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

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: August 23, 2006
Last updated: November 7, 2011
Last verified: August 2006
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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:

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)

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All

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
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Please refer to this study by its identifier: NCT00367978

United States, New Jersey
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Corporation Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Identifier: NCT00367978     History of Changes
Other Study ID Numbers: CCIB002FUS06
Study First Received: August 23, 2006
Last Updated: November 7, 2011

Keywords provided by Novartis:
Hypertension, diabetes, African-American, amlodipine/benazepril

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors processed this record on August 22, 2017