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

• Sponsor: UCB Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00160498
• Collaborator: (none)
• Enrollment: 180
• Duration (Months): 15

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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 1, 2004
• Actual Primary Completion Date: Aug 1, 2005
• Actual Study Completion Date: Aug 1, 2005

Outcome Measures

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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• 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;

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• UCB Pharma

Investigators

• Study Director: Jürgen Scholze, MD, UCB Pharma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00160498
• Other Study ID Numbers: Ler 25-03
• First Posted: Sep 12, 2005
• Last Update Posted: Mar 10, 2008
• Last Verified: Mar 1, 2008

• Keywords provided by , ,: Lercanidipine, calcium antagonist, hypertension, obesity
• Additional relevant MeSH terms: Hypertension; Lercanidipine

Study Results

No Results Posted as of Mar 10, 2008