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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)

This study has been completed.
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT00796367
First received: November 20, 2008
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Obesity
Drug: VI-0521
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:
  • Percent Weight Change at End of Treatment, Week 108. [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: No ]
  • Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108. [ Time Frame: Baseline to End of Treatment ] [ Designated as safety issue: No ]

Enrollment: 676
Study Start Date: December 2008
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796367

Sponsors and Collaborators
VIVUS, Inc.
Medpace, Inc.
Investigators
Study Director: Craig Peterson VIVUS, Inc.
  More Information

Additional Information:
No publications provided by VIVUS, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT00796367     History of Changes
Other Study ID Numbers: OB-305
Study First Received: November 20, 2008
Results First Received: July 31, 2012
Last Updated: September 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by VIVUS, Inc.:
Obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Phentermine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014