Effects of Amlodipine/Benazepril in the Hypertensive African-American Population With Type 2 Diabetes Mellitus - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00367978

Purpose

This study evaluated the efficacy and safety of amlodipine/benazepril compared with that of enalapril in the treatment of hypertension in African-American patients with type 2 diabetes.

Condition	Intervention	Phase
Hypertension	Drug: Amlodipine/benazepril	Phase IV

MedlinePlus related topics: Diabetes High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Benazepril Benazepril hydrochloride Enalapril Enalapril maleate Enalaprilat

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Multicenter, Study to Determine the Efficacy and Safety of Amlodipine/Benazepril Hydrochloride Versus Enalapril in the Treatment of Hypertension in an African-American Population With Type 2 Diabetes

Further study details as provided by Novartis:

Primary Outcome Measures:

Time from baseline to the achievement of first treatment success (defined as achieving a blood pressure (BP) <130/80 mm Hg). The proportion and cumulative proportion of patients who achieved first treatment success were also determined.

Secondary Outcome Measures:

change from baseline in sitting diastolic BP at Week 24
change from baseline in sitting systolic BP at Week 24
change from baseline in urinary protein excretion at Week 24
change from baseline in HbA1c at Week 24
change from baseline in estimated glomerular filtration rate (EGFR) at Week 24

Estimated Enrollment:	269
Study Start Date:	December 2001

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

African-American
males and females
current diagnosis of type 2 diabetes documented by medical history;
mean sitting diastolic blood pressure of ≥ 90 and ≤ 110 mm Hg;
HbA1C ≤ 9.5%

Exclusion Criteria:

having unilateral or bilateral renal artery stenosis;
having clinically significant cardiac dysrhythmias;
having a significant history of coronary artery disease within the past 6 months;
having a history or diagnosis of congestive heart failure (CHF);
having any clinically relevant cardiac valvular disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367978

Locations

United States, New Jersey
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey, United States, 07936

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals Corporation

Novartis Pharmaceuticals

More Information

Study ID Numbers:	CCIB002FUS06
Study First Received:	August 23, 2006
Last Updated:	August 23, 2006
ClinicalTrials.gov Identifier:	NCT00367978
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Hypertension, diabetes, African-American, amlodipine/benazepril

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Amlodipine
Calcium, Dietary
Enalapril

Enalaprilat
Diabetes Mellitus, Type 2
Benazepril
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder
Hypertension

Additional relevant MeSH terms:

Membrane Transport Modulators
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Calcium Channel Blockers

Enzyme Inhibitors
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009