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Regulatory Nebilet PMS

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01077661
First received: February 25, 2010
Last updated: March 10, 2011
Last verified: March 2011
  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: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01077661     History of Changes
Other Study ID Numbers: 113554
Study First Received: February 25, 2010
Last Updated: March 10, 2011
Health Authority: Korea: Korea Food & Drug Administration

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

Additional relevant MeSH terms:
Heart Failure
Hypertension
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Nebivolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 27, 2014