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)
Information source: VIVUS, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: VI-0521 (Drug); Placebo (Drug); VI-0521 (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: VIVUS, Inc. Official(s) and/or principal investigator(s):
Craig Peterson, Study Director, Affiliation: VIVUS, Inc.
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).
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Percent Weight Change at End of Treatment, Week 108.Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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).
Locations and Contacts
Additional Information
VIVUS company website
Starting date: December 2008
Last updated: September 5, 2012
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