesartan with hydrochlorothiazide in mild-to-moderate hypertension - American Journal of Hypertension

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