Last updated: 11/03/2018 12:55:27
Drug Use Investigation for IMURAN tablet (heart transplant)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Drug Use Investigation for IMURAN tablet (heart transplant)
Trial description: This post-marketing surveillance (PMS) is conducted to evaluate the efficacy and safety of azathioprine tablets after heart transplant under conditions of actual use.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Onset status of rejection
Timeframe: 1 year
Subject’s survival or death
Timeframe: 1 year
Incidence of adverse events related to azathioprine tablets
Timeframe: 1 year
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
0
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
antirejection
Product
azathioprine
Collaborators
Not applicable
Study date(s)
May 2011 to May 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
none
- Patients who underwent heart transplant
- Azathioprine tablet was administered
- Not applicable
Inclusion and exclusion criteria
Inclusion criteria:
- Patients who underwent heart transplant
- Azathioprine tablet was administered
Exclusion criteria:
- Not applicable
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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