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A Comparative Study of KES524 in Patients With Obesity Disease
This study has been completed.
First Received: September 12, 2005   Last Updated: May 8, 2008   History of Changes
Sponsored by: Eisai Limited
Information provided by: Eisai Medical Research 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: 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

Resource links provided by NLM:


Further study details as provided by Eisai Medical Research 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: November 2007
Primary Completion Date: May 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 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
Sponsors and Collaborators
Eisai Limited
Investigators
Study Director: Yutaka Takeuchi Development Clinical Research Dept., Clinical Research Center
  More Information

No publications provided

Study ID Numbers: KES524-J081-161
Study First Received: September 12, 2005
Last Updated: May 8, 2008
ClinicalTrials.gov Identifier: NCT00165685     History of Changes
Health Authority: Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:
Sibutramine
Body Weight
Anti-Obesity Agents
Signs and Symptoms
Obesity
Psychotropic Drugs
Appetite Depressants
Nutrition Disorders
Overweight
Overnutrition
Antidepressive Agents

Additional relevant MeSH terms:
Obesity
Psychotropic Drugs
Overweight
Pharmacologic Actions
Body Weight
Sibutramine
Signs and Symptoms
Anti-Obesity Agents
Therapeutic Uses
Nutrition Disorders
Appetite Depressants
Overnutrition
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on July 02, 2009