| Trial ID: | L7315 |
| Source ID: | NCT01294553
|
| Associated Drug: |
Administration Of Rosiglitazone/Metformin
|
| Title: |
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of AVANDAMET Between June 2004 and January 2010
|
| Acronym: |
AVANDAMETPMS
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01294553/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Administration of rosiglitazone/metformin
|
| Outcome Measures: |
Primary: Number of Participants With an Adverse Event, An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, please see the table entitled "Other (non-serious) adverse events" in the Adverse Event section of the results record., 41.4 weeks | Secondary: Number of Participants With a Serious Adverse Event, A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, please see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record., 41.4 weeks|Number of Participants With the Indicated Unexpected Adverse Events, Unexpected adverse events are defined as those that were not described in the locally approved label by the Korean Food and Drug Administration (KFDA) at the time of surveillance completion., 41.4 weeks
|
| Sponsor/Collaborators: |
Sponsor: GlaxoSmithKline
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
717
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2004-06
|
| Completion Date: |
2010-01
|
| Results First Posted: |
2011-03-15
|
| Last Update Posted: |
2017-07-07
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT01294553
|
