Sleep ApneaPhase 1/2NCT00745251

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

A Phase 1/2 study testing VI-0521 in people with Sleep Apnea, run by VIVUS LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 30 to 65 years
Conditions the study is for: Sleep Apnea
What is being tested?: VI-0521
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 45 participants
Where: 1 siteUnited States
Study dates: Aug 2008to Dec 2009
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Who cannot join

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;

Show all 17Show fewer

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);

Trial locations and contacts

1 site in 1 country.

United States1 site

Kentucky Research Group
Louisville, Kentucky, 40217

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults

Conditions: Sleep Apnea
Being tested: VI-0521, placebo
Keywords: Sleep apnea; obesity
Medical subject headings: Sleep Apnea Syndromes, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VI-0521Drug
Also called Qnexa, PHEN/TPM
15 mg Phentermine and 92 mg Topiramate
placeboDrug
placebo

Study groups in NCT00745251
Study group	Role	What they receive
VI-0521	Experimental	15 mg Phentermine and 92 mg Topiramate Receives: Drug: VI-0521
Placebo	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: between baseline and Week 28

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2008Dec 2009

First posted3 Sep 2008 (estimated)
Study startAug 2008
Primary completionSep 2009
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sleep ApneaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00745251
Sponsor's protocol ID: OB-204
Status last verified: Sep 2012
First submitted: 31 Aug 2008
Last updated: 5 Oct 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders

All Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults
ClinicalTrials.gov ID: NCT00745251
Acronym / sponsor ID: OB-204
Conditions: Sleep Apnea
Keywords: Sleep apnea; obesity
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: VIVUS LLCIndustry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: Sep 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 3 Sep 2008 (estimated)
Results: Posted 5 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
VI-0521	Experimental	Drug: VI-052115 mg Phentermine and 92 mg Topiramate
Placebo	Placebo comparator	Drug: placebo

Who may qualify

Ages: 30 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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;

Key exclusion criteria (17 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VI-0521Also: Qnexa, PHEN/TPM15 mg Phentermine and 92 mg Topiramate	Drug	VI-0521
placeboplacebo	Drug	Placebo

Primary outcome

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

1 secondary outcome

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

Results and safety

Results posted to the registry on 5 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	23	21
Top Dose	22	19

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

Time frame: between baseline and Week 28. Least squares mean (Standard Error). Unit: events/hour

Measure	Placebo n = 23	Top Dose n = 22
Value	-16.6 (4.15)	-31.46 (4.25)

Placebo vs Top Dose: Mean Difference (Final Values): -14.86, p = 0.0084, ANCOVA

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 23 (4.3%)	17 of 23 (73.9%)	Not reported
Top Dose	0 of 22 (0%)	20 of 22 (90.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Sleep Apnea

RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Charles Bowden, MD study director

VIVUS LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VI-0521 in people with Sleep Apnea, run by VIVUS LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Apnea/Hypopnea Index (AHI) Between Baseline and Week 28/Early Term. (time frame: between baseline and Week 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00745251.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2012.