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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01093807

Acronym

FELT

Enrollment

1039

Registered

2010-03-26

Start date

2010-03-31

Completion date

2011-04-30

Last updated

2011-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Keywords

Hypertension, Lercanidipine, Calcium antagonist, Enalapril

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.

Interventions

DRUGPlacebo

once daily for 10 weeks

DRUGLercanidipine

10 mg once daily for 10 weeks

DRUGEnalapril

10 mg once daily for 10 weeks

DRUGLercanidipine + Enalapril

10/10 mg once daily for 10 weeks

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in sitting diastolic blood pressure (SDBP)	after 10 weeks

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026