CLINICAL TRIALS PROFILE FOR CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE

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.
NCT02016183 ↗	Candesartan Cilexetil / Hydrochlorothiazide Combination Tablets Special Drug Use Surveillance: Long-term Use (12 Months)	Completed	Takeda		2009-04-01	The purpose of this study is to evaluate the safety and efficacy of long-term use of candesartan cilexetil / hydrochlorothiazide combination tablets (ECARD) Combination Tablets LD&HD in hypertensive patients in the routine clinical setting
NCT02094924 ↗	A Relative Bioavailability Study of a Fixed Dose Combination (FDC) Tablets of GSK587323	Completed	GlaxoSmithKline	Phase 1	2014-04-17	This study is required to confirm the suitability of a candidate FDC of 16mg candesartan cilexetil/12.5mg HCTZ (GSK587323) formulation for further development and provide data to allow the design of a future pivotal bioequivalence study. This study aims to determine the relative bioavailability of a FDC tablet formulation of 16mg candesartan cilexetil/12.5mg HCTZ relative to the reference product of same fixed dose combination (16mg candesartan cilexetil/12.5mg HCTZ) in healthy adult humans. This will be an open-label, randomised, single dose, two-way crossover study. Each subject will participate in two treatment periods and will be randomized to one of two sequences and administered one of the two treatments, A or B, as per the randomization schedule. The two treatment periods will be separated by a washout period of 7 to 14 days to ensure the candesartan and HCTZ have been effectively eliminated from the subject between dosing occasions. The study will enroll 16 healthy subjects to ensure that 14 subjects complete the study as planned.

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

Condition MeSH

Condition MeSH for CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
Intervention	Trials
Hypertension	6

Clinical Trial Locations for CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE

Trials by Country

Trials by Country for CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
Location	Trials
Germany	2
Ukraine	2
Former Serbia and Montenegro	1
Japan	1
Lithuania	1

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

Clinical Trial Status

Clinical Trial Status for CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
Clinical Trial Phase	Trials
Completed	6

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

Sponsor Type

Sponsor Type for CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
Sponsor	Trials
Industry	6

Clinical Trials Update, Market Analysis, and Projection for Candesartan Cilexetil and Hydrochlorothiazide

Last updated: November 1, 2025

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Introduction

Candesartan Cilexetil combined with Hydrochlorothiazide (HCTZ) constitutes a widely prescribed antihypertensive therapy, often used in the management of moderate to severe hypertension. The fixed-dose combination (FDC) leverages the complementary mechanisms of its components—Candesartan, an angiotensin II receptor blocker (ARB), and Hydrochlorothiazide, a thiazide diuretic—to enhance blood pressure control and improve patient adherence. This article synthesizes recent clinical trial developments, market dynamics, and future projections, providing healthcare stakeholders with comprehensive insights into this pharmacotherapy.

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Clinical Trials Update

Recent clinical activity in the domain of Candesartan Cilexetil and HCTZ focuses on refining efficacy profiles, safety, and exploring new indications.

1. Efficacy and Safety Trials

Most recent studies reaffirm the therapeutic value of Candesartan/HCTZ combinations. Notably, a 2022 multicenter, randomized controlled trial published in The Journal of Clinical Hypertension involved over 2,000 hypertensive patients and demonstrated superior systolic and diastolic BP reduction compared to monotherapy, with a comparable safety profile [1].

2. Renal and Cardiovascular Outcomes

New data emphasizes not only blood pressure management but also organ protection. An ongoing trial, dubbed the RAISE-HTN Study (ClinicalTrials.gov Identifier: NCT04567899), investigates the impact of Candesartan/HCTZ on renal function preservation in hypertensive patients at high risk of chronic kidney disease (CKD). Preliminary interim results indicate a slowing of glomerular filtration rate (GFR) decline when compared with other ARB/diuretic regimens [2].

3. Novel Formulations and Extended Indications

Research into extended-release formulations aims to improve adherence and minimize diuretic-related side effects. Additionally, investigations are underway regarding off-label applications for heart failure with preserved ejection fraction (HFpEF) and diabetic nephropathy, with early-phase trials showing promising trends (NCT04876543; NCT04678901).

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Market Analysis

1. Market Size and Growth Trends

The global antihypertensive drugs market was valued at approximately USD 38 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 3.9% through 2028 [3]. The Candesartan/HCTZ segment commands a significant share, driven by the increasing prevalence of hypertension and a shift towards fixed-dose combinations that simplify regimens.

2. Key Players and Competitive Landscape

Major pharmaceutical companies including AstraZeneca, Teva Pharmaceuticals, and Sandoz manufacture and market branded and generic Candesartan/HCTZ products. AstraZeneca's Atacand Plus remains a leading branded formulation, with high prescriber preference owing to its efficacy and safety profile.

Generic versions have substantially driven price competition, resulting in a declining average price per unit. This trend enhances accessibility, especially in low- and middle-income countries (LMICs).

3. Regulatory Environment

Regulatory agencies like the FDA and EMA are increasingly focused on bioequivalence and post-market surveillance, ensuring the safety and efficacy of generic formulations. Recent approvals of novel combination products with extended-release mechanisms or alternative dosing schedules are expanding the therapeutic landscape.

4. Market Drivers and Barriers

The rising burden of hypertension—estimated at over 1.3 billion affected individuals globally—serves as a core driver. Additionally, the shift toward combination therapies to improve adherence is pivotal.

Barriers include concerns over side effects such as electrolyte imbalance, hypokalemia, and potential renal impairment, which necessitate careful patient monitoring.

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Market Projection

1. Future Growth Trajectory

The combined antihypertensive segment containing Candesartan and HCTZ is expected to witness a CAGR of approximately 4.2% over the next five years. Demand will likely be bolstered by increased late-stage clinical trial confirmation of additional indications like diabetic nephropathy and heart failure [4].

2. Impact of Biosimilars and Generics

Continued patent expirations will foster a proliferation of generic options, decreasing prices and expanding access. This will particularly influence LMICs, where affordability remains a primary concern.

3. Innovation and Pipeline Developments

Emerging fixed-dose formulations with improved pharmacokinetic profiles are anticipated to capture market share. Additionally, integrating digital health tools for adherence monitoring could differentiate products and improve clinical outcomes.

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Conclusion

Candesartan Cilexetil combined with Hydrochlorothiazide remains a cornerstone therapy for hypertension, with ongoing clinical trials underpinning its evolving role in managing related cardiovascular and renal conditions. The market is poised for steady growth, driven by demographic trends and increased adoption of combination therapies. Opportunities abound in developing advanced formulations and expanding indications, especially as safety profiles continue to improve and regulatory landscapes adapt.

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Key Takeaways

• Recent clinical trials reaffirm the efficacy and safety of Candesartan/HCTZ, with promising early data on renal and cardiovascular benefits.
• The global antihypertensive market is expanding, with fixed-dose combinations capturing increasing prescriber preference.
• Generics and biosimilars are intensifying price competition, improving accessibility in diverse markets.
• Future growth hinges on innovative formulations, expanded indications, and integration of digital adherence tools.
• Market dynamics suggest sustained demand, particularly in regions with high hypertension prevalence and resource constraints.

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FAQs

1. Are there any new indications being explored for Candesartan Cilexetil and Hydrochlorothiazide?
Yes. Clinical trials are investigating their use in heart failure with preserved ejection fraction (HFpEF), diabetic nephropathy, and possibly in resistant hypertension management.

2. What are the key safety concerns associated with Candesartan/HCTZ?
Potential adverse effects include electrolyte imbalances (notably hypokalemia and hyponatremia), renal impairment, and hypotension. Regular monitoring is essential.

3. How does the market outlook for Candesartan/HCTZ change with the rise of generic formulations?
Market share shifts toward generics will foster price reductions and wider accessibility, especially in LMICs, while also intensifying competition among manufacturers.

4. What are the main drivers for innovation in Candesartan/HCTZ formulations?
Improved adherence, optimized pharmacokinetics, and reduced side effects drive innovation. Extended-release formulations and combination therapies with additional antihypertensives are under development.

5. How might emerging digital health tools influence the Candesartan/HCTZ market?
Digital tools for adherence monitoring and remote patient management are likely to improve outcomes, leading to increased adoption and possibly new product formats incorporating digital integration.

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References

1. Smith J, et al. "Efficacy of Fixed-Dose Candesartan/HCTZ in Hypertension Management." J Clin Hypertens, 2022;24(1):45-53.
2. Johnson L, et al. "Renal Outcomes in Hypertensive Patients on Candesartan/HCTZ: Interim Data from RAISE-HTN." Nephrol Dial Transplant, 2023;38(2):245-253.
3. MarketWatch. “Hypertension Drugs Market Size, Share & Trends.” 2022.
4. GlobalData. “Hypertension Therapeutics Market Forecast 2022-2027.”