Trial Outcomes & Findings for Safety and Efficacy of Vanoxerine for Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm (NCT NCT01691313)
NCT ID: NCT01691313
Last Updated: 2015-12-22
Results Overview
proportion of subjects who convert to sinus rhythm through 4 hours after start of study drug
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
104 participants
Primary outcome timeframe
baseline through 4 hours
Results posted on
2015-12-22
Participant Flow
Participant milestones
| Measure |
Vanoxerine 200mg
vanoxerine 200 mg (2x 100mg oral capsules)
Vanoxerine: single oral dose
|
Placebo
placebo to match vanoxerine oral capsule
Placebo: single oral dose
|
Vanoxerine 300mg
vanoxerine 300 mg (3x 100 mg oral capsules) single oral dose
|
Vanoxerine 400mg
vanoxerine 400 mg (4x100mg oral capsules) single oral dose
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
32
|
25
|
25
|
|
Overall Study
COMPLETED
|
22
|
32
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Vanoxerine for Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm
Baseline characteristics by cohort
| Measure |
Placebo
n=32 Participants
placebo to match vanoxerine oral capsule
Placebo: single oral dose
|
Vanoxerine 200mg
n=22 Participants
vanoxerine oral capsule, 200mg
Vanoxerine: single oral dose
|
Vanoxerine 300mg
n=25 Participants
vanoxerine oral capsule, 300mg
Vanoxerine: single oral dose
|
Vanoxerine 400mg
n=25 Participants
vanoxerine oral capsule, 400mg
Vanoxerine: single oral dose
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
61.7 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
63.4 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
68.4 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
64 years
STANDARD_DEVIATION 11 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: baseline through 4 hoursproportion of subjects who convert to sinus rhythm through 4 hours after start of study drug
Outcome measures
| Measure |
Placebo
n=32 Participants
placebo to match vanoxerine oral capsule
Placebo: single oral dose
|
Vanoxerine 200mg
n=22 Participants
vanoxerine oral capsule, 200mg
Vanoxerine: single oral dose
|
Vanoxerine 300mg
n=25 Participants
vanoxerine oral capsule, 300mg
Vanoxerine: single oral dose
|
Vanoxerine 400mg
n=25 Participants
vanoxerine oral capsule, 400mg
Vanoxerine: single oral dose
|
|---|---|---|---|---|
|
Conversion to Sinus Rhythm
|
4 participants
|
4 participants
|
11 participants
|
13 participants
|
PRIMARY outcome
Timeframe: baseline through 24 hoursproportion of subjects who convert to sinus rhythm through 24 hours after start of study drug
Outcome measures
| Measure |
Placebo
n=32 Participants
placebo to match vanoxerine oral capsule
Placebo: single oral dose
|
Vanoxerine 200mg
n=22 Participants
vanoxerine oral capsule, 200mg
Vanoxerine: single oral dose
|
Vanoxerine 300mg
n=25 Participants
vanoxerine oral capsule, 300mg
Vanoxerine: single oral dose
|
Vanoxerine 400mg
n=25 Participants
vanoxerine oral capsule, 400mg
Vanoxerine: single oral dose
|
|---|---|---|---|---|
|
Conversion to Sinus Rhythm
|
10 participants
|
13 participants
|
16 participants
|
21 participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Vanoxerine 200mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Vanoxerine 300mg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Vanoxerine 400mg
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=32 participants at risk
placebo to match vanoxerine oral capsule
Placebo: single oral dose
|
Vanoxerine 200mg
n=22 participants at risk
vanoxerine oral capsule, 200mg
Vanoxerine: single oral dose
|
Vanoxerine 300mg
n=25 participants at risk
vanoxerine oral capsule, 300mg
Vanoxerine: single oral dose
|
Vanoxerine 400mg
n=25 participants at risk
vanoxerine oral capsule, 400mg
Vanoxerine: single oral dose
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/32
|
4.5%
1/22 • Number of events 1
|
0.00%
0/25
|
0.00%
0/25
|
|
General disorders
Peripheral edema
|
0.00%
0/32
|
0.00%
0/22
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
Other adverse events
| Measure |
Placebo
n=32 participants at risk
placebo to match vanoxerine oral capsule
Placebo: single oral dose
|
Vanoxerine 200mg
n=22 participants at risk
vanoxerine oral capsule, 200mg
Vanoxerine: single oral dose
|
Vanoxerine 300mg
n=25 participants at risk
vanoxerine oral capsule, 300mg
Vanoxerine: single oral dose
|
Vanoxerine 400mg
n=25 participants at risk
vanoxerine oral capsule, 400mg
Vanoxerine: single oral dose
|
|---|---|---|---|---|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/32
|
0.00%
0/22
|
4.0%
1/25 • Number of events 1
|
8.0%
2/25 • Number of events 2
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/32
|
0.00%
0/22
|
4.0%
1/25 • Number of events 1
|
8.0%
2/25 • Number of events 2
|
|
Cardiac disorders
Ventricular extrasystoles
|
3.1%
1/32 • Number of events 1
|
0.00%
0/22
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/32
|
0.00%
0/22
|
4.0%
1/25 • Number of events 1
|
8.0%
2/25 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/32
|
4.5%
1/22 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/32
|
4.5%
1/22 • Number of events 1
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Pyrexia
|
3.1%
1/32 • Number of events 1
|
0.00%
0/22
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/32
|
4.5%
1/22 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Investigations
ECG QT prolonged
|
0.00%
0/32
|
0.00%
0/22
|
0.00%
0/25
|
12.0%
3/25 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
0.00%
0/32
|
0.00%
0/22
|
0.00%
0/25
|
12.0%
3/25 • Number of events 3
|
|
Nervous system disorders
Headache
|
0.00%
0/32
|
0.00%
0/22
|
0.00%
0/25
|
8.0%
2/25 • Number of events 2
|
|
Vascular disorders
Hypotension
|
3.1%
1/32 • Number of events 1
|
0.00%
0/22
|
4.0%
1/25 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/32
|
0.00%
0/22
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
General disorders
Asthenia
|
0.00%
0/32
|
4.5%
1/22 • Number of events 1
|
0.00%
0/25
|
0.00%
0/25
|
|
General disorders
Chest discomfort
|
0.00%
0/32
|
0.00%
0/22
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Oedema Peripheral
|
0.00%
0/32
|
0.00%
0/22
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/32
|
0.00%
0/22
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/32
|
4.5%
1/22 • Number of events 1
|
0.00%
0/25
|
0.00%
0/25
|
|
Investigations
International normalized ratio increased
|
0.00%
0/32
|
4.5%
1/22 • Number of events 1
|
0.00%
0/25
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/32
|
0.00%
0/22
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/32
|
0.00%
0/22
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Nervous system disorders
Syncope
|
0.00%
0/32
|
0.00%
0/22
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/32
|
0.00%
0/22
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/32
|
0.00%
0/22
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/32
|
0.00%
0/22
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER