Sleep Apnea
Conditions
Keywords
Sleep apnea; obesity
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.
Interventions
DRUGVI-0521
15 mg Phentermine and 92 mg Topiramate
DRUGplacebo
placebo
Sponsors
VIVUS LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Apnea/Hypopnea Index (AHI) Between Baseline and Week 28/Early Term. | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change in Weight From Baseline to Week 28 | baseline to week 28 |
Countries
United States
Participant flow
Recruitment details
Subject recruitment occurred in 1 investigative site in the U.S. between August 2008 to February 2009
Participants by arm
| Arm | Count |
|---|---|
| Placebo | 23 |
| Top Dose PHEN/TPM 15mg/92mg | 22 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | Top Dose | Total |
|---|---|---|---|
| Age Continuous | 51.4 years STANDARD_DEVIATION 5.74 | 53.4 years STANDARD_DEVIATION 6.95 | 52.4 years STANDARD_DEVIATION 6.37 |
| Region of Enrollment United States | 23 participants | 22 participants | 45 participants |
| Sex: Female, Male Female | 8 Participants | 13 Participants | 21 Participants |
| Sex: Female, Male Male | 15 Participants | 9 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 23 | 20 / 22 |
| serious Total, serious adverse events | 1 / 23 | 0 / 22 |
Outcome results
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
Time frame: between baseline and Week 28
Population: Intent-to-treat Last-observation-carried-forward (ITT-LOCF)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in the Apnea/Hypopnea Index (AHI) Between Baseline and Week 28/Early Term. | -16.6 events/hour | Standard Error 4.15 |
| Top Dose | Change in the Apnea/Hypopnea Index (AHI) Between Baseline and Week 28/Early Term. | -31.46 events/hour | Standard Error 4.25 |
p-value: 0.0084ANCOVA
Secondary
Percent Change in Weight From Baseline to Week 28
Time frame: baseline to week 28
Population: Intent-to-treat Last-observation-carried-forward (ITT-LOCF)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Weight From Baseline to Week 28 | -10.26 percent change | Standard Error 1.17 |
| Top Dose | Percent Change in Weight From Baseline to Week 28 | -4.21 percent change | Standard Error 1.15 |
p-value: 0.000695% CI: [-9.37, -2.74]ANCOVA