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A Comparative Study of KES524 in Patients With Obesity Disease

NCT00165685 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2010-01-29

No results posted yet for this study

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

DRUG

Sibutramine Hydrochloride Monohydrate

Sponsors & Collaborators

  • Eisai Limited

    lead INDUSTRY

Principal Investigators

  • Yutaka Takeuchi · Development Clinical Research Dept., Clinical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2007-03-31
Completion
2007-03-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00165685 on ClinicalTrials.gov