NCT01691313

Brief Summary

Evaluate the safety and efficacy of a single oral dose of vanoxerine compared to placebo, in a dose modification manner, on the conversion of symptomatic atrial fibrillation (a-fib) or flutter of recent onset to normal sinus rhythm.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_2

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

December 22, 2015

Completed
Last Updated

December 22, 2015

Status Verified

November 1, 2015

Enrollment Period

10 months

First QC Date

September 20, 2012

Results QC Date

October 15, 2015

Last Update Submit

November 18, 2015

Conditions

Symptomatic Atrial FibrillationAtrial Flutter

Keywords

vanoxerineatrial fibrillationatrial fluttera-fib

Outcome Measures

Primary Outcomes (2)

  • Conversion to Sinus Rhythm

    proportion of subjects who convert to sinus rhythm through 4 hours after start of study drug

    baseline through 4 hours

  • Conversion to Sinus Rhythm

    proportion of subjects who convert to sinus rhythm through 24 hours after start of study drug

    baseline through 24 hours

Study Arms (4)

vanoxerine 200mg

EXPERIMENTAL

vanoxerine HCl 200mg single dose (2x 100 mg oral capsule)

Drug: Vanoxerine

placebo

PLACEBO COMPARATOR

placebo to match vanoxerine oral capsule

Drug: Placebo

vanoxerine 300mg

EXPERIMENTAL

vanoxerine HCl 300 mg single dose (3x 100mg oral capsules)

Drug: Vanoxerine

vanoxerine 400mg

EXPERIMENTAL

vanoxerine HCl 400 mg single dose (4x 100 mg oral capsules)

Drug: Vanoxerine

Interventions

VanoxerineDRUG

single oral dose

Also known as: GBR12909
vanoxerine 200mgvanoxerine 300mgvanoxerine 400mg
PlaceboDRUG

single oral dose

Also known as: Placebo to match vanoxerine
placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • provide written informed consent,
  • male or female 18 years of age or greater; women of child bearing potential must use adequate contraception
  • symptomatic AF/AFL for more than 3 hours and less than 7 days (168 hours), as dated by symptoms
  • AF/AFL documented by ECG at the start of study drug administration

You may not qualify if:

  • Systolic blood pressure \<100 mmHg.
  • Average heart rate \<50 bpm.
  • Average QTcF (Fridericia correction) \>440 ms.
  • Average QRS interval \>140 ms.
  • Paced atrial or ventricular rhythm on ECG.
  • Serum potassium \<3.5 meq/L (may be corrected prior to randomization).
  • Received another intravenous Class I or Class III antiarrhythmic drug within prior 3 days.
  • received amiodarone (oral or IV) in prior 3 months.
  • Clinical evidence or history of acute coronary syndrome within 30 days prior to randomization.
  • Aortic stenosis with aortic valve area equal to or less than 1.0 cm2.
  • Rheumatic mitral stenosis with valve area of \<1.5 cm2.
  • Untreated hyperthyroidism.
  • Acute pericarditis.
  • AF/AFL as a result of surgery within the last 7 days
  • History of failed electrical cardioversion
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Ashkelon, Israel

Location

Unknown Facility

Haifa, Israel

Location

Unknown Facility

Nazareth, Israel

Location

Unknown Facility

Safed, Israel

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

Related Publications (1)

  • Dittrich HC, Feld GK, Bahnson TD, Camm AJ, Golitsyn S, Katz A, Koontz JI, Kowey PR, Waldo AL, Brown AM. COR-ART: A multicenter, randomized, double-blind, placebo-controlled dose-ranging study to evaluate single oral doses of vanoxerine for conversion of recent-onset atrial fibrillation or flutter to normal sinus rhythm. Heart Rhythm. 2015 Jun;12(6):1105-12. doi: 10.1016/j.hrthm.2015.02.014. Epub 2015 Feb 12.

    PMID: 25684233RESULT

MeSH Terms

Conditions

Atrial FlutterAtrial Fibrillation

Interventions

vanoxerine

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Howard C. Dittrich
Organization
Laguna Pharmaceuticals, Inc.
HDittrich@lagunarx.com
858-405-1429

Study Officials

  • Howard C Dittrich, MD

    ChanRx Corp.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2012

First Posted

September 24, 2012

Study Start

November 1, 2012

Primary Completion

September 1, 2013

Study Completion

October 1, 2013

Last Updated

December 22, 2015

Results First Posted

December 22, 2015

Record last verified: 2015-11

Locations

RU(2)IL(4)