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 - Full Text View

Sponsors and Collaborators:	VIVUS, Inc. Medpace, Inc.
Information provided by:	VIVUS, Inc.
ClinicalTrials.gov Identifier:	NCT00796367

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 at selected study sites. This is an extension study of protocol OB-303.

Condition	Intervention	Phase
Obesity	Drug: VI-0521	Phase III

MedlinePlus related topics: Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Extension Study (From Study OB-303) to Determine the Safety and Efficacy Of VI-0521 for the Long-Term Treatment Of Obesity in Adults With Obesity-Related Co-Morbid Conditions.

Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	December 2008
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo	Drug: VI-0521 Subjects will continue to take the same treatment they were receiving when they completed study OB-303.
2: Experimental VI-0521 7.5 mg PHEN/46 mg TPM	Drug: VI-0521 Subjects will continue to take the same treatment they were receiving when they completed study OB-303.
3: Experimental VI-0521 15 mg PHEN/92 mg TPM	Drug: VI-0521 Subjects will continue to take the same treatment they were receiving when they completed study OB-303.

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 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 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 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

VIVUS company website This link exits the ClinicalTrials.gov site

Responsible Party:	Vivus, Inc. ( Gina Paderon )
Study ID Numbers:	OB-305
Study First Received:	November 20, 2008
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00796367
Health Authority:	United States: Food and Drug Administration

Keywords provided by VIVUS, Inc.:

Obesity

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on January 15, 2009