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

Novartis

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: amlodipine besylate/benazepril hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00136851

CCIB002FUS19

Details and patient eligibility

About

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.

Enrollment: 259 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind