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Last Updated: June 17, 2025

CLINICAL TRIALS PROFILE FOR AVAPRO


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All Clinical Trials for Avapro

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00095290 ↗ Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria Completed Sanofi Phase 4 2004-09-01 Albumin in the urine is usually a signal that you might be at risk of cardiovascular complications. The purpose of this study is to determine if the albumin in your urine can be decreased by the treatment regimen that consists of irbesartan taken at the same time with ramipril.
NCT00095290 ↗ Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria Completed Bristol-Myers Squibb Phase 4 2004-09-01 Albumin in the urine is usually a signal that you might be at risk of cardiovascular complications. The purpose of this study is to determine if the albumin in your urine can be decreased by the treatment regimen that consists of irbesartan taken at the same time with ramipril.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Avapro

Condition Name

Condition Name for Avapro
Intervention Trials
Hypertension 7
Ebola Virus Disease 1
Focal Segmental Glomerulosclerosis 1
Kidney Failure, Chronic 1
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Condition MeSH

Condition MeSH for Avapro
Intervention Trials
Hypertension 5
Atrial Fibrillation 2
Stress, Psychological 1
Virus Diseases 1
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Clinical Trial Locations for Avapro

Trials by Country

Trials by Country for Avapro
Location Trials
United States 123
Canada 31
Germany 8
Mexico 5
Russian Federation 4
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Trials by US State

Trials by US State for Avapro
Location Trials
Texas 7
Georgia 5
Wisconsin 5
Pennsylvania 5
Ohio 5
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Clinical Trial Progress for Avapro

Clinical Trial Phase

Clinical Trial Phase for Avapro
Clinical Trial Phase Trials
Phase 4 3
Phase 3 5
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Avapro
Clinical Trial Phase Trials
Completed 10
Unknown status 3
Active, not recruiting 1
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Clinical Trial Sponsors for Avapro

Sponsor Name

Sponsor Name for Avapro
Sponsor Trials
Sanofi 6
Bristol-Myers Squibb 5
Roxane Laboratories 2
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Sponsor Type

Sponsor Type for Avapro
Sponsor Trials
Industry 19
Other 9
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AVAPRO: Clinical Trials, Market Analysis, and Projections

Introduction

AVAPRO, also known as irbesartan, is an angiotensin II receptor antagonist used primarily for the treatment of hypertension and diabetic nephropathy. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Irbesartan Diabetic Nephropathy Trial (IDNT)

One of the pivotal clinical trials for AVAPRO was the Irbesartan Diabetic Nephropathy Trial (IDNT). This randomized, placebo- and active-controlled, double-blind multicenter study involved 1715 patients with type 2 diabetes, hypertension, and nephropathy. Patients were randomized to receive either AVAPRO 300 mg, amlodipine 10 mg, or a placebo. The study showed that AVAPRO significantly reduced the risk of doubling serum creatinine, end-stage renal disease (ESRD), or death by 20% compared to the placebo group. Additionally, AVAPRO reduced proteinuria by about 27% and slowed the rate of renal function loss by 18.2%[3].

Efficacy and Safety Profile

Efficacy

The IDNT trial demonstrated that AVAPRO is effective in slowing the progression of diabetic nephropathy. The drug reduced the primary composite endpoint of doubling serum creatinine, ESRD, or death. It also showed a significant reduction in proteinuria, a key indicator of kidney damage[3].

Safety

AVAPRO has been shown to have a consistent and favorable safety profile. In the IDNT trial, the overall safety profile of AVAPRO was comparable to the placebo and amlodipine groups. The most common adverse effects were similar across all treatment groups, indicating that AVAPRO is well-tolerated[3].

Market Analysis

Current Market Size and Growth

The irbesartan market, which includes AVAPRO, was valued at USD 2.23 billion in 2022. It is projected to reach USD 3.34 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 5.0% from 2024 to 2030. This growth is driven by the increasing prevalence of hypertension and diabetic nephropathy, as well as the rising demand for effective antihypertensive drugs[5].

Key Drivers

  • Increasing Prevalence of Hypertension and Diabetic Nephropathy: The growing number of patients with hypertension and diabetic nephropathy is a significant driver for the irbesartan market.
  • Aging Population: The rising aging population increases the incidence of cardiovascular diseases, further boosting the demand for irbesartan.
  • Generic Versions: The demand for generic versions of irbesartan, following patent expirations, is another key driver for market growth[5].

Market Trends and Forecast

Regional Growth

The irbesartan market is expected to see significant growth across various regions. Emerging economies, particularly in Asia-Pacific, are anticipated to drive market expansion due to rising disposable incomes and urbanization. In developed regions like North America and Europe, the market will be sustained by the continued demand for effective antihypertensive drugs and the expansion of market players into untapped regions[5].

Technological and Legislative Trends

The integration of new technologies and legislative support for healthcare are expected to further boost the market. Sustainability trends and the growing awareness of cardiovascular diseases will also contribute to the market's growth[5].

Future Prospects

Continued Demand for Antihypertensive Drugs

The future prospects for the irbesartan market look promising, driven by the continued demand for effective antihypertensive drugs. As the global population ages and the prevalence of hypertension and diabetic nephropathy increases, the market is expected to expand significantly[5].

Expansion into Untapped Regions

Market players are expected to expand into untapped regions, particularly in emerging economies, where there is a growing need for affordable and effective antihypertensive medications. This expansion will be fueled by rising consumer demand and the availability of generic versions of irbesartan[5].

Key Takeaways

  • AVAPRO has demonstrated significant efficacy in slowing the progression of diabetic nephropathy and reducing proteinuria.
  • The drug has a favorable safety profile, making it well-tolerated for long-term use.
  • The irbesartan market is projected to grow at a CAGR of 5.0% from 2024 to 2030, driven by increasing prevalence of hypertension and diabetic nephropathy.
  • Emerging economies and the availability of generic versions are key drivers for market growth.
  • Technological advancements and legislative support will further boost the market.

FAQs

What was the primary endpoint of the IDNT trial for AVAPRO?

The primary endpoint of the IDNT trial was the time to occurrence of any one of the following events: doubling of baseline serum creatinine, end-stage renal disease (ESRD), or death[3].

How does AVAPRO compare to other antihypertensive drugs in terms of efficacy?

AVAPRO has been shown to be as effective as other antihypertensive drugs, such as amlodipine, in reducing blood pressure and slowing the progression of renal disease. It also has a significant effect on reducing proteinuria[3].

What are the key drivers for the growth of the irbesartan market?

The key drivers include the increasing prevalence of hypertension and diabetic nephropathy, the rising aging population, and the demand for generic versions of irbesartan following patent expirations[5].

Which regions are expected to drive the growth of the irbesartan market?

Emerging economies, particularly in the Asia-Pacific region, are expected to drive significant growth. Developed regions like North America and Europe will also contribute to the market expansion[5].

How does the safety profile of AVAPRO compare to other treatments?

AVAPRO has a consistent and favorable safety profile, comparable to placebo and other antihypertensive drugs like amlodipine. It is generally well-tolerated for long-term use[3].

Sources

  1. Travere Therapeutics Announces Confirmatory Data from Phase 3 PROTECT Study - Travere Therapeutics[1].
  2. Pro AV Revenue Forecast to Reach $422 Billion by 2029 - AVIXA[2].
  3. AVAPRO - accessdata.fda.gov - FDA[3].
  4. Drug Trials Snapshots: FILSPARI - FDA[4].
  5. Irbesartan Market Key Drivers and Forecast 2025-2032 - Verified Market Reports[5].
Last updated: 2025-01-05

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