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

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

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.

Study Overview

• Status: Completed
• Conditions: Essential Hypertension
• Intervention / Treatment: Drug: Placebo; Drug: Lercanidipine; Drug: Lercanidipine; Drug: Enalapril; Drug: Enalapril; Drug: Lercanidipine + Enalapril; Drug: Lercanidipine + Enalapril; Drug: Lercanidipine + Enalapril; Drug: Lercanidipine + Enalapril

• Study Type: Interventional
• Enrollment (Actual): 1039
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Hôpital de la Pitié-Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

9

Arms and Interventions

Participant Group / 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; Drug: Lercanidipine; 20 mg once daily for 10 weeks
Experimental: Lercanidipine 20 mg	Drug: Lercanidipine; 10 mg once daily for 10 weeks; Drug: Lercanidipine; 20 mg once daily for 10 weeks
Experimental: Enalapril 10 mg	Drug: Enalapril; 10 mg once daily for 10 weeks; Drug: Enalapril; 20 mg once daily for 10 weeks
Experimental: Enalapril 20 mg	Drug: Enalapril; 10 mg once daily for 10 weeks; 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; Drug: Lercanidipine + Enalapril; 10/20 mg once daily for 10 weeks; Drug: Lercanidipine + Enalapril; 20/10 mg once daily for 10 weeks; Drug: Lercanidipine + Enalapril; 20/20 mg once daily for 10 weeks
Experimental: Lercanidipine 10mg/Enalapril 20 mg	Drug: Lercanidipine + Enalapril; 10/10 mg once daily for 10 weeks; Drug: Lercanidipine + Enalapril; 10/20 mg once daily for 10 weeks; Drug: Lercanidipine + Enalapril; 20/10 mg once daily for 10 weeks; Drug: Lercanidipine + Enalapril; 20/20 mg once daily for 10 weeks
Experimental: Lercanidipine 20mg/Enalapril 10 mg	Drug: Lercanidipine + Enalapril; 10/10 mg once daily for 10 weeks; Drug: Lercanidipine + Enalapril; 10/20 mg once daily for 10 weeks; Drug: Lercanidipine + Enalapril; 20/10 mg once daily for 10 weeks; Drug: Lercanidipine + Enalapril; 20/20 mg once daily for 10 weeks
Experimental: Lercanidipine 20mg/Enalapril20mg	Drug: Lercanidipine + Enalapril; 10/10 mg once daily for 10 weeks; Drug: Lercanidipine + Enalapril; 10/20 mg once daily for 10 weeks; Drug: Lercanidipine + Enalapril; 20/10 mg once daily for 10 weeks; Drug: Lercanidipine + Enalapril; 20/20 mg once daily for 10 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: RECORDATI GROUP
• Investigators: Study Chair: Giuseppe Mancia, Prof, Clinica Medica Ospedale S. Gerardo Università Milano Bicocca Italy

Publications and helpful links

General Publications

• Mancia G, Omboni S, Chazova I, Coca A, Girerd X, Haller H, Parati G, Pauletto P, Pupek-Musialik D, Svyshchenko Y; FELT Study Group. Effects of the lercanidipine-enalapril combination vs. the corresponding monotherapies on home blood pressure in hypertension: evidence from a large database. J Hypertens. 2016 Jan;34(1):139-48. doi: 10.1097/HJH.0000000000000767.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: March 24, 2010
• First Submitted That Met QC Criteria: March 25, 2010
• First Posted (Estimate): March 26, 2010

Study Record Updates

• Last Update Posted (Estimate): April 29, 2011
• Last Update Submitted That Met QC Criteria: April 28, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Hypertension; Enalapril; Lercanidipine; Calcium antagonist
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin-Converting Enzyme Inhibitors; Enalaprilat; Enalapril; Lercanidipine
• Other Study ID Numbers: REC 15/2375-IT-CL 0336