A Comparative Study of KES524 in Patients With Obesity Disease

January 28, 2010 updated by: Eisai Limited

A Double-Blind, Placebo-Controlled, Comparative Study of KES524 in Patients With Obesity Disease

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).

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Chiba Prefecture
      • Chiba, Chiba Prefecture, Japan, 260-0856
      • Kashiwa, Chiba Prefecture, Japan, 277-0004
      • Sakura, Chiba Prefecture, Japan, 285-0841
    • Fukushima Prefecture
      • Fukushima, Fukushima Prefecture, Japan, 960-1247
      • Koriyama, Fukushima Prefecture, Japan, 963-8022
    • Gunma Prefecture
      • Maebashi, Gunma Prefecture, Japan, 371-0034
    • Ibaraki Prefecture
      • 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
    • Miyagi Prefecture
      • Sendai, Miyagi Prefecture, Japan, 980-0011
      • Sendai, Miyagi Prefecture, Japan, 980-0872
    • Tokyo
      • Chiyoda-ku, Tokyo, Japan, 101-0062
      • Chiyoda-ku, Tokyo, Japan, 102-0071
      • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change and percent change in body weight

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Yutaka Takeuchi, Development Clinical Research Dept., Clinical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

January 29, 2010

Last Update Submitted That Met QC Criteria

January 28, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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