Efficacy and Safety of Lercanidipine and Enalapril in Patients With Essential Hypertension

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of various dosage combinations of lercanidipine (10 and 20 mg)and enalapril (10 and 20 mg) in comparison with their respective components and with placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RECORDATI GROUP; Recordati Industria Chimica e Farmaceutica S.p.A.
• Treatments: Enalapril; Enalaprilat; Lercanidipine

Criteria

Inclusion Criteria:

• Office Blood Pressure (BP): Sitting diastolic blood pressure (SDBP)100-109 mmHg (inclusive) and sitting systolic blood pressure (SSBP) < 180 mmHg after a 2 week placebo run-in period

• Home Blood Pressure: diastolic blood pressure (DBP)at home ≥ 85 mmHg in the last week of the placebo run-in period

• Normal Electrocardiogram (ECG), first degree Atrioventricular block or other changes not considered clinically significant

Exclusion Criteria:

• Secondary or severe hypertension

• History of cerebro- or cardiovascular complications

• Type 1 or Type 2 diabetes on drug treatment

• Severe renal or hepatic insufficiency