NCT01077661

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
743

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

February 25, 2010

Last Update Submit

May 25, 2017

Conditions

HypertensionHeart Failure

Keywords

NebivololPMS (post-marketing surveillance)

Outcome Measures

Primary Outcomes (1)

  • Occurrence of adverse events after Nebivolol administration

    3months, 6months

Secondary Outcomes (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

Study Arms (1)

Patients administrated Nebivolol

There is only one group. This group includes patients administrated Nebivolol

Drug: Nebivolol

Interventions

NebivololDRUG

patients administrated Nebivolol according to the prescribing information

Patients administrated Nebivolol

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients administrated Nebivolol at the site

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Seoul, 130-702, South Korea

Location

MeSH Terms

Conditions

HypertensionHeart Failure

Interventions

Nebivolol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHeart Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2010

First Posted

March 1, 2010

Study Start

October 1, 2009

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

KR(1)