Methods Study to Characterize Early Indicators of Weight Loss in People
NCT00383253
Last updated date
ABOUT THIS STUDY
Methods study to characterize early indicators of weight loss in people.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Obesity
Sex
Male
Age
18-55 years
Inclusion Criteria
Show details
- Subjects >=18 years of age with BMI >= 30 and < 40 kg/m2
Exclusion Criteria
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- Females, those with illnesses expected to cause weight loss, those without stable body
weight within 3 months of screening.
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Advanced Information
Descriptive Information | ||||
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Brief Title ICMJE | Methods Study to Characterize Early Indicators of Weight Loss in People | |||
Official Title ICMJE | A Randomized, Open-Label, Parallel Group, Fixed Energy Deficit Methodology Trial to Characterize Early Efficacy Biomarkers During Treatment of Obesity in Adult, Obese, Male Subjects. | |||
Brief Summary | Methods study to characterize early indicators of weight loss in people. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Obesity | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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 | |||
Actual Enrollment ICMJE | 57 | |||
Original Enrollment ICMJE | 48 | |||
Actual Study Completion Date ICMJE | March 2008 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00383253 | |||
Other Study ID Numbers ICMJE | A9001342 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | March 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |