Last updated: 11/04/2018 08:28:15

Odiparcil QT definitive study

GSK study ID
ITI103221
Clinicaltrials.gov ID
NCT00437242
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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.
Trial description: This study is being completed to
demonstrate the lack of effect of repeat dosing with Odiparcil on the QTc interval.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: Odiparcil
    • Enrollment:
    54
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Fibrillation, Atrial
    Product
    odiparcil
    Collaborators
    Not applicable
    Study date(s)
    October 2006 to December 2006
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 60 years
    Accepts healthy volunteers
    Yes
    • Inclusion:
    • Healthy volunteers
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion:
    • Healthy volunteers Exclusion:
    • Cardiac abnormalities
    • Hepatic or renal insufficiency
    • Anti-coagulant medications
    • Bleeding history

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Austin, Texas, United States, 78744
    Status
    Terminated/Withdrawn
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    2006-18-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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