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

This study has been completed.

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00160498

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

MedlinePlus related topics: High Blood Pressure Obesity

Drug Information available for: Calcium gluconate Lercanidipine Lercanidipine hydrochloride

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
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.

Further study details as provided by UCB:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160498

Sponsors and Collaborators

UCB

Investigators

Study Director:

Jürgen Scholze, MD

UCB

More Information

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

Keywords provided by UCB:

Lercanidipine, calcium antagonist, hypertension, obesity

Study placed in the following topic categories:

Body Weight
Calcium, Dietary
Obesity

Lercanidipine
Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Calcium Channel Blockers

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009