Study Comparing the Efficacy of Amlodipine Besylate/Benazepril Versus Amlodipine in the Treatment of Severe Hypertension

Novartis Pharmaceuticals259 enrolled

Overview

This trial is designed to study the efficacy of an amlodipine besylate/benazepril treatment regimen versus an amlodipine treatment regimen in the treatment of severe hypertension.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

259

Conditions

Hypertension

Interventions

amlodipine besylate/benazepril hydrochlorideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of severe hypertension Exclusion Criteria: * Diastolic blood pressure (DBP) \< 60 mm Hg * Serum potassium \< 3.5 or \> 5.5 mEq/L in the absence of all potassium supplements * Refractory hypertension defined as systolic blood pressure (SBP) ≥ 180 mmHg and/or DBP ≥ 110 mmHg and unresponsive to triple-drug regimens Other protocol-defined exclusion criteria may apply.

Locations (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Percentage of subjects achieving blood pressure goal which is defined as < 140/90 mm Hg, or < 130/80 mm Hg in subjects with diabetes after 4 weeks

Secondary Outcomes

Percentage of subjects achieving blood pressure goal, defined as < 140/90 mm Hg, or < 130/80 mm Hg in subjects with diabetes after 6 weeks

Change from baseline in the mean sitting systolic blood pressure after 4 and 6 weeks

Change from baseline in the mean sitting diastolic blood pressure after 4 and 6 weeks

Percentage of subjects with swelling in legs or arms after 4 and 6 weeks

Data from ClinicalTrials.gov

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