Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I)
NCT01133210
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- obese (body mass index (BMI) between 30 and 45.9)
- increased plasma triglyceride concentrations (150-400 mg/dL)
- active or previous infection with hepatitis B or C
- history of alcohol abuse
- current alcohol consumption (>20g/day)
- severe hypertriglyceridemia (>400 mg/dL)
- active peptic ulcer disease
- diabetes
- pregnant or lactating
- take statins, fibrates, niacin, moderate to strong Cyp3A4 inhibitors or inducers, or
any other medication that might confound interpretation of the study results will be
excluded.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- St. Louis, Missouri
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I) | |||
Official Title ICMJE | Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I) | |||
Brief Summary | The purpose of this study is to determine the effect of maraviroc therapy in obese insulin resistant subjects on:
| |||
Detailed Description | The purpose of this study is to determine, in obese insulin resistant subjects, the effect of maraviroc therapy, a selective antagonist of the human chemokine receptor CCR5, on:
| |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment | |||
Condition ICMJE | Hypertriglyceridemia | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
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 | 27 | |||
Original Estimated Enrollment ICMJE | 44 | |||
Actual Study Completion Date ICMJE | November 2012 | |||
Actual Primary Completion Date | August 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 64 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01133210 | |||
Other Study ID Numbers ICMJE | 10-0533 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Washington University School of Medicine | |||
Study Sponsor ICMJE | Washington University School of Medicine | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | Washington University School of Medicine | |||
Verification Date | December 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |