Heart Failure, Hypertension
Conditions
Keywords
Nebivolol, PMS (post-marketing surveillance)
Brief summary
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
Detailed 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 Nebivolol will be administered to Hypertension or Chronic heart failure (CHF) patients as described the prescribing information of Nebivolol by physician's decision.
Interventions
DRUGNebivolol
patients administrated Nebivolol according to the prescribing information
Sponsors
GlaxoSmithKline
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events after Nebivolol administration | 3months, 6months |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 3 months, 6months |
Countries
South Korea
Outcome results
None listed