NCT01480336

Brief Summary

The purpose of this study is to learn if combination therapy with amiodarone and ranolazine (an approved drug for chest pain) can help prevent arrhythmias.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 28, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

March 19, 2013

Status Verified

March 1, 2013

Enrollment Period

1.9 years

First QC Date

November 23, 2011

Last Update Submit

March 18, 2013

Conditions

Arrhythmia

Keywords

Arrhythmia

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic Parameter Estimates

    Absorption, Peak concentration, time to peak concentration, clearance, area under the curve

    12 hours

Secondary Outcomes (1)

  • Electrocardiogram (ECG)

    12 hours

Study Arms (2)

Amiodarone with Placebo

PLACEBO COMPARATOR
Drug: Amiodarone with Placebo

Amiodarone with Ranolazine

ACTIVE COMPARATOR
Drug: Amiodarone Plus Ranolazine

Interventions

Amiodarone Plus RanolazineDRUG

Ranolazine 500mg by mouth twice daily

Amiodarone with Ranolazine
Amiodarone with PlaceboDRUG

stabel dose of amiodarone as prescribed by cardiologist

Amiodarone with Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with an ICD who were on a stable dose of amiodarone for the past 60 days

You may not qualify if:

  • Patients with a life expectancy of less than 6 months
  • Patients with moderate or severe hepatic impairment (Child-Pugh Classes B or C) or requiring hemodialysis.
  • Pregnancy or lactation.
  • Treatment with potent CYP3A inhibitors, including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, indinavir, and saquinavir
  • Treatment with CYP3A inducers, including rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

AmiodaroneRanolazine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperazinesHeterocyclic Compounds, 1-Ring

Study Officials

  • William Baker, Pharm.D.

    University of Connecticut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2011

First Posted

November 28, 2011

Study Start

February 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

March 19, 2013

Record last verified: 2013-03

Locations

US(1)