Regulatory Nebilet PMS

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01077661
• Collaborator: (none)
• Enrollment: 743
• Location: 1
• Duration (Months): 15
• Patients Per Site Per Month: 49.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Heart Failure	Drug: Nebivolol

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 Design

• Study Type: Observational
• Actual Enrollment: 743 participants
• Observational Model: Other
• Time Perspective: Prospective
• 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
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Patients administrated Nebivolol There is only one group. This group includes patients administrated Nebivolol	Drug: Nebivolol; patients administrated Nebivolol according to the prescribing information

Outcome Measures

Primary Outcome Measures

1. Occurrence of adverse events after Nebivolol administration [3months, 6months]

Secondary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• 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

• Subjects administrated Nebivolol by physician's decision

• Subjects with no contraindication according to the prescribing information

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Seoul		Korea, Republic of	130-702

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01077661
• Other Study ID Numbers: 113554
• First Posted: Mar 1, 2010
• Last Update Posted: May 30, 2017
• Last Verified: May 1, 2017

• Keywords provided by GlaxoSmithKline: Nebivolol; PMS (post-marketing surveillance)
• Additional relevant MeSH terms: Heart Failure; Nebivolol

Study Results

No Results Posted as of May 30, 2017