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Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults

This study has been completed.
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT00554216
First received: November 3, 2007
Last updated: September 5, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521 compared to placebo in treatment of obesity in an adult population with BMI ≥ 35.


Condition Intervention Phase
Obesity
 Drug: VI-0521
Drug: Placebo matched phentermine/topiramate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Determine the Safety and Efficacy of VI-0521 in the Treatment of Obesity in an Adult Population With BMI ≥ 35

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:
  • Percent Weight Loss From Baseline to Week 56 [ Time Frame: baseline to 56 weeks ] [ Designated as safety issue: No ]
  • Percentage of Subjects With at Least 5% Weight Loss at Week 56 [ Time Frame: baseline to 56 weeks ] [ Designated as safety issue: No ]

Enrollment: 1267
Study Start Date: November 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VI-0521 Low
VI-0521; low dose phentermine/topiramate (PHEN/TPM 3.75 mg/23 mg)
 Drug: VI-0521
3.75 mg phentermine/23 mg topiramate
Experimental: VI-0521 Top
Top Dose VI-0521 consisting of 15 mg of Phentermine and 92 mg of Topiramate.
 Drug: VI-0521
15 mg phentermine/92 mg topiramate
Placebo Comparator: Placebo
Placebo to match
 Drug: Placebo matched phentermine/topiramate
Placebo matched phentermine/topiramate

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body mass index (BMI) ≥ 35 kg/m2
  • Informed consent
  • 70 years of age or less
  • Triglyceride level ≤ 200 mg/dL with treatment of 0 or 1 medications
  • Blood pressure of ≤ 140/90 mmHg with treatment of 0-2 medications for hypertension
  • Fasting blood glucose level of ≤ 110 mg/dL

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
  • History of glaucoma or intraocular pressure
  • Pregnancy or breastfeeding
  • Alcohol abuse
  • Smoking cessation within previous 3 months or plans to quit smoking during study
  • Eating disorders
  • Cholelithiasis within past 6 months
  • Excluded medications
  • Type 2 diabetes
  • Previous bariatric surgery
  • History of bipolar disorder or psychosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554216

Locations
United States, California
Research Site
San Diego, California, United States, 92130
United States, Connecticut
Research
Ridgefield, Connecticut, United States, 06877
United States, North Carolina
Research Site
Durham, North Carolina, United States, 27710
United States, Ohio
Research Site
Toledo, Ohio, United States, 43623
United States, Texas
Research Site
Austin, Texas, United States, 78731
Sponsors and Collaborators
VIVUS, Inc.
Medpace, Inc.
Investigators
Study Director: Craig Peterson VIVUS, Inc.
Study Chair: Kishore Gadde, MD Duke University
  More Information

No publications provided

Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT00554216     History of Changes
Other Study ID Numbers: OB-302
Study First Received: November 3, 2007
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, morbid obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Phentermine
Topiramate
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
Anticonvulsants
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 23, 2013