Status:
COMPLETED
Effects of Amlodipine/Benazepril in the Hypertensive African-American Population With Type 2 Diabetes Mellitus
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2003
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT00367978
Start Date
December 1 2001
End Date
September 1 2003
Last Update
November 8 2011
Active Locations (1)
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1
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey, United States, 07936