Testing the Efficacy of Different Dosages of Lercanidipine to Reduce Hypertensive Blood Pressure in Normal Weight and Obese Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00160498
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : March 10, 2008
Information provided by:
UCB Pharma

Brief Summary:
A double blind study to examine the safety and efficacy of different dosages of lercanidipine in normal weight and obese patients with hypertension

Condition or disease Intervention/treatment Phase
Hypertension Drug: Lercanidipine Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel, Dose-Titration Study to Assess the Efficacy of Lercanidipine 10 mg and 20 mg Once Daily p. o. in Hypertensive Subjects (I or II WHO) With Elevated Body Weight.
Study Start Date : May 2004
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Primary Outcome Measures :
  1. change from baseline of systolic blood pressure (BPs) after 4 weeks of treatment

Secondary Outcome Measures :
  1. Blood pressure, response rate, normalization rate, pulse rate, lipid profile, safety and tolerability. Measures after 4, 8, 12 weeks.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Body Mass Index (BMI): 18.0 - 24.9 or 30.0 - 39.9 kg/m2 (extremes included);
  • Essential hypertension I or II WHO:
  • 140 mmHg ≤ BPs ≤ 179 mmHg and BPd ≤ 109 mmHg at the end of the placebo run-in phase;

Exclusion Criteria:

  • Secondary hypertension;
  • Diabetes mellitus type 1, insulin dependent diabetes mellitus type 2, fasting blood glucose ≥ 160 mg/dl;
  • Subjects keeping to a hypocaloric diet (except special diet for diabetics) to reduce body weight;
  • History or presence of angioneurotic oedema;
  • Subjects developing a hypertensive crisis during wash-out or placebo run-in period;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00160498

Sponsors and Collaborators
UCB Pharma
Study Director: Jürgen Scholze, MD UCB Pharma Identifier: NCT00160498     History of Changes
Other Study ID Numbers: Ler 25-03
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: March 10, 2008
Last Verified: March 2008

Keywords provided by UCB Pharma:
Lercanidipine, calcium antagonist, hypertension, obesity

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action