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A Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults

NCT ID: NCT00745251

Last Updated: 2012-10-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-12-31

Brief Summary

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The primary objectives of this study are to evaluate the safety and efficacy of VI-0521 compared to placebo in the treatment of obese adults with obstructive sleep apnea (OSA) and to assess the relative contributions of weight loss on parameters of OSA in these subjects.

Detailed Description

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Conditions

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Sleep Apnea

Keywords

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Sleep apnea; obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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VI-0521

15 mg Phentermine and 92 mg Topiramate

Group Type EXPERIMENTAL

VI-0521

Intervention Type DRUG

15 mg Phentermine and 92 mg Topiramate

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

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VI-0521

15 mg Phentermine and 92 mg Topiramate

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Other Intervention Names

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Qnexa PHEN/TPM

Eligibility Criteria

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Inclusion Criteria

* Obese adults 30 - 65 years old (inclusive);
* Women of child-bearing potential must be using adequate contraception;
* BMI between 30 and 40 kg/m2 (inclusive);
* Diagnosis of OSA syndrome with Apnea/Hypopnea Index (AHI) of 15 or greater;
* Unwilling or unable to comply with CPAP treatment;

Exclusion Criteria

* Known allergy or hypersensitivity to phentermine or topiramate;
* Sleep disorder other than OSA syndrome;
* Women who are pregnant, breast feeding, or intend to become pregnant during the study;
* Presence of unstable angina or heart failure corresponding to NYHA functional class III or IV;
* History of myocardial infarction or coronary revascularization within the past year; any history of stroke;
* Presence of any clinically significant abnormality on electrocardiogram;
* Use of any prescription CNS stimulants;
* History of cholecystitis or cholelithiasis unless treated by cholecystectomy;
* History of glaucoma or any past or present use of medications to treat increased intraocular pressure;
* Weight gain or loss of greater than 5 kg, use of a very low-calorie diet, or participation in a formal weight loss program (investigational or otherwise) within the past 3 months;
* Previous bariatric surgery;
* Shift workers or any subjects with a circadian rhythm disorder;
* Professional drivers or commercial pilots;
* History of nephrolithiasis;
* More than one lifetime episode of major depression;
* History of bipolar disorder, obsessive compulsive disorder, borderline personality disorder, psychotic depression, schizophrenia, schizoaffective disorder, or any other psychotic disorder; history of any psychiatric hospitalization;
* History of a seizure disorder; concurrent use of any anticonvulsant drug (other than assigned study drug);
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VIVUS LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Bowden, MD

Role: STUDY_DIRECTOR

VIVUS LLC

Locations

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Kentucky Research Group

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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OB-204

Identifier Type: -

Identifier Source: org_study_id