- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01077661
Regulatory Nebilet PMS (Nebilet PMS)
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 Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Seoul, Korea, Republic of, 130-702
- GSK Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients administrated Nebivolol
There is only one group.
This group includes patients administrated Nebivolol
|
patients administrated Nebivolol according to the prescribing information
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of adverse events after Nebivolol administration
Time Frame: 3months, 6months
|
3months, 6months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 months, 6months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Heart Failure
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Adrenergic Agonists
- Adrenergic beta-Agonists
- Adrenergic beta-1 Receptor Agonists
- Nebivolol
Other Study ID Numbers
- 113554
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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