Avoiding Cardiovascular Events Through COMbination Therapy in Patients Living With Systolic Hypertension: ACCOMPLISH - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00170950

Purpose

A comparison study of two combination drugs, amlodipine/benazepril and benazepril/HCTZ to evaluate the effectiveness of the combination on reducing heart disease and death in a high risk hypertensive population.

Condition	Intervention	Phase
Hypertension	Drug: Benazepril/amlodipine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure High Blood Pressure

Drug Information available for: Benazepril hydrochloride Benazepril Amlodipine Amlodipine besylate Lotrel

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 Outcome Measures:

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

Estimated Enrollment:	11464
Study Start Date:	October 2003

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170950

Locations

United States, New Jersey
Novartis Pharmaceuticals
E. Hanover, New Jersey, United States, 07936

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Jamerson K, Weber MA, Bakris GL, Dahlöf B, Pitt B, Shi V, Hester A, Gupte J, Gatlin M, Velazquez EJ; ACCOMPLISH Trial Investigators. Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high-risk patients. N Engl J Med. 2008 Dec 4;359(23):2417-28.

Study ID Numbers:	CCIB002I2301
Study First Received:	September 10, 2005
Last Updated:	March 20, 2008
ClinicalTrials.gov Identifier:	NCT00170950 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

cardiovascular morbidity
cardiovascular mortality
benazepril
amlodipine
high risk population

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Calcium Channel Blockers
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Protease Inhibitors
Amlodipine
Membrane Transport Modulators
Therapeutic Uses
Benazepril
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on February 09, 2010