Effects of Amlodipine/Benazepril in the Hypertensive African-American Population With Type 2 Diabetes Mellitus
Phase 4
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00367978
- Lead Sponsor
- Novartis
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 275
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%
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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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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Novartis Pharmaceuticals Corporation
🇺🇸East Hanover, New Jersey, United States