Hypertension
Conditions
Keywords
amlodipine, benazepril, hypertension, diastolic
Brief summary
Comparison of the safety and efficacy of the combination of amlodipine/Benazepril to amlodipine monotherapy in patients with non-essential hypertension, not controlled on amlodipine alone.
Interventions
Sponsors
Pfizer
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Outpatients 18 years of age or older. * Male or female patients are eligible. Female patients must be either post-menopausal for one year or surgically sterile, or using effective, contraceptive methods such as barrier method with spermicide, or an intrauterine device. * Patients with essential hypertension as measured by a validated device
Exclusion criteria
* Severe hypertension (DBP \> 115 mmHg diastolic and/or SBP \> 180 mmHg systolic). Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in mean sitting diastolic blood pressure at week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in mean sitting systolic blood pressure at week 6 | — |
| Change from week 2 in mean sitting diastolic and systolic blood pressure at week 6 | — |
| Diastolic response rate at week 6. Patients were considered responders if they had a mean sitting diastolic blood pressure of < 90 mmHg or a >= 10 mm Hg decrease compared to baseline. | — |
| Change from baseline in 24 hour diastolic and systolic blood pressure at week 6 | — |
| Change from baseline in 24 hour diastolic and systolic blood pressure at peak which is defined as the lowest hourly blood pressure mean and the average of the hourly means from 4 to 6 hours post dose at week 6 | — |
Countries
United States
Outcome results
None listed