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)
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.
1 other identifier
interventional
676
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 obesity
Started Dec 2008
Shorter than P25 for phase_3 obesity
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2008
CompletedFirst Posted
Study publicly available on registry
November 24, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedResults Posted
Study results publicly available
August 31, 2012
CompletedSeptember 10, 2012
September 1, 2012
1.5 years
November 20, 2008
July 31, 2012
September 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo
VI-0521 Mid
EXPERIMENTAL7.5 mg phentermine and 46 mg topiramate
VI-0521 Top
EXPERIMENTAL15 mg phentermine and 92 mg topiramate
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VIVUS LLClead
- Medpace, Inc.collaborator
Related Publications (2)
Guo F, Garvey WT. Cardiometabolic Disease Staging Predicts Effectiveness of Weight-Loss Therapy to Prevent Type 2 Diabetes: Pooled Results From Phase III Clinical Trials Assessing Phentermine/Topiramate Extended Release. Diabetes Care. 2017 Jul;40(7):856-862. doi: 10.2337/dc17-0088. Epub 2017 Apr 28.
PMID: 28455281DERIVEDGarvey WT, Ryan DH, Look M, Gadde KM, Allison DB, Peterson CA, Schwiers M, Day WW, Bowden CH. Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study. Am J Clin Nutr. 2012 Feb;95(2):297-308. doi: 10.3945/ajcn.111.024927. Epub 2011 Dec 7.
PMID: 22158731DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wesley W Day, PhD
- Organization
- Vivus, Inc
Study Officials
- STUDY DIRECTOR
Craig Peterson
VIVUS LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2008
First Posted
November 24, 2008
Study Start
December 1, 2008
Primary Completion
June 1, 2010
Study Completion
July 1, 2010
Last Updated
September 10, 2012
Results First Posted
August 31, 2012
Record last verified: 2012-09