Trial record 1 of 1 for:
ob-305
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:
VIVUS, Inc.
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
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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:
|
|
Experimental: VI-0521 Top
15 mg phentermine and 92 mg topiramate
|
Drug: VI-0521
15 mg phentermine and 92 mg topiramate
Other Names:
|
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 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 May 19, 2013