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

This study has been completed.
Sponsor:
Information provided by:
Recordati Industria Chimica e Farmaceutica S.p.A.
ClinicalTrials.gov Identifier:
NCT01093807
First received: March 24, 2010
Last updated: April 28, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Essential Hypertension
Drug: Placebo
Drug: Lercanidipine
Drug: Enalapril
Drug: Lercanidipine + Enalapril
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Recordati Industria Chimica e Farmaceutica S.p.A.:

Primary Outcome Measures:
  • Change from baseline in sitting diastolic blood pressure (SDBP) [ Time Frame: after 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in sitting systolic blood pressure (SSBP) [ Time Frame: after 10 weeks ] [ Designated as safety issue: No ]
  • Safety parameters: adverse events, heart rate, laboratory tests physical examination [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 1039
Study Start Date: March 2010
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
once daily for 10 weeks
Experimental: Lercanidipine 10 mg Drug: Lercanidipine
10 mg once daily for 10 weeks
Experimental: Lercanidipine 20 mg Drug: Lercanidipine
20 mg once daily for 10 weeks
Experimental: Enalapril 10 mg Drug: Enalapril
10 mg once daily for 10 weeks
Experimental: Enalapril 20 mg 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
Experimental: Lercanidipine 10mg/Enalapril 20 mg Drug: Lercanidipine + Enalapril
10/20 mg once daily for 10 weeks
Experimental: Lercanidipine 20mg/Enalapril 10 mg Drug: Lercanidipine + Enalapril
20/10 mg once daily for 10 weeks
Experimental: Lercanidipine 20mg/Enalapril20mg Drug: Lercanidipine + Enalapril
20/20 mg once daily for 10 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093807

Locations
France
Hôpital de la Pitié-Salpétrière
Paris, France
Sponsors and Collaborators
Recordati Industria Chimica e Farmaceutica S.p.A.
Investigators
Study Chair: Giuseppe Mancia, Prof Clinica Medica Ospedale S. Gerardo Università Milano Bicocca Italy
  More Information

No publications provided

Responsible Party: Barbara Bettini - Clinical Project Leader, Medical Department
ClinicalTrials.gov Identifier: NCT01093807     History of Changes
Other Study ID Numbers: REC 15/2375-IT-CL 0336
Study First Received: March 24, 2010
Last Updated: April 28, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica
Germany: Ethics Commission
Ukraine: Ministry of Health
Russia: Ministry of Health of the Russian Federation

Keywords provided by Recordati Industria Chimica e Farmaceutica S.p.A.:
Hypertension
Lercanidipine
Calcium antagonist
Enalapril

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Enalapril
Enalaprilat
Lercanidipine
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Calcium Channel Blockers
Membrane Transport Modulators

ClinicalTrials.gov processed this record on August 18, 2014