A Comparative Study of KES524 in Patients With Obesity Disease - Full Text View

Sponsor:	Eisai Limited
Information provided by:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00165685

Purpose

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Double-Blind, Placebo-Controlled, Comparative Study of KES524 in Patients With Obesity Disease

Resource links provided by NLM:

MedlinePlus related topics: Obesity

Drug Information available for: Sibutramine Sibutramine hydrochloride monohydrate

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

Change and percent change in body weight

Secondary Outcome Measures:

Proportion of subjects achieving ≧5% weight reduction
Change in BMI
Change in waist circumference
Change in visceral fat area, subcutaneous fat area, and V/S ratio by abdominal CT scan
Change in HbA1c
Change and percent change in fasting serum lipids (TG, HDL-C)

Study Start Date:	July 2004
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	20 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with ≧25 kg/m2 of BMI at the start of the observation period
Patients with visceral fat area ≧100 cm2 measured with abdominal CT scan
Patients with the following two health impairments:
1. Patients with previously diagnosed type 2 diabetes and HbA1c between ≧6.1% and <9.0% at the start of observation period
2. Patients with ≧150 mg/dL of triglyceride (TG), and/or <40 mg/dL of high-density lipoprotein cholesterol (HDL-C) for serum lipid parameters as dyslipidemic index at the start of the observation period
Patients continuously receiving diet therapy for 8 weeks or longer before the start of the observation period
Patients not receiving antidiabetic (12 weeks), antihyperlipidemics (4 weeks) and/or antihypertensive (4 weeks) drugs. If used, those who have received a consistent dosage and administration beginning more than 4 weeks (more than 12 weeks for antidiabetics) before the start of the observation period
Patients with ambulatory treatment aged between ≧20 years and <65 years at the time of obtaining informed consent
Patients who are given full explanation about the study objective and contents and can give written informed consent

Exclusion Criteria:

Patients with pulse rate of ≧100/min during the observation period
Patients with systolic blood pressure of ≧160 mmHg and/or with diastolic blood pressure of ≧100 mmHg during the observation period
Patients with body weight loss of ≧3% as compared to that at the start of the observation period, or body mass index (BMI) that is reduced to <25 kg/m2 during the observation period
Patients who have received insulin within 12 weeks before the start of the observation period
Patients with present illness or past history of severe eating disorder (e.g., anorexia nervosa or bulimia nervosa)
Patients with present illness or past history of drug allergy or severe allergic disease(s)
Patients with present illness or past history of the following disorders:
Coronary artery disease (myocardial infarction, angina), heart failure
Serious diseases such as cardiovascular (severe tachycardiac heart failure), renal (renal failure), hepatic (severe hepatitis, cirrhosis), pancreatic (severe pancreatitis), psychotic (severe depression, schizophrenia, alcohol addict, drug addict) disorders
Pregnant or lactating women, or women who intend to become pregnant during the study period
Patients who previously participated in and were treated in another clinical study of KES524
Patients who have received another study drug within 24 weeks before starting observation period of this study
Patients who are judged to be ineligible for study entry by the investigator or subinvestigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165685

Locations

Japan

Chiba, Chiba Prefecture, Japan, 260-0856

Kashiwa, Chiba Prefecture, Japan, 277-0004

Sakura, Chiba Prefecture, Japan, 285-0841

Fukushima, Fukushima Prefecture, Japan, 960-1247

Koriyama, Fukushima Prefecture, Japan, 963-8022

Maebashi, Gunma Prefecture, Japan, 371-0034

Hitachiota, Ibaraki Prefecture, Japan, 313-0014

Mito, Ibaraki Prefecture, Japan, 311-4153

Naka, Ibaraki Prefecture, Japan, 311-0113

Tsuchiura, Ibaraki Prefecture, Japan, 300-0053

Tsukuba, Ibaraki Prefecture, Japan, 305-0005

Sendai, Miyagi Prefecture, Japan, 980-0011

Sendai, Miyagi Prefecture, Japan, 980-0872

Chiyoda-ku, Tokyo, Japan, 102-0071

Chiyoda-ku, Tokyo, Japan, 101-0062

Chuo-ku, Tokyo, Japan, 103-0026

Hachioji, Tokyo, Japan, 193-0944

Itabashi-ku, Tokyo, Japan, 173-0032

Minato-ku, Tokyo, Japan, 105-0003

Shibuya-ku, Tokyo, Japan, 150-0012

Sponsors and Collaborators

Eisai Limited

Investigators

Study Director:

Yutaka Takeuchi

Development Clinical Research Dept., Clinical Research Center

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00165685 History of Changes
Other Study ID Numbers:	KES524-J081-161
Study First Received:	September 12, 2005
Last Updated:	January 28, 2010
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Sibutramine

Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 13, 2012