Hypertension
Conditions
Keywords
Hypertension, diabetes, African-American, amlodipine/benazepril
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.
Interventions
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed