A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults
NCT ID: NCT00600067
Last Updated: 2012-09-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
130 participants
INTERVENTIONAL
2008-01-31
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
Phentermine/Topiramate
phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks
2
Placebo
Oral placebo capsules, once daily, 28 weeks
Interventions
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Phentermine/Topiramate
phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks
Placebo
Oral placebo capsules, once daily, 28 weeks
Eligibility Criteria
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Inclusion Criteria
* If females of child-bearing potential, subjects must be using adequate contraception
* Provide written informed consent
* Be willing and able to comply with scheduled study visits, treatment plan, lab tests and other study procedures
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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Synteract, Inc.
INDUSTRY
Sentrx
INDUSTRY
VIVUS LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Barbara Troupin, MD, MBA
Role: STUDY_DIRECTOR
VIVUS LLC
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Los Angeles, California, United States
Research Site
San Francisco, California, United States
Research Site
Spring Valley, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Bethesda, Maryland, United States
Research Site
Austin, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Richmond, Virginia, United States
Countries
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References
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Garvey WT, Ryan DH, Bohannon NJ, Kushner RF, Rueger M, Dvorak RV, Troupin B. Weight-loss therapy in type 2 diabetes: effects of phentermine and topiramate extended release. Diabetes Care. 2014 Dec;37(12):3309-16. doi: 10.2337/dc14-0930. Epub 2014 Sep 23.
Other Identifiers
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DM-230
Identifier Type: -
Identifier Source: org_study_id