CLINICAL TRIALS PROFILE FOR ATACAND

All Clinical Trials for Atacand

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00150631 ↗	Danish Hypertension Prevention Project - DHYPP	Unknown status	AstraZeneca	Phase 3	2000-11-01	The present study examine healthy, normotensive subjects 18 to 36 years of age whose both parents have essential hypertension. The subjects receive treatment with either the AT1-antagonist candesartan cilexetil, 16 mg daily or placebo for one year. Then, treatment is withdrawn and the subjects is followed for 10 years to determine if the treatment has been able to either prevent or delay the development of hypertension. The primary objective is to determine whether pharmacological treatment with an angiotensin receptor blocker is able to restrain or delay the progression to hypertension. Secondary objectives are to investigate whether any long-term effect on blood pressure is related to the effect of treatment on renal haemodynamic function, or on the left ventricle mass.
NCT00150631 ↗	Danish Hypertension Prevention Project - DHYPP	Unknown status	University of Aarhus	Phase 3	2000-11-01	The present study examine healthy, normotensive subjects 18 to 36 years of age whose both parents have essential hypertension. The subjects receive treatment with either the AT1-antagonist candesartan cilexetil, 16 mg daily or placebo for one year. Then, treatment is withdrawn and the subjects is followed for 10 years to determine if the treatment has been able to either prevent or delay the development of hypertension. The primary objective is to determine whether pharmacological treatment with an angiotensin receptor blocker is able to restrain or delay the progression to hypertension. Secondary objectives are to investigate whether any long-term effect on blood pressure is related to the effect of treatment on renal haemodynamic function, or on the left ventricle mass.
NCT00150631 ↗	Danish Hypertension Prevention Project - DHYPP	Unknown status	Karin Skov	Phase 3	2000-11-01	The present study examine healthy, normotensive subjects 18 to 36 years of age whose both parents have essential hypertension. The subjects receive treatment with either the AT1-antagonist candesartan cilexetil, 16 mg daily or placebo for one year. Then, treatment is withdrawn and the subjects is followed for 10 years to determine if the treatment has been able to either prevent or delay the development of hypertension. The primary objective is to determine whether pharmacological treatment with an angiotensin receptor blocker is able to restrain or delay the progression to hypertension. Secondary objectives are to investigate whether any long-term effect on blood pressure is related to the effect of treatment on renal haemodynamic function, or on the left ventricle mass.
NCT00227318 ↗	TROPHY - Candesartan Cilexetil Long-term Hypertension Prevention Trial	Completed	AstraZeneca	Phase 3	1998-07-01	The purpose of this study is to determine the effectiveness of candesartan cilexetil in preventing hypertension in people with high normal blood pressure. Patients will be randomized to either Candesartan or placebo for an initial 2-year period followed by a second 2-year period of placebo for all patients.
NCT00242346 ↗	High Doses of Candesartan Cilexetil on the Reduction of Proteinuria	Completed	AstraZeneca	Phase 3	2003-04-01	The purpose of this study is to assess the effects of high doses of candesartan cilexetil and also to assess which dose (16mg, 64mg, 128mg) is the most optimal for the maximum reduction of proteinuria.
NCT00244621 ↗	Atacand Dose Ranging in Hypertensive Pediatric Subjects 1 Year to Less Than 6 Years of Age	Completed	AstraZeneca	Phase 3	2004-11-01	This is a dose ranging study of candesartan cilexetil in hypertensive pediatric subjects ages 1 to less than 6 years of age. It employs a double blind, randomized, dose ranging design intended for conduct as a multicenter trial. There are 3 study 'periods': a 1-week placebo run-in, a 4-week double blind treatment, and a 52-week open-label, long-term treatment period. Subjects undergo a screening evaluation, then a 1-week single-blind, placebo run-in, after which eligible subjects are allocated to receive 1 of 3 dose levels of candesartan cilexetil (0.05 mg/kg, or 0.20 mg /kg or 0.40 mg /kg), liquid formulation, in a 1:1:1 ratio for 4-weeks. At the end of randomized dose allocation (Day 28), blood pressure assessment will be performed and subjects may begin the 52-week, open-label treatment period of the study.

Clinical Trial Conditions for Atacand

Condition Name

Condition Name for Atacand
Intervention	Trials
Hypertension	18
Congestive Heart Failure	4
Heart Failure	3
Type 1 Diabetes	3

Condition MeSH

Condition MeSH for Atacand
Intervention	Trials
Hypertension	18
Heart Failure	7
Diabetic Retinopathy	3
Cognitive Dysfunction	3

Clinical Trial Locations for Atacand

Trials by Country

Trials by Country for Atacand
Location	Trials
United States	68
France	40
Korea, Republic of	17
Canada	8
Denmark	6

Trials by US State

Trials by US State for Atacand
Location	Trials
Texas	6
California	5
Minnesota	3
Michigan	3
Florida	3

Clinical Trial Progress for Atacand

Clinical Trial Phase

Clinical Trial Phase for Atacand
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	17
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Atacand
Clinical Trial Phase	Trials
Completed	34
Unknown status	6
Terminated	3

Clinical Trial Sponsors for Atacand

Sponsor Name

Sponsor Name for Atacand
Sponsor	Trials
AstraZeneca	24
Takeda	5
GlaxoSmithKline	4

Sponsor Type

Sponsor Type for Atacand
Sponsor	Trials
Industry	36
Other	31
NIH	7

ATACAND (Candesartan Cilexetil): Clinical Trials, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction

ATACAND, known generically as candesartan cilexetil, is a selective AT1 subtype angiotensin II receptor antagonist used primarily for managing hypertension in adults and children, as well as heart failure in adults. This article provides an update on the clinical trials, market analysis, and projections for this drug.

Clinical Trials Update

Hypertension and Cognitive Impairment

Several clinical trials have explored the efficacy of candesartan beyond its primary use in hypertension, particularly in the context of cognitive impairment and Alzheimer's disease.

• The Phase 2 AVEC trial compared candesartan with the ACE inhibitor lisinopril and the diuretic hydrochlorothiazide in older people with hypertension and cognitive impairment. The trial found that candesartan-treated patients performed better on certain cognitive tests, such as the Trail Making Test Part B and HVLT, compared to those on lisinopril[1].
• The Phase 2 CEDAR trial, which began in June 2016, tested candesartan’s effects in people with Alzheimer’s disease without high blood pressure. The trial showed that candesartan was safe and did not increase symptoms of hypotension, renal failure, or low serum potassium. It also led to a transient improvement in executive function at six months and increased subcortical network functional connectivity[1].

Alzheimer's Disease

In the context of Alzheimer's disease, candesartan has been investigated for its potential neuroprotective effects.

• Preclinical studies in animal models have shown that candesartan can reduce brain inflammation and amyloid burden. For example, in 5XFAD mice, intranasal candesartan reduced brain inflammation and amyloid burden by increasing Aβ uptake into microglia[1].
• Clinical trials have also explored the impact of candesartan on cerebral microvascular function, finding improved whole-brain cerebrovascular reactivity independent of changes in blood pressure[1].

Pediatric Use

A long-term, open-label extension study (HIP study) is ongoing to characterize the clinical experience of young hypertensive children receiving candesartan cilexetil. This study aims to assess the safety and efficacy of candesartan in pediatric subjects aged 1 to <11 years[4].

Market Analysis

Global Market Size and Growth

The global candesartan cilexetil market size was estimated at USD 584.2 million in 2024. 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[2].

Regional Market Performance

• Asia Pacific: This region holds a significant share of the global market, with a market size of USD 134.37 million in 2024. It is expected to grow at a CAGR of 6.6% from 2024 to 2031. Factors such as rapid urbanization, lifestyle changes, and increasing healthcare expenditure contribute to the rising demand for hypertension medications in this region[2].
• Latin America: The market size in Latin America was USD 29.21 million in 2024, with a projected CAGR of 4.0% from 2024 to 2031[2].
• Middle East and Africa: This region had a market size of USD 11.68 million in 2024, expected to grow at a CAGR of 4.3% from 2024 to 2031[2].

Market Drivers

The growth of the candesartan cilexetil market is driven by several factors:

• Increasing Incidence of Hypertension: Rising awareness about cardiovascular health and the increasing incidence of hypertension are key drivers.
• Advancements in Drug Delivery: Improvements in drug delivery mechanisms and public health campaigns further boost the market.
• Government Initiatives and Healthcare Expenditure: Government initiatives promoting cardiovascular health and increasing healthcare expenditure enhance diagnosis rates and treatment options, driving demand for hypertension medications[2].

Market Projections

Future Outlook

The market for candesartan cilexetil is expected to continue growing due to the increasing global burden of hypertension and the proven efficacy of the drug in managing blood pressure and reducing cardiovascular events.

Competitive Landscape

AstraZeneca, the original developer of Atacand, divested the commercial rights to Cheplapharm in 2021, allowing for broader distribution and marketing of the drug in over 70 countries. This move is expected to further expand the market reach of candesartan cilexetil[5].

Key Takeaways

• Clinical Trials: Candesartan has shown promise in improving cognitive function and reducing amyloid burden in Alzheimer's disease models, with ongoing clinical trials assessing its safety and efficacy.
• Market Size and Growth: The global candesartan cilexetil market is projected to grow significantly, driven by increasing awareness of cardiovascular health and advancements in drug delivery.
• Regional Performance: The Asia Pacific region is the fastest-growing market for candesartan cilexetil, driven by rapid urbanization and lifestyle changes.
• Market Drivers: The market is driven by the increasing incidence of hypertension, public health campaigns, and government initiatives promoting cardiovascular health.

FAQs

What is the primary use of ATACAND (candesartan cilexetil)?

ATACAND is primarily used for managing hypertension in adults and children, as well as heart failure in adults.

What are the findings of the CEDAR trial regarding candesartan and Alzheimer's disease?

The CEDAR trial found that candesartan was safe and led to a transient improvement in executive function at six months, along with increased subcortical network functional connectivity, but did not change brain-wide amyloid PET signals or CSF tau levels[1].

How is the global market for candesartan cilexetil expected to grow?

The global market for candesartan cilexetil is expected to grow at a CAGR of 4.60% from 2024 to 2031, reaching USD 800.4 million by 2031[2].

Which region is the fastest-growing market for candesartan cilexetil?

The Asia Pacific region is the fastest-growing market for candesartan cilexetil, driven by rapid urbanization, lifestyle changes, and increasing healthcare expenditure[2].

Who currently holds the commercial rights to ATACAND?

Cheplapharm currently holds the commercial rights to ATACAND, following the divestment by AstraZeneca in 2021[5].

Sources

1. ALZFORUM: Candesartan.
2. Cognitive Market Research: Global Candesartan Cilexetil Market Report.
3. Exploration Pub: Current therapeutics for Alzheimer's disease and clinical trials.
4. AstraZeneca Clinical Trials: Study to characterize the long-term clinical experience of Atacand in hypertensive pediatric subjects.
5. Drug Discovery Trends: AstraZeneca completes Atacand divestment to Cheplapharm.