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

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Placebo
Lercanidipine
Lercanidipine
Enalapril
Enalapril
Lercanidipine + Enalapril
Lercanidipine + Enalapril
Lercanidipine + Enalapril
Lercanidipine + Enalapril
Sponsored by
RECORDATI GROUP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Hypertension, Lercanidipine, Calcium antagonist, Enalapril

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hôpital de la Pitié-Salpétrière

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

Lercanidipine 10 mg

Lercanidipine 20 mg

Enalapril 10 mg

Enalapril 20 mg

Lercanidipine 10 mg/Enalapril 10 mg

Lercanidipine 10mg/Enalapril 20 mg

Lercanidipine 20mg/Enalapril 10 mg

Lercanidipine 20mg/Enalapril20mg

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in sitting diastolic blood pressure (SDBP)

Secondary Outcome Measures

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

Full Information

First Posted
March 24, 2010
Last Updated
April 28, 2011
Sponsor
RECORDATI GROUP
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1. Study Identification

Unique Protocol Identification Number
NCT01093807
Brief Title
Efficacy and Safety of Lercanidipine and Enalapril in Patients With Essential Hypertension
Acronym
FELT
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 Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
RECORDATI GROUP

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Hypertension, Lercanidipine, Calcium antagonist, Enalapril

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1039 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Lercanidipine 10 mg
Arm Type
Experimental
Arm Title
Lercanidipine 20 mg
Arm Type
Experimental
Arm Title
Enalapril 10 mg
Arm Type
Experimental
Arm Title
Enalapril 20 mg
Arm Type
Experimental
Arm Title
Lercanidipine 10 mg/Enalapril 10 mg
Arm Type
Experimental
Arm Title
Lercanidipine 10mg/Enalapril 20 mg
Arm Type
Experimental
Arm Title
Lercanidipine 20mg/Enalapril 10 mg
Arm Type
Experimental
Arm Title
Lercanidipine 20mg/Enalapril20mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
once daily for 10 weeks
Intervention Type
Drug
Intervention Name(s)
Lercanidipine
Intervention Description
10 mg once daily for 10 weeks
Intervention Type
Drug
Intervention Name(s)
Lercanidipine
Intervention Description
20 mg once daily for 10 weeks
Intervention Type
Drug
Intervention Name(s)
Enalapril
Intervention Description
10 mg once daily for 10 weeks
Intervention Type
Drug
Intervention Name(s)
Enalapril
Intervention Description
20 mg once daily for 10 weeks
Intervention Type
Drug
Intervention Name(s)
Lercanidipine + Enalapril
Intervention Description
10/10 mg once daily for 10 weeks
Intervention Type
Drug
Intervention Name(s)
Lercanidipine + Enalapril
Intervention Description
10/20 mg once daily for 10 weeks
Intervention Type
Drug
Intervention Name(s)
Lercanidipine + Enalapril
Intervention Description
20/10 mg once daily for 10 weeks
Intervention Type
Drug
Intervention Name(s)
Lercanidipine + Enalapril
Intervention Description
20/20 mg once daily for 10 weeks
Primary Outcome Measure Information:
Title
Change from baseline in sitting diastolic blood pressure (SDBP)
Time Frame
after 10 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in sitting systolic blood pressure (SSBP)
Time Frame
after 10 weeks
Title
Safety parameters: adverse events, heart rate, laboratory tests physical examination
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Mancia, Prof
Organizational Affiliation
Clinica Medica Ospedale S. Gerardo Università Milano Bicocca Italy
Official's Role
Study Chair
Facility Information:
Facility Name
Hôpital de la Pitié-Salpétrière
City
Paris
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26630216
Citation
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.
Results Reference
derived

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

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