NCT01093807

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,039

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

April 29, 2011

Status Verified

April 1, 2011

Enrollment Period

1 year

First QC Date

March 24, 2010

Last Update Submit

April 28, 2011

Conditions

Essential Hypertension

Keywords

HypertensionLercanidipineCalcium antagonistEnalapril

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in sitting diastolic blood pressure (SDBP)

    after 10 weeks

Secondary Outcomes (2)

  • Change from baseline in sitting systolic blood pressure (SSBP)

    after 10 weeks

  • Safety parameters: adverse events, heart rate, laboratory tests physical examination

    10 weeks

Study Arms (9)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Lercanidipine 10 mg

EXPERIMENTAL
Drug: Lercanidipine

Lercanidipine 20 mg

EXPERIMENTAL
Drug: Lercanidipine

Enalapril 10 mg

EXPERIMENTAL
Drug: Enalapril

Enalapril 20 mg

EXPERIMENTAL
Drug: Enalapril

Lercanidipine 10 mg/Enalapril 10 mg

EXPERIMENTAL
Drug: Lercanidipine + Enalapril

Lercanidipine 10mg/Enalapril 20 mg

EXPERIMENTAL
Drug: Lercanidipine + Enalapril

Lercanidipine 20mg/Enalapril 10 mg

EXPERIMENTAL
Drug: Lercanidipine + Enalapril

Lercanidipine 20mg/Enalapril20mg

EXPERIMENTAL
Drug: Lercanidipine + Enalapril

Interventions

PlaceboDRUG

once daily for 10 weeks

Placebo
LercanidipineDRUG

10 mg once daily for 10 weeks

Lercanidipine 10 mg
EnalaprilDRUG

10 mg once daily for 10 weeks

Enalapril 10 mg
Lercanidipine + EnalaprilDRUG

10/10 mg once daily for 10 weeks

Lercanidipine 10 mg/Enalapril 10 mg

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Secondary or severe hypertension
  • History of cerebro- or cardiovascular complications
  • Type 1 or Type 2 diabetes on drug treatment
  • Severe renal or hepatic insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de la Pitié-Salpétrière

Paris, France

Location

Related Publications (1)

  • 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.

    PMID: 26630216DERIVED

MeSH Terms

Conditions

Essential HypertensionHypertension

Interventions

lercanidipineEnalapril

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Giuseppe Mancia, Prof

    Clinica Medica Ospedale S. Gerardo Università Milano Bicocca Italy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 24, 2010

First Posted

March 26, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2011

Study Completion

April 1, 2011

Last Updated

April 29, 2011

Record last verified: 2011-04

Locations

FR(1)