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

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ClinicalTrials.gov Identifier: NCT00554216
Recruitment Status : Completed
First Posted : November 6, 2007
Results First Posted : September 6, 2012
Last Update Posted : September 10, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Drug: VI-0521 Drug: Placebo matched phentermine/topiramate Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : November 2007
Primary Completion Date : May 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Percent Weight Loss From Baseline to Week 56 [ Time Frame: baseline to 56 weeks ]
  2. Percentage of Subjects With at Least 5% Weight Loss at Week 56 [ Time Frame: baseline to 56 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT00554216     History of Changes
Other Study ID Numbers: OB-302
First Posted: November 6, 2007    Key Record Dates
Results First Posted: September 6, 2012
Last Update Posted: September 10, 2012
Last Verified: September 2012

Keywords provided by VIVUS, Inc.:
Obesity, morbid obesity

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