CLINICAL TRIALS PROFILE FOR VALSARTAN AND HYDROCHLOROTHIAZIDE

All Clinical Trials for Valsartan And Hydrochlorothiazide

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.
NCT00171353 ↗	A Study to Describe Vascular and Renal Effects and Safety of Valsartan in Patients With High Blood Pressure	Completed	Novartis	Phase 4	2004-07-01	One hundred twenty patients with arterial hypertension and albuminuria (some amount of albumin in urine) are given valsartan 80 mg and then160 mg to normalize blood pressure. Hydrochlorothiazide (diuretic) 12.5-25 mg added if necessary.

Clinical Trial Conditions for Valsartan And Hydrochlorothiazide

Condition Name

Condition Name for Valsartan And Hydrochlorothiazide
Intervention	Trials
Hypertension	38
METABOLIC SYNDROME	2
Diabetes Mellitus, Type 2	2
Healthy Normotensive Participants	2

Condition MeSH

Condition MeSH for Valsartan And Hydrochlorothiazide
Intervention	Trials
Hypertension	39
Essential Hypertension	4
Diabetes Mellitus	2
Albuminuria	2

Clinical Trial Locations for Valsartan And Hydrochlorothiazide

Trials by Country

Trials by Country for Valsartan And Hydrochlorothiazide
Location	Trials
United States	152
Canada	8
Switzerland	8
Germany	7
Taiwan	4

Trials by US State

Trials by US State for Valsartan And Hydrochlorothiazide
Location	Trials
New Jersey	10
California	7
Alabama	6
Texas	6
Oklahoma	6

Clinical Trial Progress for Valsartan And Hydrochlorothiazide

Clinical Trial Phase

Clinical Trial Phase for Valsartan And Hydrochlorothiazide
Clinical Trial Phase	Trials
Phase 4	21
Phase 3	19
N/A	3

Clinical Trial Status

Clinical Trial Status for Valsartan And Hydrochlorothiazide
Clinical Trial Phase	Trials
Completed	41
Terminated	1
Withdrawn	1

Clinical Trial Sponsors for Valsartan And Hydrochlorothiazide

Sponsor Name

Sponsor Name for Valsartan And Hydrochlorothiazide
Sponsor	Trials
Novartis	26
Boehringer Ingelheim	3
Novartis Pharmaceuticals	3

Sponsor Type

Sponsor Type for Valsartan And Hydrochlorothiazide
Sponsor	Trials
Industry	37
Other	9

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

Introduction

Valsartan and hydrochlorothiazide is a combination medication used to treat high blood pressure (hypertension). This article delves into the clinical trials, market analysis, and future projections for this drug, providing a comprehensive overview of its efficacy, market trends, and growth prospects.

Clinical Trials and Efficacy

Overview of Clinical Trials

Clinical trials have consistently shown that the combination of valsartan and hydrochlorothiazide is highly effective in reducing blood pressure in patients with hypertension. These trials, ranging from 8 weeks to 3 years, have demonstrated significant reductions in both systolic and diastolic blood pressure compared to monotherapy with either drug alone[3].

Specific Trial Outcomes

A multicenter, randomized, and double-blind phase IV trial compared the efficacy and safety of fixed-dose combinations of amlodipine/valsartan (AML/VAL) and valsartan/hydrochlorothiazide (VAL/HCTZ). The trial found that both combinations significantly reduced mean sitting diastolic blood pressure (msDBP), with the AML/VAL group showing a reduction of −9.44 mm Hg and the VAL/HCTZ group showing a reduction of −7.47 mm Hg after 8 weeks[1].

Long-Term Efficacy

Long-term studies have also supported the sustained efficacy of valsartan/hydrochlorothiazide. These studies indicate that the blood pressure reductions observed after 3 months of treatment were maintained over 1, 2, or 3 years, highlighting the long-term effectiveness of this combination[3].

Mechanism of Action

Valsartan

Valsartan is an angiotensin II receptor blocker (ARB) that works by blocking the action of angiotensin II, a substance in the body that causes blood vessels to tighten. By blocking this substance, valsartan relaxes the blood vessels and lowers blood pressure[4].

Hydrochlorothiazide

Hydrochlorothiazide is a thiazide diuretic that reduces the amount of water in the body by increasing urine flow. This reduction in fluid volume helps lower blood pressure[4].

Market Analysis

Global Market Size and Growth

The global valsartan/hydrochlorothiazide market has been experiencing significant growth. As of 2023, the market size was substantial, and it is projected to continue growing at a compound annual growth rate (CAGR) from 2024 to 2031. The 80mg/12.5mg dosage segment accounted for a noticeable share of the global market and is expected to see significant growth in the near future[2].

Regional Analysis

The market is segmented into major regions including North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region provides detailed insights into revenue share, current trends, and future market opportunities. The hospital segment is expected to expand at a significant CAGR, retaining its position throughout the forecast period[2].

Key Players

Companies such as Novartis and Lupin are focusing on strategy building to strengthen their product portfolios and expand their business in the global market. These companies are driving the market growth through innovative strategies and product developments[2].

Market Trends and Drivers

Increasing Prevalence of Hypertension

The rising prevalence of hypertension globally is a significant driver for the valsartan/hydrochlorothiazide market. As more people are diagnosed with high blood pressure, the demand for effective treatments like valsartan/hydrochlorothiazide increases[2].

Advancements in Pharmaceutical Technology

Advancements in pharmaceutical technology and the development of new formulations are also driving market growth. These advancements improve the efficacy and safety profiles of the medication, making it more appealing to both patients and healthcare providers[5].

Challenges and Restraints

Adverse Events

While the combination of valsartan and hydrochlorothiazide is generally well-tolerated, common adverse events include headache, dizziness, and fatigue. Additionally, hypokalemia (low potassium levels) can occur in some patients, although valsartan helps mitigate the potassium-lowering effects of hydrochlorothiazide[3].

Regulatory and Economic Factors

Regulatory changes and economic factors can also impact the market. For instance, patent expirations and the entry of generic versions can affect the market share of branded products. Economic constraints in certain regions can also limit market growth[2].

Future Projections

Market Growth

The global valsartan/hydrochlorothiazide market is projected to continue its growth trajectory from 2025 to 2031. The market size is expected to increase significantly, driven by the increasing prevalence of hypertension and the effectiveness of the medication[2].

Emerging Markets

Emerging markets, particularly in the Asia Pacific region, are expected to contribute significantly to the growth of the valsartan/hydrochlorothiazide market. These regions have large populations with growing healthcare needs, presenting substantial opportunities for market expansion[2].

Key Takeaways

• Clinical Efficacy: Valsartan/hydrochlorothiazide is highly effective in reducing blood pressure in patients with hypertension, outperforming monotherapy with either drug alone.
• Market Growth: The global market for valsartan/hydrochlorothiazide is expected to grow significantly from 2025 to 2031, driven by increasing hypertension prevalence and advancements in pharmaceutical technology.
• Regional Trends: The hospital segment and emerging markets, especially in the Asia Pacific region, are key areas of growth.
• Challenges: Common adverse events and regulatory/economic factors may impact market dynamics.

FAQs

Q: What is the mechanism of action of valsartan and hydrochlorothiazide?

A: Valsartan blocks the action of angiotensin II, relaxing blood vessels, while hydrochlorothiazide reduces fluid volume by increasing urine flow, both contributing to lower blood pressure[4].

Q: What are the common adverse events associated with valsartan/hydrochlorothiazide?

A: Common adverse events include headache, dizziness, fatigue, and hypokalemia, although the incidence is not significantly different from placebo recipients[3].

Q: How effective is valsartan/hydrochlorothiazide in long-term blood pressure control?

A: Clinical trials have shown that the combination maintains effective blood pressure control over long-term periods, up to 3 years[3].

Q: Which regions are expected to drive the growth of the valsartan/hydrochlorothiazide market?

A: Emerging markets, particularly in the Asia Pacific region, along with the hospital segment, are expected to drive significant growth[2].

Q: What are the key drivers of the valsartan/hydrochlorothiazide market?

A: The increasing prevalence of hypertension and advancements in pharmaceutical technology are key drivers of the market growth[2].

Sources

1. A multicenter, randomized, and double-blind phase IV clinical trial to compare the efficacy and safety of fixed-dose combinations of amlodipine... - Medicine[1]
2. Global Valsartan Hydrochlorothiazide Market Report 2024 Edition - Cognitive Market Research[2]
3. Valsartan/hydrochlorothiazide: a review of its... - PubMed[3]
4. Valsartan and hydrochlorothiazide (oral route) - Mayo Clinic[4]
5. Global Valsartan Hydrochlorothiazide Preparation Market 2023 by Manufacturers, Regions, Type and Application, Forecast to 2029 - Market Research Reports[5]