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)

• 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: VIVUS LLC
• Collaborator: Medpace, Inc.
• Information provided by (Responsible Party): VIVUS LLC

Study Description

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

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Placebo	Drug: Placebo; 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; PHEN/TPM
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; PHEN/TPM

Outcome Measures

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 ]

Eligibility Criteria

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

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).

Contacts and Locations

Sponsors and Collaborators

VIVUS LLC

Medpace, Inc.

Investigators

• Study Director: Craig Peterson; VIVUS LLC

More Information

Additional Information:

VIVUS company website 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Garvey 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.

• Responsible Party: VIVUS LLC
• ClinicalTrials.gov Identifier: NCT00796367
• Other Study ID Numbers: OB-305
• First Posted: November 24, 2008
• Results First Posted: August 31, 2012
• Last Update Posted: September 10, 2012
• Last Verified: September 2012

Keywords provided by VIVUS LLC:

Obesity

Additional relevant MeSH terms:

Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight