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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:
ClinicalTrials.gov Identifier:
NCT00553787
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.
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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

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 ]
  • Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF [ Time Frame: Baseline to 56 weeks ]

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

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:

  • 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
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): 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

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
First Submitted: November 3, 2007
First Posted: November 6, 2007
Results First Submitted: July 31, 2012
Results First Posted: September 6, 2012
Last Update Posted: September 10, 2012
Last Verified: September 2012

Keywords provided by VIVUS, Inc.:
Obesity, Type 2 diabetes

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