Avoiding Cardiovascular Events Through Combination Therapy In Patients Living With Systolic Hypertension

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Complete Title of Study

A Prospective, Multinational, Multicenter Trial to Compare the Effects of Amlodipine/Benazepril to Benazepril and Hydrochlorothiazide Combined on the Reduction of Cardiovascular Morbidity and Mortality in Patients With High Risk Hypertension

Study Acronym (The trial's abbreviation if there is one)

ACCOMPLISH

Principal Investigator, Co-investigators, and Collaborating Institutions

Study Chair: Novartis Pharmaceuticals

Overview of Trial

The goal of the ACCOMPLISH trial was to compare the effectiveness of two combination drugs (amlodipine/benazepril and benazepril/HCTZ) on reducing heart disease and death in 11,464 high risk hypertensive patients.

Disease State(s) Studied (e.g. acute MI, breast cancer, etc.)

• Hypertension

Study Phase (e.g. Phase I,II,III,IV) Study Phases are defined here

Phase III

Study Design (e.g. multicenter, randomized, double blind, placebo controlled)

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Arms and How They Were Treated (Intervention) (Explanation here)

Drug: Benazepril/amlodipine

Primary Pre-Specified Endpoint

• Time to having a cardiovascular or neurologic event, including: death from a cardiovascular event, heart attack,
• stroke, hospitalization for chest pain or heart failure, or
• procedure to open a blockage in an arterial blood vessel

Secondary Endpoints

• Time to having a cardiovascular or neurologic event, including: death from a cardiovascular event, heart attack,
• stroke, or hospitalization for heart failure or or
• procedure to open a blockage in an arterial blood vessel
• Risk of developing diabetes
• Progression of kidney disease

Inclusion Criteria

• At least 55 years of age.
• Have elevated blood pressure and at least one other cardiovascular disease or diabetes or evidence of damage to the kidneys, brain, blood vessels or heart as defined in the protocol

Exclusion Criteria

• Allergy to any of the drugs administered in this trial. Selected laboratory tests
• Other protocol-defined exclusion criteria may apply.

Outcome: Primary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)

None reported

Outcome: Secondary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)

None reported

Outcome: Exploratory endpoints (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)

None reported

Outcome: Safety endpoints (Report both relative risk and absolute risk as well as number needed to harm if available)

None reported

Conclusions of the Investigators (Quote the investigators conclusions here)

None reported

Commentary, Discussion and Limitations of the Trial (Anyone can add comments)

None reported

Slides

None reported

Video Commentary

None reported

References (How to insert a reference)

Jamerson K, Weber MA, Bakris GL; et al. (2008). "Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high-risk patients". N. Engl. J. Med. 359 (23): 2417–28. doi:10.1056/NEJMoa0806182. PMID 19052124. CS1 maint: Explicit use of et al. (link) CS1 maint: Multiple names: authors list (link)

External sites for further information (How to insert links)

None reported

Ages

55 years and older

Gender (Indicate whether men, women or both were enrolled)

Both

Accepts Healthy Volunteers (Answer yes or no)

None reported

Enrollment Period (Study start and end date)

Study start date: October 2003

Recruitment Status (explanation)

Completed

Enrollment (Total number of patients enrolled)

11,464

Study Sponsor (e.g. Investigator initiated or company name)

Novartis Pharmaceuticals

Source of Data (Where is this data on this page coming from: publication, principal investigator, or co-investigator)

Novartis

The content of the clinical trial wiki consists of fields that have been suggested by the World Health Organization and wwww.clinicaltrials.gov.