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
  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-Blind
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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: NCT00160498

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

No publications provided

ClinicalTrials.gov Identifier: NCT00160498     History of Changes
Other Study ID Numbers: Ler 25-03
Study First Received: September 8, 2005
Last Updated: March 7, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on October 23, 2014