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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)

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ClinicalTrials.gov Identifier: NCT00796367
Recruitment Status : Completed
First Posted : November 24, 2008
Results First Posted : August 31, 2012
Last Update Posted : September 10, 2012
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
VIVUS LLC

Tracking Information
First Submitted Date  ICMJE November 20, 2008
First Posted Date  ICMJE November 24, 2008
Results First Submitted Date  ICMJE July 31, 2012
Results First Posted Date  ICMJE August 31, 2012
Last Update Posted Date September 10, 2012
Study Start Date  ICMJE December 2008
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2012)
  • Percent Weight Change at End of Treatment, Week 108. [ Time Frame: From baseline to end of treatment ]
  • Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108. [ Time Frame: Baseline to End of Treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2008)
The primary efficacy endpoints are weight loss and percent weight loss from the start of treatment in study OB-303 at monthly time points during the second year of treatment. [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2008)
Percentages of subjects who achieve reductions in total body weight from study OB-303. Change from study OB-303 baseline in waist circumference. [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Drug: VI-0521
    7.5 mg phentermine and 46 mg topiramate
    Other Names:
    • Qsymia
    • Qnexa
    • PHEN/TPM
  • Drug: Placebo
    placebo
  • Drug: VI-0521
    15 mg phentermine and 92 mg topiramate
    Other Names:
    • Qsymia
    • Qnexa
    • PHEN/TPM
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: VI-0521 Mid
    7.5 mg phentermine and 46 mg topiramate
    Intervention: Drug: VI-0521
  • Experimental: VI-0521 Top
    15 mg phentermine and 92 mg topiramate
    Intervention: Drug: VI-0521
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2011)
676
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2008)
1000
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00796367
Other Study ID Numbers  ICMJE OB-305
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party VIVUS LLC
Original Responsible Party Gina Paderon, Vivus, Inc.
Current Study Sponsor  ICMJE VIVUS LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Medpace, Inc.
Investigators  ICMJE
Study Director: Craig Peterson VIVUS LLC
PRS Account VIVUS LLC
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP