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)

Vivus

Status and phase: Completed; Phase 3

Conditions: Obesity

Treatments: Drug: Placebo; Drug: VI-0521

Study type: Interventional

Funder types: Industry

Identifiers

NCT00796367

OB-305

Details and patient eligibility

About

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).

Enrollment: 676 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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676 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

VI-0521 Mid

Experimental group

Description:

7.5 mg phentermine and 46 mg topiramate

Treatment:

Drug: VI-0521

Drug: VI-0521

VI-0521 Top

Experimental group

Description:

15 mg phentermine and 92 mg topiramate

Treatment:

Drug: VI-0521

Drug: VI-0521