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
Terminated (halted prematurely)
Terminated (halted prematurely)
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
Observational study model:
Not applicable
Primary completion date:
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Terminated/Withdrawn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
Terminated (halted prematurely)
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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