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Study of the Electrocardiographic Effects of Ranolazine, Dofetilide, Verapamil, and Quinidine in Healthy Subjects

NCT01873950 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-03-08

Study results available
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Summary

This study seeks to compare 4 known QT prolonging drugs versus placebo to determine their effects on electrophysiological and other clinical parameters. The underlying purpose is to determine if depolarization and repolarization effects caused by drugs with differing ionic channel mechanisms can be distinguished from one another, and to gauge the sensitivity and specificity of novel signal analyses for detection of depolarization and repolarization changes. Secondarily, to evaluate the exposure response relationship and drug induced effects on the heart rate biomarker relationship.

Conditions

  • Drug-induced Surface ECG Changes

Interventions

DRUG

Ranolazine

DRUG

Dofetilide

DRUG

Verapamil

DRUG

Quinidine sulfate

DRUG

Placebo

Sponsors & Collaborators

  • Spaulding Clinical Research LLC

    collaborator OTHER

  • Food and Drug Administration (FDA)

    lead FED

Principal Investigators

  • Carlos Sanabria, MD · Spaulding Clinical Research LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-07-31
Completion
2014-12-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01873950 on ClinicalTrials.gov