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

Novartis275 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

275

Conditions

Hypertension

Interventions

Amlodipine/benazeprilDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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