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Regulatory Nebilet PMS (Nebilet PMS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01077661
First Posted: March 1, 2010
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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 Intervention
Hypertension Heart Failure Drug: Nebivolol

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of adverse events after Nebivolol administration [ Time Frame: 3months, 6months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 743
Study Start Date: October 2009
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients administrated Nebivolol
There is only one group. This group includes patients administrated Nebivolol
Drug: Nebivolol
patients administrated Nebivolol 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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
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
Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 130-702
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01077661     History of Changes
Other Study ID Numbers: 113554
First Submitted: February 25, 2010
First Posted: March 1, 2010
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by GlaxoSmithKline:
Nebivolol
PMS (post-marketing surveillance)

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular 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