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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00554216
First Posted: November 6, 2007
Last Update Posted: September 10, 2012
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.
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
VIVUS, Inc.
November 3, 2007
November 6, 2007
July 31, 2012
September 6, 2012
September 10, 2012
November 2007
May 2009   (Final data collection date for primary outcome measure)
  • Percent Weight Loss From Baseline to Week 56 [ Time Frame: baseline to 56 weeks ]
  • Percentage of Subjects With at Least 5% Weight Loss at Week 56 [ Time Frame: baseline to 56 weeks ]
Demonstrate an improvement over placebo in mean percent loss of baseline body weight, and percent of subjects with at least a 5% weight loss. [ Time Frame: 56 weeks ]
Complete list of historical versions of study NCT00554216 on ClinicalTrials.gov Archive Site
Not Provided
  • Demonstrate improvements in obesity-associated comorbidities [ Time Frame: 56 weeks ]
  • Demonstrate an improvement over placebo in absolute weight loss and reduction in waist circumference [ Time Frame: 56 weeks ]
  • Demonstrate an improvement in quality of life [ Time Frame: 56 weeks ]
Not Provided
Not Provided
 
Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Obesity
  • Drug: VI-0521
    3.75 mg phentermine/23 mg topiramate
  • Drug: VI-0521
    15 mg phentermine/92 mg topiramate
  • Drug: Placebo matched phentermine/topiramate
    Placebo matched phentermine/topiramate
  • Experimental: VI-0521 Low
    VI-0521; low dose phentermine/topiramate (PHEN/TPM 3.75 mg/23 mg)
    Intervention: Drug: VI-0521
  • Experimental: VI-0521 Top
    Top Dose VI-0521 consisting of 15 mg of Phentermine and 92 mg of Topiramate.
    Intervention: Drug: VI-0521
  • Placebo Comparator: Placebo
    Placebo to match
    Intervention: Drug: Placebo matched phentermine/topiramate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1267
May 2009
May 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00554216
OB-302
Yes
Not Provided
Not Provided
VIVUS, Inc.
VIVUS, Inc.
Medpace, Inc.
Study Director: Craig Peterson VIVUS, Inc.
Study Chair: Kishore Gadde, MD Duke University
VIVUS, Inc.
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP