Trials / Completed
CompletedNCT00165685
A Comparative Study of KES524 in Patients With Obesity Disease
A Double-Blind, Placebo-Controlled, Comparative Study of KES524 in Patients With Obesity Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Eisai Limited · Industry
- Sex
- All
- Age
- 20 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
To investigate the efficacy and safety of KES524 in patients with obesity (visceral fat obesity with type 2 diabetes and dyslipidemia), a 52-week, double-blind, placebo-controlled comparative study is conducted. This study aims to examine superiority of KES524 to placebo by employing change and percent change in body weight (primary endpoints) and changes in proportion of subjects achieving ≧ 5% weight reduction, BMI, waist circumference, visceral fat area, subcutaneous fat area, V/S ratio by abdominal CT scan, HbA1c, TG and HDL-C (secondary endpoints).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sibutramine Hydrochloride Monohydrate |
Timeline
- Start date
- 2004-07-01
- Primary completion
- 2007-03-01
- Completion
- 2007-03-01
- First posted
- 2005-09-14
- Last updated
- 2010-01-29
Locations
20 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00165685. Inclusion in this directory is not an endorsement.