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Last Updated: January 14, 2025

CLINICAL TRIALS PROFILE FOR HYDROCHLOROTHIAZIDE; VALSARTAN


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All Clinical Trials for hydrochlorothiazide; valsartan

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00168779 ↗ Randomized, Double-Blind, Placebo-Controlled, Forced-Titration, Comparing Telmisartan vs Valsartan. Taken Orally for Eight Weeks in Patients With Stage 1 and Stage 2 Hypertension Completed Boehringer Ingelheim Phase 4 2005-09-01 The primary objective of this study is to compare the effectiveness of telmisartan 80 mg / hydrochlorothiazide 25 mg [Micardis HCT] to valsartan 160 mg / hydrochlorothiazide 25 mg [Diovan HCT] and placebo in the treatment of Stage 1 and Stage 2 hypertension.
NCT00170937 ↗ A 16 Week Study to Evaluate the Effect on Insulin Sensitivity of Valsartan (320 mg) and Hydrochlorothiazide (25 mg) Combined and Alone, in Patients With Metabolic Syndrome Completed Novartis Phase 4 2004-11-01 The metabolic syndrome is a classification for patients with a constellation of risk factors which may include abdominal obesity, hypertension, elevated blood lipids and sugar. Three or more of these factors together constitute the metabolic syndrome and place these patients at a greater risk for the development of diabetes and cardiovascular diseases. The purpose of this study is to determine whether two common drugs to lower blood pressure, whether used separately or in combination, have different effects on blood sugar levels in patients diagnosed with the metabolic syndrome.
NCT00170989 ↗ Valsartan/Hydrochlorothiazide Combination in Hypertensive Patients Not Controlled With Valsartan Alone Completed Novartis Phase 3 2004-09-01 This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication.
NCT00171015 ↗ VALORY Study of Valsartan/Hydrochlorizide for Patients Who do Not Respond Adequately to Olmesartan Medoxomil Completed Novartis Phase 3 2004-12-01 To evaluate the efficacy of valsartan 160 mg/HCTZ 25 mg in patients not adequately responding to monotherapy with olmesartan medoxomil 40 mg or combination therapy with olmesartan medoxomil 20 mg plus HCTZ 12.5 mg by testing the hypothesis that valsartan 160 mg/HCTZ 25 mg significantly reduces the trough mean sitting diastolic blood pressure (MSDBP) after a 4-week treatment in the nonresponder population.
NCT00171054 ↗ Efficacy and Safety of Valsartan Versus Amlodipine in Postmenopausal Women With Hypertension Completed Novartis Phase 4 2003-09-01 The purpose of this study is compare treatment with valsartan with the possible addition of a diuretic, hydrochlorothiazide, on high blood pressure with the drug amlodipine with the possible addition of a diuretic, hydrochlorothiazide. In particular, the effect of treatment on the stiffness of the blood vessels will be studied.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for hydrochlorothiazide; valsartan

Condition Name

Condition Name for hydrochlorothiazide; valsartan
Intervention Trials
Hypertension 38
Healthy Normotensive Participants 2
Metabolic Syndrome 2
Diabetes Mellitus, Type 2 2
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Condition MeSH

Condition MeSH for hydrochlorothiazide; valsartan
Intervention Trials
Hypertension 39
Essential Hypertension 4
Metabolic Syndrome X 2
Metabolic Syndrome 2
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Clinical Trial Locations for hydrochlorothiazide; valsartan

Trials by Country

Trials by Country for hydrochlorothiazide; valsartan
Location Trials
United States 152
Canada 8
Switzerland 8
Germany 7
Taiwan 4
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Trials by US State

Trials by US State for hydrochlorothiazide; valsartan
Location Trials
New Jersey 10
California 7
Alabama 6
Texas 6
Oklahoma 6
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Clinical Trial Progress for hydrochlorothiazide; valsartan

Clinical Trial Phase

Clinical Trial Phase for hydrochlorothiazide; valsartan
Clinical Trial Phase Trials
Phase 4 21
Phase 3 19
N/A 3
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Clinical Trial Status

Clinical Trial Status for hydrochlorothiazide; valsartan
Clinical Trial Phase Trials
Completed 41
Withdrawn 1
Terminated 1
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Clinical Trial Sponsors for hydrochlorothiazide; valsartan

Sponsor Name

Sponsor Name for hydrochlorothiazide; valsartan
Sponsor Trials
Novartis 26
Boehringer Ingelheim 3
Novartis Pharmaceuticals 3
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Sponsor Type

Sponsor Type for hydrochlorothiazide; valsartan
Sponsor Trials
Industry 37
Other 9
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Hydrochlorothiazide; valsartan Market Analysis and Financial Projection

Hydrochlorothiazide and Valsartan: Clinical Trials, Market Analysis, and Projections

Introduction

Hydrochlorothiazide and valsartan are two potent antihypertensive drugs often used in combination to treat hypertension and other cardiovascular conditions. This article delves into the clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials and Efficacy

VICTORY Trial

One of the significant clinical trials involving valsartan and its combination with hydrochlorothiazide (HCTZ) is the VICTORY trial. This international, multicentre, open-label, prospective trial evaluated the efficacy and safety of valsartan and the combination of valsartan and HCTZ in patients with mild to moderate arterial hypertension. The trial included 365 patients from five countries and demonstrated that both valsartan and the combination therapy effectively reduced systolic and diastolic blood pressure. The mean absolute decrease in systolic and diastolic blood pressure was 26.60 mm Hg and 14.84 mm Hg, respectively, which was statistically significant. Notably, 90.6% of patients achieved target blood pressure levels by the end of the trial[1].

Safety Profile

The VICTORY trial also highlighted the good tolerability profile of both valsartan and the combination therapy. Only 1.1% of patients discontinued treatment due to adverse reactions related to the drugs. The overall incidence of adverse reactions was low, with the most common side effects being mild and transient, such as headache and dizziness[1].

Additional Indications

Valsartan has been studied in over 60 clinical trials involving more than 100,000 patients, leading to its approval for additional indications including heart failure and post-myocardial infarction. These studies have also shown that valsartan improves sexual function in hypertensive men and is effective in various patient populations, including the elderly, obese, and those with diabetes mellitus[1].

Market Analysis

Global Market Size

The global market for valsartan and hydrochlorothiazide combination therapy was valued at $198 million in 2023. It is forecasted to grow to $267 million by 2030, with a compound annual growth rate (CAGR) of 4.5% during the period from 2024 to 2030[2].

Regional Market

The market is segmented into regions such as North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. The North American market is a significant segment, with the global market analysis providing detailed insights into regional and country-level trends[3].

Key Players

Major players in the valsartan and hydrochlorothiazide market include Novartis, Wan Gao, CR Pharm, Chang Zhou Siyao Pharm, and Cisen Pharmaceutical. These companies are focusing on expanding their product portfolios and strengthening their market presence through strategic initiatives[2][3].

Market Segmentation

By Type

The market is segmented based on the dosage and formulation of the combination therapy. For example, the 80mg/12.5mg segment accounted for a noticeable share of the global market in 2023 and is projected to experience significant growth in the near future[3].

By Application

The application segment includes various healthcare settings such as hospitals, clinics, and outpatient services. The hospital segment is expected to expand at a significant CAGR throughout the forecast period[3].

Market Trends and Drivers

Growing Prevalence of Hypertension

The increasing prevalence of hypertension globally is a major driver for the growth of the valsartan and hydrochlorothiazide market. As the population ages and lifestyle factors contribute to higher blood pressure rates, the demand for effective antihypertensive treatments is expected to rise.

Technological Advancements

Advancements in pharmaceutical technology and the development of more effective and tolerable drug combinations are also driving market growth. The combination of valsartan and HCTZ offers a synergistic effect that enhances blood pressure control, making it a preferred choice for many patients[3].

Regulatory Environment

Regulatory approvals and guidelines also play a crucial role in the market. For instance, the FDA approval of Diovan (valsartan) for various indications has contributed to its widespread use and acceptance in clinical practice[4].

Future Projections

Market Growth

The valsartan and hydrochlorothiazide market is expected to continue growing due to the increasing demand for antihypertensive medications. The forecasted CAGR of 4.5% from 2024 to 2030 indicates a steady and significant growth trajectory[2].

Emerging Markets

Emerging markets in regions like Asia Pacific and Latin America are expected to contribute significantly to the market growth. These regions have large populations with growing healthcare needs, which will drive the demand for affordable and effective antihypertensive treatments[3].

Key Takeaways

  • Efficacy and Safety: Valsartan and its combination with HCTZ have been proven to be effective and safe in reducing blood pressure in patients with mild to moderate hypertension.
  • Market Size: The global market for this combination therapy is projected to grow from $198 million in 2023 to $267 million by 2030.
  • Key Players: Major pharmaceutical companies like Novartis and others are key players in this market.
  • Market Trends: The growing prevalence of hypertension, technological advancements, and favorable regulatory environments are driving market growth.
  • Future Projections: The market is expected to grow at a CAGR of 4.5% from 2024 to 2030, with significant contributions from emerging markets.

FAQs

What is the primary indication for the combination of valsartan and hydrochlorothiazide?

The primary indication for the combination of valsartan and hydrochlorothiazide is the treatment of hypertension, particularly in patients with mild to moderate arterial hypertension.

What are the key findings of the VICTORY trial?

The VICTORY trial showed that valsartan and the combination of valsartan and HCTZ effectively reduce systolic and diastolic blood pressure, with 90.6% of patients achieving target blood pressure levels. The treatment was also found to have a good tolerability profile.

Who are the major players in the valsartan and hydrochlorothiazide market?

Major players include Novartis, Wan Gao, CR Pharm, Chang Zhou Siyao Pharm, and Cisen Pharmaceutical.

What is the forecasted market size for valsartan and hydrochlorothiazide by 2030?

The global market for valsartan and hydrochlorothiazide is forecasted to reach $267 million by 2030.

What is the expected CAGR for the valsartan and hydrochlorothiazide market from 2024 to 2030?

The expected CAGR for the valsartan and hydrochlorothiazide market from 2024 to 2030 is 4.5%.

Sources

  1. The efficacy and safety of valsartan and combination of valsartan ... - Polish Heart Journal[1]
  2. Valsartan Hydrochlorothiazide Preparation - Market Size - Valuates Reports[2]
  3. Global Valsartan Hydrochlorothiazide Market Report 2024 Edition - Cognitive Market Research[3]
  4. Diovan (valsartan) - FDA - FDA[4]

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