Trial Outcomes & Findings for Safety and Efficacy of Vanoxerine for the Conversion of Subjects With Recent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm (NCT NCT02454283)

Last Updated: 2016-10-17

Results Overview

Conversion to sinus rhythm (or atrial paced rhythm in the case of subjects with a pacemaker and atrial leads) documented by ECG (Holter ECG, 12-lead ECG, monitor lead ECG, or other format ECG) of at least 1 continuous minute within the 24 hours defined by the time of study drug administration through 24 hours after the time of study drug administration.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

41 participants

Primary outcome timeframe

24 hours

Results posted on

2016-10-17

Participant Flow

Participant milestones

Participant milestones
Measure	Vanoxerine HCl Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose Vanoxerine HCl	Placebo identically matching placebo capsules, orally, single-dose Placebo
Overall Study STARTED	26	15
Overall Study COMPLETED	26	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Vanoxerine for the Conversion of Subjects With Recent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vanoxerine HCl n=26 Participants Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose Vanoxerine HCl	Placebo n=15 Participants identically matching placebo capsules, orally, single-dose Placebo	Total n=41 Participants Total of all reporting groups
Age, Continuous	68.1 years STANDARD_DEVIATION 9.3 • n=5 Participants	66.9 years STANDARD_DEVIATION 11.3 • n=7 Participants	67.7 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	8 Participants n=7 Participants	29 Participants n=5 Participants
Prior AF/AFL	16 participants n=5 Participants	7 participants n=7 Participants	23 participants n=5 Participants
Hypertension	16 participants n=5 Participants	11 participants n=7 Participants	27 participants n=5 Participants
Diabetes mellitus	4 participants n=5 Participants	0 participants n=7 Participants	4 participants n=5 Participants
Hyperlipidemia	8 participants n=5 Participants	6 participants n=7 Participants	14 participants n=5 Participants
COPD	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Hyperthyroidism	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Hypothyroidism	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants
Prior stroke	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Pacemaker	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Heart failure	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants
LVEF, mean	54.3 % STANDARD_DEVIATION 8.4 • n=5 Participants	55.1 % STANDARD_DEVIATION 12.4 • n=7 Participants	54.6 % STANDARD_DEVIATION 9.7 • n=5 Participants
Mitral stenosis	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Mitral regurgitation	10 participants n=5 Participants	4 participants n=7 Participants	14 participants n=5 Participants
Aortic stenosis	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Aortic regurgitation	4 participants n=5 Participants	1 participants n=7 Participants	5 participants n=5 Participants
Ischemic heart disease	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Prior revascularization (PCI or CABG)	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Prior antiarrhythmic drug therapy	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Prior catheter ablation of AF	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Aspirin	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants
Warfarin	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Non vitamin K antagonist	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Other anticoagulant	11 participants n=5 Participants	3 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Outcome measures

Outcome measures
Measure	Vanoxerine HCl n=26 Participants Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose Vanoxerine HCl	Placebo n=15 Participants identically matching placebo capsules, orally, single-dose Placebo
Conversion to Sinus Rhythm	18 participants	3 participants

SECONDARY outcome

Timeframe: 8 days

Outcome measures

Outcome measures
Measure	Vanoxerine HCl n=20 Participants Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose Vanoxerine HCl	Placebo n=12 Participants identically matching placebo capsules, orally, single-dose Placebo
Length of Stay (From Time of Study Drug Administration)	4.7 days Standard Deviation 3.2	4.2 days Standard Deviation 2.9

Adverse Events

Vanoxerine HCl

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vanoxerine HCl n=26 participants at risk Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose Vanoxerine HCl	Placebo n=15 participants at risk identically matching placebo capsules, orally, single-dose Placebo
Cardiac disorders polymorphic ventricular tachycardia	11.5% 3/26 • Number of events 3	0.00% 0/15
Cardiac disorders torsades de pointes	3.8% 1/26 • Number of events 1	0.00% 0/15

Other adverse events

Adverse event data not reported

Additional Information

Chief Medical Officer

Laguna Pharmaceuticals

Phone: 858-405-1429

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place