CompletedNCT00745251Updated Oct 5, 2012Results posted

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

A Phase 1/2 interventional study of VI-0521 and placebo in Sleep Apnea, sponsored by VIVUS LLC. Completed at 1 site in United States. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-10-05.

Sponsored by VIVUS LLC · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 45
Allocation: Randomized
Ages: 30 Years to 65 Years
Sex: All

Study 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.

Conditions studied

Sleep Apnea

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Keywords

Sleep apnea; obesity

In context

Sleep Apnea Syndromes

2,183 studies on the registry are indexed under Sleep Apnea Syndromes; 284 are open to participants now.

This study's enrollment of 45 is below the median of 53 across 1,400 interventional studies indexed under Sleep Apnea Syndromes.

Browse Sleep Apnea Syndromes studies →

Lead sponsor

VIVUS LLC is the lead sponsor of 43 studies on the registry; 2 are open to participants now.

Browse VIVUS LLC studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 30 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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);

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 45 participants (actual)

Study arms

Experimental
VI-0521
15 mg Phentermine and 92 mg Topiramate
Drug: VI-0521
Placebo comparator
Placebo
Drug: placebo

Interventions

DrugVI-0521
Drug pages: Phentermine · Topiramate
15 mg Phentermine and 92 mg Topiramate
Also known as: Qnexa, PHEN/TPM
Drugplacebo
placebo

What researchers measure

Primary outcomes

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
Time frame: between baseline and Week 28

Secondary outcomes

Percent Change in Weight From Baseline to Week 28
Time frame: baseline to week 28

Results

Posted Oct 5, 2012

Participant flow

Subject recruitment occurred in 1 investigative site in the U.S. between August 2008 to February 2009

Participant flow — Overall Study
Milestone	Placebo	Top Dose
Started	23	22
Completed	21	19
Not completed	2	3
Withdrew: Adverse event	1	2
Withdrew: Withdrawal by subject	1	1

Outcome measures

PrimaryChange 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

Time frame:: between baseline and Week 28
Reported as:: Least squares mean · events/hour

Change in the Apnea/Hypopnea Index (AHI) Between Baseline and Week 28/Early Term.
events/hour	Placebo	Top Dose
Change in the Apnea/Hypopnea Index (AHI) Between Baseline and Week 28/Early Term.	-16.6 ± 4.15	-31.46 ± 4.25

Statistical analysis

Placebo vs Top Dose · ANCOVA · p = 0.0084 · Mean difference (final values): -14.86

SecondaryPercent Change in Weight From Baseline to Week 28

Time frame:: baseline to week 28
Reported as:: Least squares mean · percent change

Percent Change in Weight From Baseline to Week 28
percent change	Placebo	Top Dose
Percent Change in Weight From Baseline to Week 28	-10.26 ± 1.17	-4.21 ± 1.15

Statistical analysis

Placebo vs Top Dose · ANCOVA · p = 0.0006 · Mean difference (final values): -6.05 · 95% CI -9.37 to -2.74

Adverse events

Collected over AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.. Non-serious events are listed at a 4% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	—	1/23 (4.3%)	17/23 (73.9%)
Top Dose	—	0/22 (0%)	20/22 (90.9%)

Most frequent serious events

Most frequent serious events
Event	Placebo	Top Dose
cerebrovascular accidentNervous system disorders	1/23	0/22

Most frequent other events

Showing 10 of 54

Most frequent other events
Event	Placebo	Top Dose
dry mouthGastrointestinal disorders	0/23	11/22
dysgeusiaNervous system disorders	0/23	6/22
sinusitisInfections and infestations	0/23	5/22
upper respiratory tract infectionInfections and infestations	1/23	4/22
gastroenteritis viralInfections and infestations	4/23	2/22
constipationGastrointestinal disorders	2/23	3/22
diarrheaGastrointestinal disorders	2/23	3/22
hypoaesthesiaNervous system disorders	0/23	3/22
parethesiaNervous system disorders	0/23	3/22
nasopharyngitisInfections and infestations	1/23	3/22

Baseline characteristics

Age Continuous
Age Continuous(years)	Placebo	Top Dose	Total
Mean	51.4 ± 5.74	53.4 ± 6.95	52.4 ± 6.37

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	Top Dose	Total
Female	8	13	21
Male	15	9	24

Region of Enrollment
Region of Enrollment(participants)	Placebo	Top Dose	Total
United States	23	22	45

Study locations

1 site

Kentucky Research Group
Louisville, Kentucky 40217, United States

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2008, a primary completion of Sep 2009 and a completion of Dec 2009. It does not say whether these dates are actual or estimated.

Results were first posted in Oct 2012, 3 years 1 month after primary completion. A results delay was requested in May 2011.

How these figures are worked out, and which studies are left out of them.

Registered: Aug 31, 2008
First posted: Sep 3, 2008
Start: Aug 2008
Primary completionActual: Sep 2009
CompletionActual: Dec 2009
Results delay requested: May 13, 2011
Results first posted: Oct 5, 2012
Last update: Oct 5, 2012

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Oct 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00745251
Lead sponsor: VIVUS LLC
Responsible party: Sponsor
First posted: Sep 3, 2008
Start date: Aug 2008
Primary completion: Sep 2009
Completion: Dec 2009
Results posted: Oct 5, 2012
Last update: Oct 5, 2012

Study contacts

Charles Bowden, MD

study director · VIVUS LLC

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Phentermine · Topiramate

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