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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00160498

Enrollment

180

Registered

2005-09-12

Start date

2004-05-31

Completion date

2005-08-31

Last updated

2008-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Lercanidipine, calcium antagonist, hypertension, obesity

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

Interventions

DRUGLercanidipine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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;

Design outcomes

Primary

Measure	Time frame
change from baseline of systolic blood pressure (BPs) after 4 weeks of treatment	—

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026