Status:
COMPLETED
A Comparative Study of KES524 in Patients With Obesity Disease
Lead Sponsor:
Eisai Limited
Conditions:
Obesity
Eligibility:
All Genders
20-64 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00165685
Start Date
July 1 2004
End Date
March 1 2007
Last Update
January 29 2010
Active Locations (20)
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1
Chiba, Chiba, Japan, 260-0856
2
Kashiwa, Chiba, Japan, 277-0004
3
Sakura, Chiba, Japan, 285-0841
4
Fukushima, Fukushima, Japan, 960-1247