A Study Comparing the Response of Patients With Hypertension to Amlodipine or Amlodipine Plus Benazepril.

Condition(s) targeted: Hypertension

Intervention: amlodipine/benazepril (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis

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.

Official title: A Multicenter, Group Study to Evaluate the Safety and Efficacy of Amlodipine and Benazepril Administered in Combination Compared to Amlodipine Monotherapy in Hypertensive Patients Not Adequately Controlled With Amlodipine Alone

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in mean sitting diastolic blood pressure at week 6

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 exclusion criteria may apply.

Novartis Pharmaceuticals, E. Hanover, New Jersey 07936, United States

Starting date: July 2004
Last updated: March 20, 2008