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
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.