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Regulatory Nebilet PMS (Nebilet PMS)

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ClinicalTrials.gov Identifier: NCT01077661
Recruitment Status : Completed
First Posted : March 1, 2010
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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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
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
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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 : October 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Occurrence of adverse events after Nebivolol administration [ Time Frame: 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 [ Time Frame: 3 months, 6months ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients administrated Nebivolol at the site
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077661


Locations
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Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 130-702
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01077661    
Other Study ID Numbers: 113554
First Posted: March 1, 2010    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Keywords provided by GlaxoSmithKline:
Nebivolol
PMS (post-marketing surveillance)
Additional relevant MeSH terms:
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Heart Failure
Cardiovascular Diseases
Heart Diseases
Nebivolol
Antihypertensive Agents
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
 Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs