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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

• Drug: VI-0521
  • phentermine 15 mg and topiramate CR 92 mg, po once daily
• Drug: VI-0521
  • phentermine 7.5 mg and topiramate CR 46 mg, po once daily
• Drug: topiramate
  • topiramate CR 46 mg, po once daily
• Drug: topiramate
  • topiramate CR 92 mg, po once daily
• Drug: phentermine
  • phentermine 7.5 mg, po once daily
• Drug: phentermine
  • phentermine 15 mg, po once daily
• Drug: VI-0521
  • placebo, po once daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • VI-0521; high dose phentermine/topiramate CR
• Experimental: 2
  • VI-0521; low dose phentermine/topiramate CR
• Active Comparator: 3
  • low dose topiramate CR
• Active Comparator: 4
  • high dose topiramate CR
• Active Comparator: 5
  • low dose phentermine
• Active Comparator: 6
  • high dose phentermine
• Placebo Comparator: 7

Primary Measures

• Demonstrate an improvement in percent weight loss at week 28 compared to baseline
  • Time Frame: 28 weeks
    Safety Issue?: No

Secondary Measures

• Demonstrate improvement in subjects achieving 5%-10% weight loss, change from baseline in waist circumference and change from baseline in IWQOL composite and individual domain scores at week 28.
  • Time Frame: 28 weeks
    Safety Issue?: No

Inclusion Criteria:

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

Exclusion Criteria:

• Stroke/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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: VIVUS, Inc.

Overall Clinical Trial Officials and Contacts

Craig Peterson Study Director VIVUS, Inc.  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00563368

Study ID Number: VIVUS OB-301

ClinicalTrials.gov Identifier: NCT00563368

Health Authority: United States: Food and Drug Administration