NCT00745251

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

October 5, 2012

Completed
Last Updated

October 5, 2012

Status Verified

September 1, 2012

Enrollment Period

1.1 years

First QC Date

August 31, 2008

Results QC Date

July 31, 2012

Last Update Submit

September 5, 2012

Conditions

Sleep Apnea

Keywords

Sleep apnea; obesity

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Percent Change in Weight From Baseline to Week 28

    baseline to week 28

Study Arms (2)

VI-0521

EXPERIMENTAL

15 mg Phentermine and 92 mg Topiramate

Drug: VI-0521

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

VI-0521DRUG

15 mg Phentermine and 92 mg Topiramate

Also known as: Qnexa, PHEN/TPM
VI-0521
placeboDRUG

placebo

Placebo

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kentucky Research Group

Louisville, Kentucky, 40217, United States

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesObesity

Interventions

Qnexa

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

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

Study Officials

  • Charles Bowden, MD

    VIVUS LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2008

First Posted

September 3, 2008

Study Start

August 1, 2008

Primary Completion

September 1, 2009

Study Completion

December 1, 2009

Last Updated

October 5, 2012

Results First Posted

October 5, 2012

Record last verified: 2012-09

Locations

US(1)