A Study of VI-0521 for the Treatment of Obstructive Sleep... | NCT00745251

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

NCT00745251

Sponsor

VIVUS LLC

Status

Completed

Last Update Posted

Oct 5, 2012Estimated

Enrollment

45Actual

Phase

Phase 1Phase 2

Conditions

Sleep Apnea

Interventions

VI-0521
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

Participant Flow Module

Pre-assignment Details

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Sep 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Aug 31, 2008

First Submission Date that Met QC Criteria

Aug 31, 2008

First Posted Date

Sep 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Jul 31, 2012

Results First Submitted that Met QC Criteria

Sep 5, 2012

Results First Posted Date

Oct 5, 2012Estimated

Certification/Extension (aka Delayed Results) First Submitted Date

May 13, 2011

Certification/Extension First Submitted that Passed QC Review

May 13, 2011

Certification/Extension First Posted Date

May 18, 2011Estimated

Last Update Submitted Date

Sep 5, 2012

Last Update Posted Date

Oct 5, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Label	Type	Description	Intervention Names
VI-0521	Experimental	15 mg Phentermine and 92 mg Topiramate	Drug: VI-0521
Placebo	Placebo Comparator		Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
VI-0521	Drug	15 mg Phentermine and 92 mg Topiramate	VI-0521	Qnexa

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in the Apnea/Hypopnea Index (AHI) Between Baseline and Week 28/Early Term.	AHI is calculated as the mean number of apnea or hypopnea episodes (each lasting a minimum of 10 second) observed per hour of sleep	between baseline and Week 28

Secondary Outcomes

Measure	Description	Time Frame
Percent Change in Weight From Baseline to Week 28		baseline to week 28

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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);

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Charles Bowden, MD	VIVUS LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Kentucky Research Group		Louisville	Kentucky	40217	United States

ID	Title	Description
FG000	Placebo
FG001	Top Dose	PHEN/TPM 15mg/92mg

Baseline Characteristics Module

Baseline Analysis Population Description

Not provided

Type of Units Analyzed

Not provided

Arm/Group Information

ID	Title	Description
BG000	Placebo
BG001	Top Dose	PHEN/TPM 15mg/92mg
BG002	Total

Denominators

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in the Apnea/Hypopnea Index (AHI) Between Baseline and Week 28/Early Term.

AHI is calculated as the mean number of apnea or hypopnea episodes (each lasting a minimum of 10 second) observed per hour of sleep

Intent-to-treat Last-observation-carried-forward (ITT-LOCF)

Posted

Least Squares Mean

Standard Error

events/hour

between baseline and Week 28

ID	Title	Description
OG000	Placebo
OG001	Top Dose	PHEN/TPM 15mg/92mg

Units

Adverse Events Module

Frequency Threshold

Time Frame

AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.

Description

Not provided

All-Cause Mortality Comment

Not provided

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
cerebrovascular accident	Nervous system disorders	MedDRA (10.1)	Systematic Assessment

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
tinnitus	Ear and labyrinth disorders	MedDRA (10.1)	Systematic Assessment

Title	Organization	Phone	Extension	Email
Wesley W. Day, PhD	Vivus, Inc	650-934-5200		day@vivus.com

ID	Term
D012891	Sleep Apnea Syndromes
D009765	Obesity

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

ID	Term
C577572	Qnexa

Other Details

After Sponsor's written notification that publication of results is no longer planned or 12 months after termination of the study at all sites, Institution & PI may publish, upon written approval from Sponsor, results of the Study. Sponsor will be given the opportunity to review any proposed publication at least 60 days prior to submission for publication or disclosure. Upon Sponsor's written request, Institution and PI shall not publish or disclose information related to the Study.