A Safety and Efficacy Study of VI-0521 to Evaluate the Long Term Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions. An Extension Study of Protocol OB-303 (NCT00553787)
NCT ID: NCT00796367
Last Updated: 2012-09-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
676 participants
INTERVENTIONAL
2008-12-31
2010-07-31
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
DOUBLE
Study Groups
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Placebo
Placebo
Placebo
placebo
VI-0521 Mid
7.5 mg phentermine and 46 mg topiramate
VI-0521
7.5 mg phentermine and 46 mg topiramate
VI-0521 Top
15 mg phentermine and 92 mg topiramate
VI-0521
15 mg phentermine and 92 mg topiramate
Interventions
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VI-0521
7.5 mg phentermine and 46 mg topiramate
Placebo
placebo
VI-0521
15 mg phentermine and 92 mg topiramate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Completion of study OB-303 (NCT00553787) on treatment and compliance with all protocol requirements
* Written informed consent
* Female subjects of childbearing potential must be using adequate contraception, defined as double-barrier methods, stable hormonal contraception plus single barrier method, or tubal ligation. Female subjects are considered to be of childbearing potential unless they have undergone a hysterectomy or bilateral oophorectomy, are ≥55 years of age and experienced spontaneous cessation of menses for at least 1 year, or have a documented follicle-stimulating hormone level ≥40 IU/L
* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria
* Body mass index ≤22 kg/m2 at the completion of study OB-303
* Off study medication at completion of study OB-303 (NCT00553787) for longer than 4 weeks continuously due to an event-driven holiday, or off study medication with no plans to restart
* Development of any condition during study OB-303 (NCT00553787) that, in the opinion of the investigator, would contraindicate the administration of study medication, affect compliance, interfere with study evaluations, or confound the interpretation of study results
* Participation in a formal weight loss program (including: Weight Watchers and related dietary/lifestyle intervention programs; prepared food programs; prescribed or over the counter weight loss medications; dietary supplement or herbal preparations, teas, or tinctures intended for weight loss; or any supervised fast or very low calorie diet).
18 Years
70 Years
ALL
No
Sponsors
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Medpace, Inc.
INDUSTRY
VIVUS LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Craig Peterson
Role: STUDY_DIRECTOR
VIVUS LLC
References
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Guo F, Garvey WT. Cardiometabolic Disease Staging Predicts Effectiveness of Weight-Loss Therapy to Prevent Type 2 Diabetes: Pooled Results From Phase III Clinical Trials Assessing Phentermine/Topiramate Extended Release. Diabetes Care. 2017 Jul;40(7):856-862. doi: 10.2337/dc17-0088. Epub 2017 Apr 28.
Garvey WT, Ryan DH, Look M, Gadde KM, Allison DB, Peterson CA, Schwiers M, Day WW, Bowden CH. Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study. Am J Clin Nutr. 2012 Feb;95(2):297-308. doi: 10.3945/ajcn.111.024927. Epub 2011 Dec 7.
Related Links
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VIVUS company website
Other Identifiers
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OB-305
Identifier Type: -
Identifier Source: org_study_id