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

Sponsor:	Novartis
Information provided by (Responsible Party):	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2 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 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

Enrollment:	275
Study Start Date:	December 2001
Study Completion Date:	September 2003
Primary Completion Date:	September 2003 (Final data collection date for primary outcome measure)

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

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00367978 History of Changes
Other Study ID Numbers:	CCIB002FUS06
Study First Received:	August 23, 2006
Last Updated:	November 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Hypertension, diabetes, African-American, amlodipine/benazepril

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Benazepril
Calcium Channel Blockers

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012