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Odiparcil QT Definitive Study

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ClinicalTrials.gov Identifier: NCT00437242
Recruitment Status : Terminated
First Posted : February 19, 2007
Last Update Posted : June 4, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This study is being completed to demonstrate the lack of effect of repeat dosing with Odiparcil on the QTc interval.

Condition or disease Intervention/treatment Phase
Fibrillation, Atrial Atrial Fibrillation Drug: Odiparcil Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Effect of Repeat Oral Doses of Odiparcil on Cardiac Conduction as Assessed by 12-lead Electrocardiogram Compared to Placebo and a Single Oral Dose of Moxifloxacin.
Study Start Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. demonstrate lack of effect of repeat dose on QT interval with ECG measured on Days -1, 5 and 6 at 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 16, 18, 20 and 24 hours

Secondary Outcome Measures :
  1. Pharmacokinetics, CMAX, AUC, TMAX, PK samples taken at 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 16, 18, 20 and 24 hours on days 5 and 6


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion:

  • Healthy volunteers

Exclusion:

  • Cardiac abnormalities
  • Hepatic or renal insufficiency
  • Anti-coagulant medications
  • Bleeding history

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437242


Locations
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78744
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00437242     History of Changes
Other Study ID Numbers: ITI103221
First Posted: February 19, 2007    Key Record Dates
Last Update Posted: June 4, 2012
Last Verified: March 2011

Keywords provided by GlaxoSmithKline:
interval,
atrial fibrillation
QT,
odiparcil,

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes