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)
Condition: Obesity
MeSH terms: Obesity
Intervention: VI-0521; Placebo; VI-0521
Intervention description: 7.5 mg phentermine and 46 mg topiramate; placebo; 15 mg phentermine and 92 mg topiramate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 676.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Obesity

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 (NCT00553787) at selected study sites. This is an extension study of protocol
      OB-303 (NCT00553787).
    

Eligibility criteria:

        Inclusion Criteria:

        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 Criteria:

        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).