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

Sponsor

RECORDATI GROUP (Industry)

Overall Status

Completed

CT.gov ID

NCT01093807

Collaborator

(none)

1,039

Enrollment

Location

Arms

Duration (Months)

79.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension	Drug: Placebo Drug: Lercanidipine Drug: Lercanidipine Drug: Enalapril Drug: Enalapril Drug: Lercanidipine + Enalapril Drug: Lercanidipine + Enalapril Drug: Lercanidipine + Enalapril Drug: Lercanidipine + Enalapril	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

1039 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Randomized, Parallel Group, Double-blind Trial to Evaluate Different Dose Combinations of Lercanidipine and Enalapril in Comparison With Each Component Administered Alone and With Placebo in Patients With Essential Hypertension

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo once daily for 10 weeks
Experimental: Lercanidipine 10 mg	Drug: Lercanidipine 10 mg once daily for 10 weeks
Experimental: Lercanidipine 20 mg	Drug: Lercanidipine 20 mg once daily for 10 weeks
Experimental: Enalapril 10 mg	Drug: Enalapril 10 mg once daily for 10 weeks
Experimental: Enalapril 20 mg	Drug: Enalapril 20 mg once daily for 10 weeks
Experimental: Lercanidipine 10 mg/Enalapril 10 mg	Drug: Lercanidipine + Enalapril 10/10 mg once daily for 10 weeks
Experimental: Lercanidipine 10mg/Enalapril 20 mg	Drug: Lercanidipine + Enalapril 10/20 mg once daily for 10 weeks
Experimental: Lercanidipine 20mg/Enalapril 10 mg	Drug: Lercanidipine + Enalapril 20/10 mg once daily for 10 weeks
Experimental: Lercanidipine 20mg/Enalapril20mg	Drug: Lercanidipine + Enalapril 20/20 mg once daily for 10 weeks

Outcome Measures

Primary Outcome Measures

Change from baseline in sitting diastolic blood pressure (SDBP) [after 10 weeks]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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