Regulatory Nebilet PMS | Clinical Trial

Key information

Conditions

Hypertension Cardiovascular Diseases Heart Diseases Heart Failure Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Seoul, 130-702, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nebivolol

Drug

patients administrated Nebivolol according to the prescribing information

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Acronym: Nebilet PMS

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2011
First posted: Mar 1, 2010
Registry last updated: May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed