Regulatory Nebilet PMS

Completed

• Conditions: Hypertension; Heart Failure
• Interventions: Drug: Nebivolol

• Registration Number: NCT01077661
• Lead Sponsor: GlaxoSmithKline

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-02-25
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-03-01
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 743

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients administrated Nebivolol	Nebivolol	There is only one group. This group includes patients administrated Nebivolol

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events after Nebivolol administration	3months, 6months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇰🇷 Seoul, Korea, Republic of