Regulatory Nebilet PMS (Nebilet PMS)
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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. |
ClinicalTrials.gov Identifier: NCT01077661 |
Recruitment Status :
Completed
First Posted : March 1, 2010
Last Update Posted : May 30, 2017
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Condition or disease | Intervention/treatment |
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Hypertension Heart Failure | Drug: Nebivolol |
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 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 |

Group/Cohort | Intervention/treatment |
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Patients administrated Nebivolol
There is only one group. This group includes patients administrated Nebivolol
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Drug: Nebivolol
patients administrated Nebivolol according to the prescribing information |
- Occurrence of adverse events after Nebivolol administration [ Time Frame: 3months, 6months ]
- 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 ]

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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 |
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

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
Korea, Republic of | |
GSK Investigational Site | |
Seoul, Korea, Republic of, 130-702 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
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 |
Nebivolol PMS (post-marketing surveillance) |
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 |