Last updated: 11/03/2018 15:17:33
Regulatory Nebilet PMSNebilet PMS
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and effectiveness of Nebilet administered in Korean patients according to the prescribing information
Trial description: An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and effectiveness of Nebivolol administered in Korean patients according to the prescribing information
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of adverse events after Nebivolol administration
Timeframe: 3months, 6months
Secondary outcomes:
Occurrence of unexpected or serious adverse event after Nebivolol administration and effectiveness of Occurrence of unexpected or serious adverse event after Nebivolol administration and effectiveness of Nebivolol
Timeframe: 3 months, 6months
Interventions:
Drug: Nebivolol
Enrollment:
743
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Hypertension, Heart Failure
Product
nebivolol
Collaborators
Not applicable
Study date(s)
October 2009 to January 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
No
- All subjects must satisfy the following criteria at PMS entry according to KFDA PMS regulation:
- Subjects with indication in the prescribing information
Inclusion and exclusion criteria
Inclusion criteria:
- All subjects must satisfy the following criteria at PMS entry according to KFDA PMS regulation:
- Subjects with indication in the prescribing information
- Subjects administrated Nebivolol by physician’s decision
- Subjects with no contraindication according to the prescribing information
Trial location(s)
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
2011-08-01
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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