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Last Updated: March 24, 2025

CLINICAL TRIALS PROFILE FOR CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE


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All Clinical Trials for Candesartan Cilexetil And Hydrochlorothiazide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00383929 ↗ Antihypertensive Efficacy and Safety of Candesartan/HCT 32/12.5 and 32/25 mg in Comparison With Candesartan 32 mg Completed AstraZeneca Phase 3 2006-09-01 In this study it is intended to compare the blood pressure lowering effect of the combination of candesartan cilexetil (candesartan) 32 mg and hydrochlorothiazide (HCT) 25 mg and the combination of candesartan 32 mg and HCT 12.5 mg to that of candesartan 32 mg alone in patients whose blood pressure is not well controlled on candesartan 32 mg monotherapy. The Primary Objectives are to compare sitting BP lowering effect of candesartan/HCT 32/25 mg and candesartan/HCT 32/12.5 mg with that of candesartan 32 mg, respectively.
NCT00434967 ↗ Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and Placebo Completed AstraZeneca Phase 3 2007-01-01 The aim is to compare the blood pressure lowering effect of the combination of candesartan cilexetil (candesartan) 32 mg and hydrochlorothiazide (HCT) 25 mg to that of candesartan 32 mg alone, HCT 25 mg alone and placebo in hypertensive adults.
NCT00621153 ↗ Candesartan Effect in Second Stage Arterial Hypertension Completed AstraZeneca Phase 4 2008-02-01 To compare the changes in mean sitting DBP from baseline after 4 weeks of therapy with either candesartan cilexetil/HCT combination therapy or candesartan cilexetil monotherapy regimen
NCT01012479 ↗ Efficacy and Safety of Candesartan Cilexetil Plus Hydrochlorothiazide in Subjects With Severe Hypertension Completed Takeda Phase 4 2009-10-01 The purpose of this study is to see if Candesartan, once daily (QD), added with Hydrochlorothiazide may be helpful in treating people with newly diagnosed severe essential hypertension.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Candesartan Cilexetil And Hydrochlorothiazide

Condition Name

Condition Name for Candesartan Cilexetil And Hydrochlorothiazide
Intervention Trials
Hypertension 5
Stage II Hypertension 1
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Condition MeSH

Condition MeSH for Candesartan Cilexetil And Hydrochlorothiazide
Intervention Trials
Hypertension 6
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Clinical Trial Locations for Candesartan Cilexetil And Hydrochlorothiazide

Trials by Country

Trials by Country for Candesartan Cilexetil And Hydrochlorothiazide
Location Trials
Ukraine 2
Germany 2
Latvia 1
Russian Federation 1
Former Serbia and Montenegro 1
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Clinical Trial Progress for Candesartan Cilexetil And Hydrochlorothiazide

Clinical Trial Phase

Clinical Trial Phase for Candesartan Cilexetil And Hydrochlorothiazide
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Candesartan Cilexetil And Hydrochlorothiazide
Clinical Trial Phase Trials
Completed 6
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Clinical Trial Sponsors for Candesartan Cilexetil And Hydrochlorothiazide

Sponsor Name

Sponsor Name for Candesartan Cilexetil And Hydrochlorothiazide
Sponsor Trials
AstraZeneca 3
Takeda 2
GlaxoSmithKline 1
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Sponsor Type

Sponsor Type for Candesartan Cilexetil And Hydrochlorothiazide
Sponsor Trials
Industry 6
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Candesartan Cilexetil and Hydrochlorothiazide: Clinical Trials, Market Analysis, and Projections

Introduction

Candesartan cilexetil and hydrochlorothiazide is a combination medication widely used for the treatment of hypertension. This article delves into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Efficacy and Safety

Clinical trials have extensively evaluated the efficacy and safety of the combination of candesartan cilexetil and hydrochlorothiazide. In a series of controlled clinical trials involving 4588 patients, the combination was compared to the individual components and placebo. These trials, lasting 8 to 12 weeks, demonstrated significant blood pressure reductions. The combination of 32 mg candesartan cilexetil and 25 mg hydrochlorothiazide resulted in placebo-adjusted decreases in sitting systolic and diastolic blood pressures of 16-19/9-11 mm Hg[1][2].

Blood Pressure Reduction

Most of the antihypertensive effect was observed within 1 to 2 weeks, with the full effect achieved within 4 weeks. Long-term studies up to 1 year showed that the blood pressure lowering effect was maintained consistently. The antihypertensive effect was similar across different age groups and genders, and the response was consistent in both black and non-black patients[1][2].

Safety Profile

The combination therapy did not significantly affect serum potassium levels, with no patient discontinued due to changes in serum potassium. Additionally, no appreciable changes in heart rate were observed during the controlled trials[2].

Specific Trial Details

A notable Phase III study (D2456C00002) compared the blood pressure lowering effect of the combination of 32 mg candesartan cilexetil and 25 mg hydrochlorothiazide against each component alone and placebo. This double-blind, randomized, multicentre study involved 2207 hypertensive adults and confirmed the efficacy and safety of the combination[4].

Market Analysis

Global Market Size

As of 2024, the global candesartan cilexetil market size is estimated to be USD 584.2 million. This market is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.60% from 2024 to 2031, reaching USD 800.4 million by 2031[3].

Driving Factors

The growth of the candesartan cilexetil market is driven by several factors, including the increasing incidence of hypertension, rising awareness about cardiovascular health, and advancements in drug delivery. Public health campaigns and educational initiatives have heightened awareness about cardiovascular diseases, leading to earlier diagnosis and treatment initiation. This increased awareness and proactive approach to health management are significant drivers of the market[3].

Market Segmentation

The market is segmented primarily by application, with hypertension being the dominant category due to its widespread prevalence globally. The fastest-growing category is diabetic nephropathy, driven by the increasing incidence of diabetes and the need for medications like candesartan cilexetil to manage renal function and reduce proteinuria[3].

Regional Analysis

The market is analyzed across various regions, including Asia-Pacific, Europe, North America, South America, and the Middle East and Africa. Each region presents different growth opportunities and challenges, with the Asia-Pacific region showing significant potential due to its large population and increasing healthcare expenditure[5].

Market Projections

Future Growth

The market for candesartan cilexetil and hydrochlorothiazide is expected to continue growing due to sustained demand for effective hypertension management. The increasing incidence of diabetes and the associated need for renal protection will further drive the adoption of this medication in the diabetic nephropathy segment[3].

Competitive Landscape

The market is competitive, with key players including AstraZeneca, ANI Pharmaceuticals, TEVA, Mylan, Dr. Reddy's Laboratories, and Zydus Pharmaceuticals. These companies are focusing on technological innovations, strategic partnerships, and expanding their product portfolios to maintain market share[5].

Regulatory and Government Support

Government funding and support for cardiovascular health initiatives are expected to facilitate market growth. Regulatory policies and guidelines that emphasize the importance of blood pressure management will also contribute to the increased adoption of candesartan cilexetil and hydrochlorothiazide[5].

Key Takeaways

  • Clinical Efficacy: The combination of candesartan cilexetil and hydrochlorothiazide has been shown to significantly reduce blood pressure in clinical trials.
  • Market Growth: The global market for candesartan cilexetil is projected to grow at a CAGR of 4.60% from 2024 to 2031.
  • Driving Factors: Increasing incidence of hypertension, rising awareness about cardiovascular health, and advancements in drug delivery are key drivers of market growth.
  • Regional Opportunities: The Asia-Pacific region presents significant growth opportunities due to its large population and increasing healthcare expenditure.
  • Competitive Landscape: The market is competitive with several key players focusing on technological innovations and strategic partnerships.

FAQs

What are the primary uses of candesartan cilexetil and hydrochlorothiazide?

Candesartan cilexetil and hydrochlorothiazide are primarily used for the treatment of hypertension and also in managing diabetic nephropathy.

How effective is the combination of candesartan cilexetil and hydrochlorothiazide in reducing blood pressure?

The combination has been shown to reduce sitting systolic and diastolic blood pressures by 16-19/9-11 mm Hg in clinical trials.

What are the key drivers of the candesartan cilexetil market growth?

The key drivers include the increasing incidence of hypertension, rising awareness about cardiovascular health, and advancements in drug delivery.

Which region shows the most potential for market growth?

The Asia-Pacific region shows significant potential due to its large population and increasing healthcare expenditure.

Who are the major players in the candesartan cilexetil market?

Major players include AstraZeneca, ANI Pharmaceuticals, TEVA, Mylan, Dr. Reddy's Laboratories, and Zydus Pharmaceuticals.

Sources

  1. Drugs.com: Candesartan and Hydrochlorothiazide Tablets: Package Insert.
  2. FDA: Atacand HCT (candesartan cilexetil-hydrochlorothiazide) tablets label.
  3. Cognitive Market Research: Global candesartan cilexetil market report.
  4. AstraZeneca Clinical Trials: Antihypertensive efficacy and safety of Candesartan/HCT 32/25 mg.
  5. OpenPR: Candesartan and Hydrochlorothiazide Market By Deployment, Capability, Equipment and End User Analysis by 2026.

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