Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions

This study has been completed.
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT00553787
First received: November 3, 2007
Last updated: September 5, 2012
Last verified: September 2012

November 3, 2007
September 5, 2012
November 2007
June 2009   (final data collection date for primary outcome measure)
  • Percent Weight Loss From Baseline to Week 56 [ Time Frame: Baseline to 56 weeks ] [ Designated as safety issue: No ]
  • Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF [ Time Frame: Baseline to 56 weeks ] [ Designated as safety issue: No ]
Demonstrate an improvement over placebo in mean percent loss of baseline body weight and percent of subjects with at least 5% weight loss [ Time Frame: 56 weeks ]
Complete list of historical versions of study NCT00553787 on ClinicalTrials.gov Archive Site
Not Provided
  • Demonstrate improvements in HgbA1c and other 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 Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions
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 Adults With Obesity-Related Co-Morbid Conditions

The purpose of this study is to evaluate the efficacy and safety of VI0521 compared to placebo in treatment of obesity in an adult population with obesity related co-morbid conditions.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Obesity
  • Type 2 Diabetes
  • Drug: VI-0521
    phentermine 15 mg and topiramate 92 mg, po once daily
  • Drug: VI-0521
    phentermine 7.5 mg and topiramate 46 mg, po once daily
  • Drug: VI-0521
    placebo
  • Experimental: VI-0521 Top
    high dose experimental treatment
    Intervention: Drug: VI-0521
  • Experimental: VI-0521 Mid
    mid dose experimental treatment
    Intervention: Drug: VI-0521
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: VI-0521
Gadde KM, Allison DB, Ryan DH, Peterson CA, Troupin B, Schwiers ML, Day WW. Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial. Lancet. 2011 Apr 16;377(9774):1341-52. doi: 10.1016/S0140-6736(11)60205-5. Epub 2011 Apr 8. Erratum in: Lancet. 2011 Apr 30;377(9776):1494.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2487
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Informed Consent
  • BMI ≥ 27 (no lower BMI limit for Type 2 diabetics)
  • 70 years of age or less
  • Have 2 or more of the following obesity-related co-morbid conditions:

    • Systolic blood pressure 140-160 mmHg (130-160 if diabetic);
    • Diastolic blood pressure 90-100 mmHg (85-100 if diabetic);
    • Requirement for 2 or more medications to achieve control (<140/90 mmHg)
  • Triglyceride level between 200-400 mg/dL or requirement for 2 or more medications to achieve control (<200 mg/dL)
  • At lease one of the following metabolic criteria:

    • Fasting blood glucose level > 100 mg/dL
    • Glucose level > 140 mg/dL
    • Diagnosis of type 2 diabetes
  • Waist circumference ≥ 102 cm for men or ≥88 cm for women

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 intraocular pressure
  • Pregnancy or breastfeeding
  • Drug or 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 1 diabetes or use of any antidiabetic medication other than metformin
  • Previous bariatric surgery
  • Bipolar disorder or psychosis
  • Steroid hormone therapy
  • Systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg
  • Creatinine clearance < 60 mL/minute
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00553787
OB-303
Yes
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