- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00165685
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
Intervention / Treatment
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:
- Patients with previously diagnosed type 2 diabetes and HbA1c between ≧6.1% and <9.0% at the start of observation period
- 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- KES524-J081-161
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.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Fundació Sant Joan de DéuNot yet recruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Sibutramine Hydrochloride Monohydrate
-
AbbottCompleted
-
AbbottCompleted
-
Laboratorios Silanes S.A. de C.V.Unknown
-
GlaxoSmithKlineCompleted
-
Merck Sharp & Dohme LLCCompleted
-
AbbottTerminated
-
Mayo ClinicCompletedObesity | OverweightUnited States
-
AbbottCompletedObesity | Binge Eating Disorder
-
AbbottCompleted
-
Mayo ClinicNational Institutes of Health (NIH)CompletedObesityUnited States