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)

Phase 3

Completed

• Conditions: Obesity
• Interventions: Drug: VI-0521; Drug: Placebo

• Registration Number: NCT00796367
• Lead Sponsor: VIVUS LLC

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-20
• Study First Submitted QC: 2008-11-21
• Study First Posted: 2008-11-24
• Study Start: 2008-12
• Primary Completion: 2010-06
• Study Completion: 2010-07
• Disposition First Submitted: 2011-05-13
• Disposition First Submitted QC: 2011-05-13
• Disposition First Posted: 2011-05-18
• Results First Submitted: 2012-07-31
• Results First Submitted QC: 2012-07-31
• Results First Posted: 2012-08-31
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-05
• Last Update Posted: 2012-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 676

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VI-0521 Mid	VI-0521	7.5 mg phentermine and 46 mg topiramate
VI-0521 Top	VI-0521	15 mg phentermine and 92 mg topiramate
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Percent Weight Change at End of Treatment, Week 108.	From baseline to end of treatment
Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108.	Baseline to End of Treatment