|
|
|
|
|
|
Sponsored by: |
Eisai Limited |
Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00165685 |
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).
Condition | Intervention | Phase |
Obesity |
Drug: Sibutramine Hydrochloride Monohydrate |
Phase III |
MedlinePlus related topics: | Obesity |
Drug Information available for: | Sibutramine Sibutramine hydrochloride monohydrate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled, Comparative Study of KES524 in Patients With Obesity Disease |
Study Start Date: | July 2004 |
Study Completion Date: | November 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 20 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with the following two health impairments:
Exclusion Criteria:
Japan, Chiba Prefecture | |||||
Chiba, Chiba Prefecture, Japan, 260-0856 | |||||
Kashiwa, Chiba Prefecture, Japan, 277-0004 | |||||
Sakura, Chiba Prefecture, Japan, 285-0841 | |||||
Japan, Fukushima Prefecture | |||||
Fukushima, Fukushima Prefecture, Japan, 960-1247 | |||||
Koriyama, Fukushima Prefecture, Japan, 963-8022 | |||||
Japan, Gunma Prefecture | |||||
Maebashi, Gunma Prefecture, Japan, 371-0034 | |||||
Japan, Ibaraki Prefecture | |||||
Tsuchiura, Ibaraki Prefecture, Japan, 300-0053 | |||||
Hitachiota, Ibaraki Prefecture, Japan, 313-0014 | |||||
Tsukuba, Ibaraki Prefecture, Japan, 305-0005 | |||||
Mito, Ibaraki Prefecture, Japan, 311-4153 | |||||
Naka, Ibaraki Prefecture, Japan, 311-0113 | |||||
Japan, Miyagi Prefecture | |||||
Sendai, Miyagi Prefecture, Japan, 980-0011 | |||||
Sendai, Miyagi Prefecture, Japan, 980-0872 | |||||
Japan, Tokyo | |||||
Itabashi-ku, Tokyo, Japan, 173-0032 | |||||
Shibuya-ku, Tokyo, Japan, 150-0012 | |||||
Hachioji, Tokyo, Japan, 193-0944 | |||||
Chiyoda-ku, Tokyo, Japan, 101-0062 | |||||
Chiyoda-ku, Tokyo, Japan, 102-0071 | |||||
Minato-ku, Tokyo, Japan, 105-0003 | |||||
Chuo-ku, Tokyo, Japan, 103-0026 |
Eisai Limited |
Study Director: | Yutaka Takeuchi | Development Clinical Research Dept., Clinical Research Center |
Study ID Numbers: | KES524-J081-161 |
First Received: | September 12, 2005 |
Last Updated: | May 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00165685 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
|
|
|