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

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ClinicalTrials.gov Identifier: NCT02454283

Recruitment Status : Terminated (Cardiac safety finding)

First Posted : May 27, 2015

Results First Posted : October 17, 2016

Last Update Posted : October 17, 2016

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Laguna Pharmaceuticals, Inc.

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Atrial Fibrillation or Flutter
Interventions	Drug: Vanoxerine HCl Drug: Placebo
Enrollment	41

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Vanoxerine HCl	Placebo
Arm/Group Description	Vanoxerine HCl, 400 mg (2 x 200 mg ...	identically matching placebo capsul...
Arm/Group Description	Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose Vanoxerine HCl	identically matching placebo capsules, orally, single-dose Placebo
Period Title: Overall Study
Started	26	15
Completed	26	15
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Vanoxerine HCl	Placebo	Total
Arm/Group Description		Vanoxerine HCl, 400 mg (2 x 200 mg ...	identically matching placebo capsul...	Total of all reporting groups
Arm/Group Description		Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose Vanoxerine HCl	identically matching placebo capsules, orally, single-dose Placebo	Total of all reporting groups
Overall Number of Baseline Participants		26	15	41
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	26 participants	15 participants	41 participants
		68.1 (9.3)	66.9 (11.3)	67.7 (10.0)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	26 participants	15 participants	41 participants
	Female	5 19.2%	7 46.7%	12 29.3%
	Male	21 80.8%	8 53.3%	29 70.7%
Prior AF/AFL Measure Type: Number Unit of measure: Participants
	Number Analyzed	26 participants	15 participants	41 participants
		16	7	23
Hypertension Measure Type: Number Unit of measure: Participants
	Number Analyzed	26 participants	15 participants	41 participants
		16	11	27
Diabetes mellitus Measure Type: Number Unit of measure: Participants
	Number Analyzed	26 participants	15 participants	41 participants
		4	0	4
Hyperlipidemia Measure Type: Number Unit of measure: Participants
	Number Analyzed	26 participants	15 participants	41 participants
		8	6	14
COPD Measure Type: Number Unit of measure: Participants
	Number Analyzed	26 participants	15 participants	41 participants
		2	1	3
Hyperthyroidism Measure Type: Number Unit of measure: Participants
	Number Analyzed	26 participants	15 participants	41 participants
		1	0	1
Hypothyroidism Measure Type: Number Unit of measure: Participants
	Number Analyzed	26 participants	15 participants	41 participants
		3	0	3
Prior stroke Measure Type: Number Unit of measure: Participants
	Number Analyzed	26 participants	15 participants	41 participants
		0	2	2
Pacemaker Measure Type: Number Unit of measure: Participants
	Number Analyzed	26 participants	15 participants	41 participants
		1	0	1
Heart failure Measure Type: Number Unit of measure: Participants
	Number Analyzed	26 participants	15 participants	41 participants
		5	2	7
LVEF, mean Mean (Standard Deviation) Unit of measure: %
	Number Analyzed	26 participants	15 participants	41 participants
		54.3 (8.4)	55.1 (12.4)	54.6 (9.7)
Mitral stenosis Measure Type: Number Unit of measure: Participants
	Number Analyzed	26 participants	15 participants	41 participants
		0	0	0
Mitral regurgitation Measure Type: Number Unit of measure: Participants
	Number Analyzed	26 participants	15 participants	41 participants
		10	4	14
Aortic stenosis Measure Type: Number Unit of measure: Participants
	Number Analyzed	26 participants	15 participants	41 participants
		1	0	1
Aortic regurgitation Measure Type: Number Unit of measure: Participants
	Number Analyzed	26 participants	15 participants	41 participants
		4	1	5
Ischemic heart disease Measure Type: Number Unit of measure: Participants
	Number Analyzed	26 participants	15 participants	41 participants
		3	3	6
Prior revascularization (PCI or CABG) Measure Type: Number Unit of measure: Participants
	Number Analyzed	26 participants	15 participants	41 participants
		2	2	4
Prior antiarrhythmic drug therapy Measure Type: Number Unit of measure: Participants
	Number Analyzed	26 participants	15 participants	41 participants
		0	2	2
Prior catheter ablation of AF Measure Type: Number Unit of measure: Participants
	Number Analyzed	26 participants	15 participants	41 participants
		1	0	1
Aspirin Measure Type: Number Unit of measure: Participants
	Number Analyzed	26 participants	15 participants	41 participants
		5	2	7
Warfarin Measure Type: Number Unit of measure: Participants
	Number Analyzed	26 participants	15 participants	41 participants
		3	1	4
Non vitamin K antagonist Measure Type: Number Unit of measure: Participants
	Number Analyzed	26 participants	15 participants	41 participants
		4	2	6
Other anticoagulant Measure Type: Number Unit of measure: Participants
	Number Analyzed	26 participants	15 participants	41 participants
		11	3	14

Outcome Measures

1.Primary Outcome


Title	Conversion to Sinus Rhythm
Description	Conversion to sinus rhythm (or atrial paced rhythm in the case of subj...
Description	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.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Vanoxerine HCl	Placebo
Arm/Group Description:	Vanoxerine HCl, 400 mg (2 x 200 mg ...	identically matching placebo capsul...
Arm/Group Description:	Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose Vanoxerine HCl	identically matching placebo capsules, orally, single-dose Placebo
Overall Number of Participants Analyzed	26	15
Measure Type: Number Unit of Measure: participants
	18	3

2.Secondary Outcome


Title	Length of Stay (From Time of Study Drug Administration)
Description	[Not Specified]
Description	[Not Specified]
Time Frame	8 days

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Vanoxerine HCl	Placebo
Arm/Group Description:	Vanoxerine HCl, 400 mg (2 x 200 mg ...	identically matching placebo capsul...
Arm/Group Description:	Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose Vanoxerine HCl	identically matching placebo capsules, orally, single-dose Placebo
Overall Number of Participants Analyzed	20	12
Mean (Standard Deviation) Unit of Measure: days
	4.7 (3.2)	4.2 (2.9)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Vanoxerine HCl		Placebo
Arm/Group Description	Vanoxerine HCl, 400 mg (2 x 200 mg ...		identically matching placebo capsul...
Arm/Group Description	Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose Vanoxerine HCl		identically matching placebo capsules, orally, single-dose Placebo
All-Cause Mortality
	Vanoxerine HCl		Placebo
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	Vanoxerine HCl		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/26 (15.38%)		0/15 (0.00%)
Cardiac disorders
polymorphic ventricular tachycardia ^†	3/26 (11.54%)	3	0/15 (0.00%)	0
torsades de pointes	1/26 (3.85%)	1	0/15 (0.00%)	0
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Vanoxerine HCl		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0.00%)		0/15 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Chief Medical Officer
Organization:	Laguna Pharmaceuticals
Phone:	858-405-1429
EMail:	hdittrich@imager.com

Layout table for additonal information

Responsible Party:	Laguna Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT02454283
Other Study ID Numbers:	LGN-VN-003
First Submitted:	May 20, 2015
First Posted:	May 27, 2015
Results First Submitted:	August 23, 2016
Results First Posted:	October 17, 2016
Last Update Posted:	October 17, 2016

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