NCT00160498

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started May 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

March 10, 2008

Status Verified

March 1, 2008

Enrollment Period

1.3 years

First QC Date

September 8, 2005

Last Update Submit

March 7, 2008

Conditions

Hypertension

Keywords

Lercanidipine, calcium antagonist, hypertension, obesity

Outcome Measures

Primary Outcomes (1)

  • change from baseline of systolic blood pressure (BPs) after 4 weeks of treatment

Secondary Outcomes (1)

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

Interventions

LercanidipineDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body Mass Index (BMI): 18.0 - 24.9 or 30.0 - 39.9 kg/m2 (extremes included);
  • Essential hypertension I or II WHO:
  • mmHg ≤ BPs ≤ 179 mmHg and BPd ≤ 109 mmHg at the end of the placebo run-in phase;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionObesity

Interventions

lercanidipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jürgen Scholze, MD

    UCB Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

May 1, 2004

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

March 10, 2008

Record last verified: 2008-03