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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
Medpace, Inc.
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Obesity Drug: VI-0521 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 676 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : July 2010

Arm Intervention/treatment
Placebo Comparator: Placebo
Drug: Placebo

Experimental: VI-0521 Mid
7.5 mg phentermine and 46 mg topiramate
Drug: VI-0521
7.5 mg phentermine and 46 mg topiramate
Other Names:
  • Qsymia
  • Qnexa

Experimental: VI-0521 Top
15 mg phentermine and 92 mg topiramate
Drug: VI-0521
15 mg phentermine and 92 mg topiramate
Other Names:
  • Qsymia
  • Qnexa

Primary Outcome Measures :
  1. Percent Weight Change at End of Treatment, Week 108. [ Time Frame: From baseline to end of treatment ]
  2. Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108. [ Time Frame: Baseline to End of Treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00796367

Sponsors and Collaborators
Medpace, Inc.
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Study Director: Craig Peterson VIVUS LLC
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: VIVUS LLC
ClinicalTrials.gov Identifier: NCT00796367    
Other Study ID Numbers: OB-305
First Posted: November 24, 2008    Key Record Dates
Results First Posted: August 31, 2012
Last Update Posted: September 10, 2012
Last Verified: September 2012
Keywords provided by VIVUS LLC:
Additional relevant MeSH terms:
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Nutrition Disorders
Body Weight