Last updated on December 2018

Post Marketing Surveillance of Safety and Efficacy for Cholib in Korean Patients Under the "New Drug Re-examination".

Brief description of study

Post marketing surveillance of safety and efficacy for Cholib in Korean patients under the "New Drug Re-examination"

Detailed Study Description

The objective of this surveillance is to identify problems and questions on Cholib and on the following matters under the condition that the investigational product is in use.

  1. Serious adverse event and adverse drug reaction profile
    • Death or a life-threatening condition
    • Hospitalization or prolonged hospitalization
    • Persistent or significant disability/incapacity
    • Congenital anomaly/birth defect
    • Other medically significant events
  2. Unexpected adverse event/adverse drug reaction profile
  3. Known adverse drug reaction profile
  4. Non-serious adverse drug reaction profile
  5. Other information related to the product safety
  6. Efficacy evaluation
  7. Study of extended follow-up Surveillance of the safety and efficacy of the subjects who received Cholib for long-term use at least 24 weeks.
  8. Study of special patient Analysis of specific patients such as elderly patients (65 years and above), patients with renal/hepatic disease

Clinical Study Identifier: NCT02489331

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Hankook Geneal Hospital

Jeju, Korea, Republic of
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Gujwa Clinic

Jeju, Korea, Republic of
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Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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