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”

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.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: Amlodipine/benazepril

Primary 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 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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Corporation Study Director Novartis  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00367978

Study ID Number: CCIB002FUS06

ClinicalTrials.gov Identifier: NCT00367978

Health Authority: United States: Food and Drug Administration