Trial Outcomes & Findings for A Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults (NCT NCT00745251)
NCT ID: NCT00745251
Last Updated: 2012-10-05
Results Overview
AHI is calculated as the mean number of apnea or hypopnea episodes (each lasting a minimum of 10 second) observed per hour of sleep
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
45 participants
Primary outcome timeframe
between baseline and Week 28
Results posted on
2012-10-05
Participant Flow
Subject recruitment occurred in 1 investigative site in the U.S. between August 2008 to February 2009
Participant milestones
| Measure |
Placebo
|
Top Dose
PHEN/TPM 15mg/92mg
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
22
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Placebo
|
Top Dose
PHEN/TPM 15mg/92mg
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
A Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults
Baseline characteristics by cohort
| Measure |
Placebo
n=23 Participants
|
Top Dose
n=22 Participants
PHEN/TPM 15mg/92mg
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
51.4 years
STANDARD_DEVIATION 5.74 • n=5 Participants
|
53.4 years
STANDARD_DEVIATION 6.95 • n=7 Participants
|
52.4 years
STANDARD_DEVIATION 6.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
22 participants
n=7 Participants
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: between baseline and Week 28Population: Intent-to-treat Last-observation-carried-forward (ITT-LOCF)
AHI is calculated as the mean number of apnea or hypopnea episodes (each lasting a minimum of 10 second) observed per hour of sleep
Outcome measures
| Measure |
Placebo
n=23 Participants
|
Top Dose
n=22 Participants
PHEN/TPM 15mg/92mg
|
|---|---|---|
|
Change in the Apnea/Hypopnea Index (AHI) Between Baseline and Week 28/Early Term.
|
-16.6 events/hour
Standard Error 4.15
|
-31.46 events/hour
Standard Error 4.25
|
SECONDARY outcome
Timeframe: baseline to week 28Population: Intent-to-treat Last-observation-carried-forward (ITT-LOCF)
Outcome measures
| Measure |
Placebo
n=23 Participants
|
Top Dose
n=22 Participants
PHEN/TPM 15mg/92mg
|
|---|---|---|
|
Percent Change in Weight From Baseline to Week 28
|
-10.26 percent change
Standard Error 1.17
|
-4.21 percent change
Standard Error 1.15
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Top Dose
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=23 participants at risk
|
Top Dose
n=22 participants at risk
PHEN/TPM 15mg/92mg
|
|---|---|---|
|
Nervous system disorders
cerebrovascular accident
|
4.3%
1/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
Other adverse events
| Measure |
Placebo
n=23 participants at risk
|
Top Dose
n=22 participants at risk
PHEN/TPM 15mg/92mg
|
|---|---|---|
|
Renal and urinary disorders
nocturia
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Renal and urinary disorders
urinary hesitation
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Reproductive system and breast disorders
perineal cyst
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
allergic cough
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
dry throat
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
9.1%
2/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
paranasal sinus hypersecretion
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
sinus congestion
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Vascular disorders
flushing
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Ear and labyrinth disorders
tinnitus
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
9.1%
2/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Gastrointestinal disorders
constipation
|
8.7%
2/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
13.6%
3/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Gastrointestinal disorders
diarrhea
|
8.7%
2/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
13.6%
3/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Gastrointestinal disorders
dry mouth
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
50.0%
11/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Gastrointestinal disorders
nausea
|
4.3%
1/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
9.1%
2/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Nervous system disorders
disturbance in attention
|
4.3%
1/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
9.1%
2/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Nervous system disorders
dysgeusia
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
27.3%
6/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Nervous system disorders
headache
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
9.1%
2/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Nervous system disorders
hypoaesthesia
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
13.6%
3/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Nervous system disorders
parethesia
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
13.6%
3/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Nervous system disorders
somnolence
|
8.7%
2/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
General disorders
feeling jittery
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
9.1%
2/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Eye disorders
keratitis
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Eye disorders
vision blurred
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Gastrointestinal disorders
gingival bleeding
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Gastrointestinal disorders
gingival pain
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Gastrointestinal disorders
hematochezia
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Gastrointestinal disorders
hemorrhoids
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
General disorders
chest discomfort
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
General disorders
irritability
|
4.3%
1/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
General disorders
mucosal dryness
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Infections and infestations
gastroenteritis viral
|
17.4%
4/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
9.1%
2/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Infections and infestations
nasopharyngitis
|
4.3%
1/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
13.6%
3/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Infections and infestations
sinusitis
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
22.7%
5/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Infections and infestations
tonsillitis
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Infections and infestations
upper respiratory tract infection
|
4.3%
1/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
18.2%
4/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Infections and infestations
viral upper respiratory tract infection
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Injury, poisoning and procedural complications
hand fracture
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Injury, poisoning and procedural complications
procedural pain
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Metabolism and nutrition disorders
food craving
|
4.3%
1/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
4.3%
1/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
exostosis
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
flank pain
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Nervous system disorders
amnesia
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Nervous system disorders
dizziness
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Nervous system disorders
parosmia
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Nervous system disorders
tremor
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Psychiatric disorders
agitation
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Psychiatric disorders
mood altered
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Psychiatric disorders
sleep disorder
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Psychiatric disorders
stress
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Renal and urinary disorders
dysuria
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Renal and urinary disorders
nephrolithiasis
|
0.00%
0/23 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.5%
1/22 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER