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Completed

NCT Number: NCT01093807

Efficacy and Safety of Lercanidipine and Enalapril 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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital de la Pitié-Salpétrière

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

once daily for 10 weeks

Lercanidipine

Drug

10 mg once daily for 10 weeks

Enalapril

Drug

10 mg once daily for 10 weeks

Lercanidipine + Enalapril

Drug

10/10 mg once daily for 10 weeks

Primary outcomes

  1. Change from baseline in sitting diastolic blood pressure (SDBP)

    Time frame: after 10 weeks

Secondary outcomes

  1. Change from baseline in sitting systolic blood pressure (SSBP)

    Time frame: after 10 weeks

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

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

RECORDATI GROUP

Industry

Registry information

Official study 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

Acronym: FELT

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 26, 2010
Registry last updated
Apr 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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