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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Obesity
Type 2 Diabetes
 Drug: VI-0521
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Adults With Obesity-Related Co-Morbid Conditions

Resource links provided by NLM:

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 a Weight Loss of at Least 5% at Week 56 With LOCF [ Time Frame: Baseline to 56 weeks ] [ Designated as safety issue: No ]

Enrollment: 2487
Study Start Date: November 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VI-0521 Top
high dose experimental treatment
 Drug: VI-0521
phentermine 15 mg and topiramate 92 mg, po once daily
Experimental: VI-0521 Mid
mid dose experimental treatment
 Drug: VI-0521
phentermine 7.5 mg and topiramate 46 mg, po once daily
Placebo Comparator: Placebo
Placebo
 Drug: VI-0521
placebo

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00553787

Locations
United States, Alabama
Research Site
Birmingham, Alabama, United States, 35294
United States, Connecticut
Research Site
Ridgefield, Connecticut, United States, 06877
United States, New York
Research Site
New York, New York, United States, 10025
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 by VIVUS, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT00553787     History of Changes
Other Study ID Numbers: OB-303
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, Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013