Regulatory Nebilet PMS

GlaxoSmithKline743 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

743

Conditions

Hypertension Heart Failure

Interventions

NebivololDRUG

patients administrated Nebivolol according to the prescribing information

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

GSK Investigational Site

Seoul, South Korea

Outcomes

Primary Outcomes

Occurrence of adverse events after Nebivolol administration

Time frame: 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

Time frame: 3 months, 6months

Data from ClinicalTrials.gov

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