Status:
COMPLETED
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)
Lead Sponsor:
VIVUS LLC
Collaborating Sponsors:
Medpace, Inc.
Conditions:
Obesity
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the long-term safety and efficacy of VI-0521 compared to placebo for the treatment of overweight and obesity in adults who have completed study OB-303 (NCT0055...
Eligibility Criteria
Inclusion
- To be eligible for enrollment into this study, subjects must meet all of the following 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
- Subjects will not be included in the study if they meet any of the following:
- 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).
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
676 Patients enrolled
Trial Details
Trial ID
NCT00796367
Start Date
December 1 2008
End Date
July 1 2010
Last Update
September 10 2012
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