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

Phase 2

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: Lercanidipine + Enalapril; Drug: Placebo; Drug: Lercanidipine; Drug: Enalapril

• Registration Number: NCT01093807
• Lead Sponsor: RECORDATI GROUP

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-24
• Study First Submitted QC: 2010-03-25
• Study First Posted: 2010-03-26
• Primary Completion: 2011-03
• Status Verified: 2011-04
• Study Completion: 2011-04
• Last Update Submitted: 2011-04-28
• Last Update Posted: 2011-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1039

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Lercanidipine 20mg/Enalapril20mg	Lercanidipine + Enalapril	-
Placebo	Placebo	-
Lercanidipine 10 mg	Lercanidipine	-
Lercanidipine 20 mg	Lercanidipine	-
Lercanidipine 10 mg/Enalapril 10 mg	Lercanidipine + Enalapril	-
Lercanidipine 10mg/Enalapril 20 mg	Lercanidipine + Enalapril	-
Lercanidipine 20mg/Enalapril 10 mg	Lercanidipine + Enalapril	-
Enalapril 10 mg	Enalapril	-
Enalapril 20 mg	Enalapril	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in sitting diastolic blood pressure (SDBP)	after 10 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in sitting systolic blood pressure (SSBP)	after 10 weeks
Safety parameters: adverse events, heart rate, laboratory tests physical examination	10 weeks

Trial Locations

Locations (1)

Hôpital de la Pitié-Salpétrière; 🇫🇷 Paris, France