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)

Study Overview
=================
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).

Official Title
-----------------
A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Extension Study (From Study OB-303 [NCT00553787]) to Determine the Safety and Efficacy Of VI-0521 for the Long-Term Treatment Of Obesity in Adults With Obesity-Related Co-Morbid Conditions.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: VI-0521
* Drug: Placebo
* Drug: VI-0521


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* placebo<br>|
| Experimental: VI-0521 Mid<br>7.5 mg phentermine and 46 mg topiramate | Drug: VI-0521<br>* 7.5 mg phentermine and 46 mg topiramate<br>* Other names: PHEN/TPM;|
| Experimental: VI-0521 Top<br>15 mg phentermine and 92 mg topiramate | Drug: VI-0521<br>* 15 mg phentermine and 92 mg topiramate<br>* Other names: PHEN/TPM;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity