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:
Information provided by:
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00160498
First received: September 8, 2005
Last updated: March 7, 2008
Last verified: March 2008

September 8, 2005
March 7, 2008
May 2004
August 2005   (final data collection date for primary outcome measure)
change from baseline of systolic blood pressure (BPs) after 4 weeks of treatment
Same as current
Complete list of historical versions of study NCT00160498 on ClinicalTrials.gov Archive Site
Blood pressure, response rate, normalization rate, pulse rate, lipid profile, safety and tolerability. Measures after 4, 8, 12 weeks.
Same as current
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Testing the Efficacy of Different Dosages of Lercanidipine to Reduce Hypertensive Blood Pressure in Normal Weight and Obese Patients
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.

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

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Hypertension
Drug: Lercanidipine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
August 2005
August 2005   (final data collection date for primary outcome measure)

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;
Both
18 Years to 75 Years
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Contact information is only displayed when the study is recruiting subjects
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NCT00160498
Ler 25-03
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UCB Pharma
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Study Director: Jürgen Scholze, MD UCB Pharma
UCB Pharma
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP