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Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults

NCT ID: NCT00554216

Last Updated: 2012-09-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-05-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521 compared to placebo in treatment of obesity in an adult population with BMI ≥ 35.

Detailed Description

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Conditions

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Obesity

Keywords

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Obesity, morbid obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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VI-0521 Low

VI-0521; low dose phentermine/topiramate (PHEN/TPM 3.75 mg/23 mg)

Group Type EXPERIMENTAL

VI-0521

Intervention Type DRUG

3.75 mg phentermine/23 mg topiramate

VI-0521 Top

Top Dose VI-0521 consisting of 15 mg of Phentermine and 92 mg of Topiramate.

Group Type EXPERIMENTAL

VI-0521

Intervention Type DRUG

15 mg phentermine/92 mg topiramate

Placebo

Placebo to match

Group Type PLACEBO_COMPARATOR

Placebo matched phentermine/topiramate

Intervention Type DRUG

Placebo matched phentermine/topiramate

Interventions

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VI-0521

3.75 mg phentermine/23 mg topiramate

Intervention Type DRUG

VI-0521

15 mg phentermine/92 mg topiramate

Intervention Type DRUG

Placebo matched phentermine/topiramate

Placebo matched phentermine/topiramate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body mass index (BMI) ≥ 35 kg/m2
* Informed consent
* 70 years of age or less
* Triglyceride level ≤ 200 mg/dL with treatment of 0 or 1 medications
* Blood pressure of ≤ 140/90 mmHg with treatment of 0-2 medications for hypertension
* Fasting blood glucose level of ≤ 110 mg/dL

Exclusion Criteria

* Stroke/myocardial infarction (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
* History of glaucoma or intraocular pressure
* Pregnancy or breastfeeding
* 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 2 diabetes
* Previous bariatric surgery
* History of bipolar disorder or psychosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medpace, Inc.

INDUSTRY

Sponsor Role collaborator

VIVUS LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Craig Peterson

Role: STUDY_DIRECTOR

VIVUS LLC

Kishore Gadde, MD

Role: STUDY_CHAIR

Duke University

Locations

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Research Site

San Diego, California, United States

Site Status

Research

Ridgefield, Connecticut, United States

Site Status

Research Site

Durham, North Carolina, United States

Site Status

Research Site

Toledo, Ohio, United States

Site Status

Research Site

Austin, Texas, United States

Site Status

Countries

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United States

References

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Guo F, Garvey WT. Cardiometabolic Disease Staging Predicts Effectiveness of Weight-Loss Therapy to Prevent Type 2 Diabetes: Pooled Results From Phase III Clinical Trials Assessing Phentermine/Topiramate Extended Release. Diabetes Care. 2017 Jul;40(7):856-862. doi: 10.2337/dc17-0088. Epub 2017 Apr 28.

Reference Type DERIVED
PMID: 28455281 (View on PubMed)

Other Identifiers

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OB-302

Identifier Type: -

Identifier Source: org_study_id