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

Recordati

Status and phase

Completed

Phase 2

Conditions

Essential Hypertension

Treatments

Drug: Enalapril

Drug: Lercanidipine + Enalapril

Drug: Lercanidipine

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01093807

REC 15/2375-IT-CL 0336

Details and patient eligibility

About

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.

Enrollment

1,039 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

1,039 participants in 9 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Lercanidipine 10 mg

Experimental group

Treatment:

Drug: Lercanidipine

Lercanidipine 20 mg

Experimental group

Treatment:

Drug: Lercanidipine

Enalapril 10 mg

Experimental group

Treatment:

Drug: Enalapril

Enalapril 20 mg

Experimental group

Treatment:

Drug: Enalapril

Lercanidipine 10 mg/Enalapril 10 mg

Experimental group

Treatment:

Drug: Lercanidipine + Enalapril

Lercanidipine 10mg/Enalapril 20 mg

Experimental group

Treatment:

Drug: Lercanidipine + Enalapril

Lercanidipine 20mg/Enalapril 10 mg

Experimental group

Treatment:

Drug: Lercanidipine + Enalapril

Lercanidipine 20mg/Enalapril20mg

Experimental group

Treatment:

Drug: Lercanidipine + Enalapril

Trial contacts and locations

1

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