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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00160498
First Posted: September 12, 2005
Last Update Posted: March 10, 2008
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.
Information provided by:
UCB Pharma
  Purpose
A double blind study to examine the safety and efficacy of different dosages of lercanidipine in normal weight and obese patients with hypertension

Condition Intervention
Hypertension Drug: Lercanidipine

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

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

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

Estimated Enrollment: 180
Study Start Date: May 2004
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
  Eligibility

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
Criteria

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;
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00160498


Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: Jürgen Scholze, MD UCB Pharma
  More Information

ClinicalTrials.gov Identifier: NCT00160498     History of Changes
Other Study ID Numbers: Ler 25-03
First Submitted: September 8, 2005
First Posted: September 12, 2005
Last Update Posted: March 10, 2008
Last Verified: March 2008

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

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