Efficacy and Safety Trial to Evaluate the Effect of SCH 497079 on Weight in Obese and Overweight Subjects (Study P05483)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00642993

First received: March 21, 2008

Last updated: September 30, 2009

Last verified: September 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	March 21, 2008
Last Updated Date	September 30, 2009
Start Date ^ICMJE	June 2008
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 21, 2008)	Mean change in body weight from Baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00642993 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 21, 2008)	Percent of responders demonstrating a weight loss ≥5% or ≥10% from Baseline. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Mean change in waist circumference from Baseline. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Mean change in BMI from Baseline. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety Trial to Evaluate the Effect of SCH 497079 on Weight in Obese and Overweight Subjects (Study P05483)(COMPLETED)
Official Title ^ICMJE	A Multicenter, Randomized, Parallel-Group, Placebo-Controlled, Efficacy and Safety Trial to Evaluate the Effect of SCH 497079 on Weight in Obese and Overweight Subjects
Brief Summary	The purpose of this study is to evaluate the effect of SCH 497079 on weight in obese and overweight subjects. The primary measure of effectiveness is the change in body weight during treatment. Additional measures include waist circumference and BMI. In addition, the safety of SCH 497079 in obese and overweight subjects will be evaluated.
Detailed Description	Following Screening, eligible subjects will enroll in a Run-in Period. Subjects who qualify for continuation in the study according to the entry criteria will be randomized to one of two treatment groups (SCH 497079 or placebo in a 2:1 ratio) with stratification according to gender. Baseline measurements for the primary efficacy endpoint, as well as secondary endpoints will be evaluated at the Randomization Visit (Visit 3). Following randomization, subjects will be treated for 12 weeks with double-blind study drug as adjunct to a 500 kcal deficit diet. Subjects will have scheduled visits after the Randomization Visit at 2 to 4 week intervals. Each subject will be encouraged to adhere to medication and dietary instructions.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Obesity Overweight Body Weight
Intervention ^ICMJE	Drug: SCH 497079 administered orally Drug: Placebo Placebo capsules matching SCH 497079 administered orally
Study Arm (s)	Experimental: SCH 497079 SCH 497079 administered orally Intervention: Drug: SCH 497079 Placebo Comparator: Placebo Placebo capsules that will be administered orally. Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	300
Completion Date	January 2009
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: >= 18 years of age, of either sex, and of any race. Obese or overweight subjects. Exclusion Criteria: Subjects who have a history of major eating disorders, GI surgery, active serious cardiovascular, pulmonary, endocrine, neurologic, infectious, gastrointestinal, hepatic, renal, hematologic, immunologic or psychiatric disease or diabetes.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00642993
Other Study ID Numbers ^ICMJE	P05483
Has Data Monitoring Committee	No
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	September 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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