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Odiparcil QT Definitive Study

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00437242
First received: February 16, 2007
Last updated: May 31, 2012
Last verified: March 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Fibrillation, Atrial
Atrial Fibrillation
 Drug: Odiparcil
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 54
Study Start Date: October 2006
Intervention Details:
    Drug: Odiparcil
    Other Name: Odiparcil
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion:

  • Healthy volunteers

Exclusion:

  • Cardiac abnormalities
  • Hepatic or renal insufficiency
  • Anti-coagulant medications
  • Bleeding history
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437242

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00437242     History of Changes
Other Study ID Numbers: ITI103221
Study First Received: February 16, 2007
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 16, 2013