Efficacy and Safety of Lercanidipine and Enalapril in Patients With Essential Hypertension
NCT ID: NCT01093807
Last Updated: 2011-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
1039 participants
INTERVENTIONAL
2010-03-31
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo
once daily for 10 weeks
Lercanidipine 10 mg
Lercanidipine
10 mg once daily for 10 weeks
Lercanidipine 20 mg
Lercanidipine
20 mg once daily for 10 weeks
Enalapril 10 mg
Enalapril
10 mg once daily for 10 weeks
Enalapril 20 mg
Enalapril
20 mg once daily for 10 weeks
Lercanidipine 10 mg/Enalapril 10 mg
Lercanidipine + Enalapril
10/10 mg once daily for 10 weeks
Lercanidipine 10mg/Enalapril 20 mg
Lercanidipine + Enalapril
10/20 mg once daily for 10 weeks
Lercanidipine 20mg/Enalapril 10 mg
Lercanidipine + Enalapril
20/10 mg once daily for 10 weeks
Lercanidipine 20mg/Enalapril20mg
Lercanidipine + Enalapril
20/20 mg once daily for 10 weeks
Interventions
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Placebo
once daily for 10 weeks
Lercanidipine
10 mg once daily for 10 weeks
Lercanidipine
20 mg once daily for 10 weeks
Enalapril
10 mg once daily for 10 weeks
Enalapril
20 mg once daily for 10 weeks
Lercanidipine + Enalapril
10/10 mg once daily for 10 weeks
Lercanidipine + Enalapril
10/20 mg once daily for 10 weeks
Lercanidipine + Enalapril
20/10 mg once daily for 10 weeks
Lercanidipine + Enalapril
20/20 mg once daily for 10 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* History of cerebro- or cardiovascular complications
* Type 1 or Type 2 diabetes on drug treatment
* Severe renal or hepatic insufficiency
18 Years
75 Years
ALL
No
Sponsors
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RECORDATI GROUP
INDUSTRY
Responsible Party
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Medical Department
Principal Investigators
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Giuseppe Mancia, Prof
Role: STUDY_CHAIR
Clinica Medica Ospedale S. Gerardo Università Milano Bicocca Italy
Locations
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Hôpital de la Pitié-Salpétrière
Paris, , France
Countries
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References
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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.
Other Identifiers
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REC 15/2375-IT-CL 0336
Identifier Type: -
Identifier Source: org_study_id