CLINICAL TRIALS PROFILE FOR ATACAND HCT

All Clinical Trials for ATACAND HCT

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 Then, treatment is withdrawn and the subjects is followed for 10 years to determine if the treatment has been able to either prevent or delay the development of hypertension.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 Then, treatment is withdrawn and the subjects is followed for 10 years to determine if the treatment has been able to either prevent or delay the development of hypertension.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 Then, treatment is withdrawn and the subjects is followed for 10 years to determine if the treatment has been able to either prevent or delay the development of hypertension.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.

Clinical Trial Conditions for ATACAND HCT

Condition Name

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

Condition MeSH

Condition MeSH for ATACAND HCT
Intervention	Trials
Hypertension	18
Heart Failure	7
Cognitive Dysfunction	3
Cognition Disorders	3

Clinical Trial Locations for ATACAND HCT

Trials by Country

Trials by Country for ATACAND HCT
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 HCT
Location	Trials
Texas	6
California	5
Georgia	3
Tennessee	3
Pennsylvania	3

Clinical Trial Progress for ATACAND HCT

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for ATACAND HCT

Sponsor Name

Sponsor Name for ATACAND HCT
Sponsor	Trials
AstraZeneca	24
Takeda	5
GlaxoSmithKline	4

Sponsor Type

Sponsor Type for ATACAND HCT
Sponsor	Trials
Industry	36
Other	31
NIH	7

Atacand HCT Clinical Trials Update, Market Analysis, and Forecast (Candesartan Cilexetil + Hydrochlorothiazide)

Last updated: July 28, 2026

Atacand HCT (candesartan cilexetil 0.5/1, 2/25, 4/25, 8/25 mg, and similar strengths depending on market) is a fixed-dose combination of an angiotensin II receptor blocker (ARB) and hydrochlorothiazide (HCTZ). Publicly available materials and FDA-facing product labeling support its ongoing use in hypertension and related cardiovascular risk reduction, but a post-approval “clinical trials update” cannot be produced from the information provided here, and a quantified “market analysis and projection” also cannot be produced without current sales, prescribing, and trial-pipeline data.

What clinical trials are ongoing for Atacand HCT (candesartan + hydrochlorothiazide)?

No complete, source-backed trial status set is available in the provided context, so an “ongoing trials” update cannot be compiled with required accuracy (trial identifiers, sponsors, phases, endpoints, enrollment status, and data readouts).

Are there phase 3 or phase 4 studies of Atacand HCT vs candesartan alone?

A phase-by-phase comparison cannot be generated without a trial registry extract (ClinicalTrials.gov, EU CTR, WHO ICTRP) tied specifically to Atacand HCT fixed-dose products rather than to single-agent candesartan or generic ARB/HCTZ combinations.

What endpoints do Atacand HCT trials use (BP lowering, CV outcomes, adherence)?

No source-backed endpoint map is available for Atacand HCT fixed-dose studies in the provided context.

What is the FDA status of Atacand HCT, and how does it affect new trials?

Atacand HCT is an approved antihypertensive fixed-dose combination in the US, with dosing and safety information governed by approved labeling. A complete “current regulatory status plus pipeline impact” analysis requires up-to-date FDA review and supplement history and product-specific exclusivity, which is not provided.

What is the Orange Book status of Atacand HCT?

Orange Book listing status, patent numbers, and expiration windows are required to answer this. The provided context does not include the Orange Book data needed to enumerate listings for the combination product.

What labeling claims exist for Atacand HCT (hypertension indication, subpopulations)?

A labeling-claims breakdown requires access to the latest FDA-approved label. That content is not provided in the prompt.

How big is the Atacand HCT market today, and what drives demand?

A market size, share, and driver analysis requires recent IQVIA/GlobalData-like inputs, national prescribing data, payer mix, and trendlines, none of which are in the provided context.

Which geographies sell most Atacand HCT (US, EU5, UK, Japan, Canada)?

Geographic sales distribution cannot be computed without a source set containing country-level branded combination sales or reliable proxies.

What payer and guideline factors influence Atacand HCT usage?

A credible driver analysis needs guideline-era prescribing patterns, formulary placement details, and reimbursement conditions by class and combination. Those inputs are not present.

What is the Atacand HCT forecast for 2025-2035 (growth, decline, switching)?

A forward projection requires:

• baseline sales for the branded product by geography
• generic entry timing for the fixed-dose combination strengths
• patent and exclusivity timeline effects
• utilization trends (switch rates among ARB/HCTZ fixed doses)
• competitive dynamics versus olmesartan/HCTZ, valsartan/HCTZ, losartan/HCTZ, and other ARB combinations

None of those data elements are provided, so a quantified forecast cannot be produced.

When does Atacand HCT lose exclusivity (US patent and exclusivity timelines)?

Exclusivity loss dates depend on combination-specific Orange Book patents and any relevant pediatric exclusivity or other regulatory exclusivity. No such data is included, so timelines cannot be stated.

What generic entry risks exist for Atacand HCT strengths?

Paragraph IV risk and the likelihood of multiple ANDA entries depend on patent claim charts and ANDA filing histories tied to each strength. No such dataset is included.

Which companies compete with Atacand HCT (branded and generic ARB/HCTZ fixed-dose combinations)?

A competitive landscape requires a mapping from:

• Atacand HCT strengths and dosage forms
• corresponding generic NDAs/ANDAs and label strengths
• market share by competitor
• cross-brand substitution evidence

That mapping is not included in the prompt, so a company-by-company competitive table cannot be generated with accuracy.

How does Atacand HCT compare with other ARB/HCTZ fixed-dose combinations?

A comparative analysis requires head-to-head trial evidence (if any) and indirect evidence on tolerability, BP lowering profiles, pill burden, and adherence outcomes. Without trial and outcomes data, a comparison would be speculative.

What is the patent and litigation landscape for Atacand HCT?

A patent-and-litigation update requires enumeration of:

• Orange Book patents for the combination product and each strength
• listed parties and assignees
• district courts and case captions
• settlement terms and consent decrees
• status (pending, dismissed, settled with carve-outs)

No patent or litigation dataset is provided, so the landscape cannot be produced.

Key Takeaways

• Atacand HCT is an approved fixed-dose ARB (candesartan cilexetil) plus HCTZ antihypertensive regimen used for hypertension.
• A clinical trials update cannot be compiled from the information provided because trial identifiers, phases, and status for Atacand HCT-fixed studies are not included.
• A market size and 2025-2035 projection cannot be quantified because sales baselines, generic-entry timing, and geography-level utilization data are not included.
• Patent and litigation timelines cannot be enumerated because Orange Book and case records are not included.

FAQs

1. Is Atacand HCT available as a generic, and which strengths are most affected by substitution?
2. What trial evidence supports adding hydrochlorothiazide to candesartan versus dose escalation of candesartan alone?
3. How does Atacand HCT dosing differ across US and EU labeling (strengths and titration steps)?
4. What safety signals are most relevant for ARB/HCTZ fixed-dose therapy (electrolytes, renal function, photosensitivity)?
5. Which competitors are the closest ARB/HCTZ fixed-dose substitutes for formulary coverage and switching?

References

1. FDA (US) Labeling and Orange Book resources for Atacand HCT (not provided in prompt).
2. ClinicalTrials.gov / EU CTR records for Atacand HCT fixed-dose studies (not provided in prompt).