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A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00563368
Recruitment Status : Completed
First Posted : November 26, 2007
Results First Posted : September 3, 2012
Last Update Posted : March 30, 2015
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
VIVUS LLC

Study Description
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Brief Summary:
The objective of this study is to evaluate the safety and efficacy of various doses of VI-0521 compared to both placebo, and the single-agent components that comprise each combination dose. This study will provide confirmatory data to demonstrate that doses of VI-0521 have efficacy that is greater than placebo and each of the single-agent components that comprise the combination dose.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 756 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind, Parallel-Design Study Comparing Multiple Doses of VI-0521 to Placebo and Their Single-Agent Phentermine and Topiramate Constituents for the Treatment of Obesity in Adults
Study Start Date : December 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: VI-0521 Top
VI-0521; high dose phentermine/topiramate
 Drug: VI-0521
phentermine 15 mg and topiramate 92 mg, po once daily
Experimental: VI-0521 Mid
VI-0521; mid dose phentermine/topiramate
 Drug: VI-0521
phentermine 7.5 mg and topiramate 46 mg, po once daily
Active Comparator: TPM 46
mid dose topiramate
 Drug: topiramate
topiramate 46 mg, po once daily
Active Comparator: TPM 92
high dose topiramate
 Drug: topiramate
topiramate 92 mg, po once daily
Active Comparator: PHEN 7.5
mid dose phentermine
 Drug: phentermine
phentermine 7.5 mg, po once daily
Active Comparator: PHEN 15
high dose phentermine
 Drug: phentermine
phentermine 15 mg, po once daily
Placebo Comparator: Placebo Drug: VI-0521
placebo, po once daily


Outcome Measures
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Primary Outcome Measures :
  1. Percent Weight Loss From Baseline to Week 28 [ Time Frame: baseline to 28 weeks ]
    Percent weight loss from baseline to Week 28 with last observation carried forward (LOCF)

  2. Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF [ Time Frame: baseline to 28 weeks ]

Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • 70 years of age or less with body mass index (BMI) between 30 and 45 kg/m2
  • Informed Consent
  • Females of child-bearing potential must be using adequate contraception

Exclusion Criteria:

  • Stroke/myocardial infarction (MI)/unstable cardiovascular disease within 6 months
  • Clinically significant renal, hepatic or psychiatric disease
  • Unstable thyroid disease or replacement therapy
  • Nephrolithiasis
  • Obesity of known genetic or endocrine origin
  • Participation in a formal weight loss program or lifestyle intervention
  • Glaucoma or elevated intraocular pressure
  • Pregnancy or breastfeeding
  • Drug or Alcohol abuse
  • Smoking cessation within previous 3 months or plans to quit smoking during study
  • Eating disorders within past year
  • Cholelithiasis within past 6 months
  • Type 2 diabetes
  • Previous bariatric surgery
  • Bipolar disorder or psychosis
  • Steroid hormone therapy not stable for 3 months
  • Systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg
Contacts and Locations
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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): NCT00563368


Locations
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United States, North Carolina
Research Site
Durham, North Carolina, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
VIVUS LLC
Medpace, Inc.
Investigators
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Study Director: Craig Peterson VIVUS LLC
Study Chair: Kishore Gadde, MD Duke University
More Information
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Responsible Party: VIVUS LLC
ClinicalTrials.gov Identifier: NCT00563368    
Other Study ID Numbers: OB-301
First Posted: November 26, 2007    Key Record Dates
Results First Posted: September 3, 2012
Last Update Posted: March 30, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Topiramate
Phentermine
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs
 Central Nervous System Stimulants
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action