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

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 III

MedlinePlus related topics:

Diabetes Obesity Weight Control

ChemIDplus related topics:

Topiramate Phentermine Phentermine hydrochloride

U.S. FDA Resources

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

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:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Demonstrate improvements in HgbA1c and other obesity-associated comorbidities [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
Demonstrate an improvement over placebo in absolute weight loss and reduction in waist circumference [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
Demonstrate an improvement in quality of life [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	2500
Study Start Date:	November 2007
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental high dose experimental treatment	Drug: VI-0521 phentermine 15 mg and topiramate 92 mg, po once daily
2: Experimental low dose experimental treatment	Drug: VI-0521 phentermine 7.5 mg and topiramate 46 mg, po once daily
3: Placebo Comparator 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

Responsible Party:	VIVUS ( Craig Peterson, Sr. Director Clinical Research )
Study ID Numbers:	VIVUS OB-303
First Received:	November 3, 2007
Last Updated:	May 2, 2008
ClinicalTrials.gov Identifier:	NCT00553787
Health Authority:	United States: Food and Drug Administration

Keywords provided by VIVUS, Inc.:

Obesity, Type 2 diabetes

Study placed in the following topic categories:

Obesity

Metabolic Diseases

Diabetes Mellitus

Endocrine System Diseases

Overweight

Phentermine

Body Weight

Signs and Symptoms

Diabetes Mellitus, Type 2

Topiramate

Nutrition Disorders

Overnutrition

Endocrinopathy

Glucose Metabolism Disorders

Metabolic disorder

ClinicalTrials.gov processed this record on October 07, 2008

Sponsors and Collaborators:	VIVUS, Inc. Medpace, Inc.
Information provided by:	VIVUS, Inc.
ClinicalTrials.gov Identifier:	NCT00553787