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

Novartis1,422 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,422

Conditions

Hypertension

Interventions

amlodipine/benazeprilDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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