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

Not Applicable

Completed

• Conditions: Hypertension

• Registration Number: NCT00160498
• Lead Sponsor: UCB Pharma

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-07
• Last Update Posted: 2008-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change from baseline of systolic blood pressure (BPs) after 4 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Blood pressure, response rate, normalization rate, pulse rate, lipid profile, safety and tolerability. Measures after 4, 8, 12 weeks.