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

Condition(s) targeted: Hypertension

Intervention: Amlodipine/benazepril (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals Corporation, Study Director, Affiliation: Novartis

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.

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

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

Primary outcome: 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:

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

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): 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

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

Starting date: December 2001
Last updated: August 23, 2006