Last updated on May 2017

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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Yusun Ryu, BPharm

Chung Tae Hoon's Internal Medicine Clinic
Daegu, Korea, Republic of
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Yusun Ryu, BPharm

Hyundai Medical Clinic
Daegu, Korea, Republic of
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Yusun Ryu, BPharm

Dr. Koh's Internal Medicine Clinic
Daegu, Korea, Republic of
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Yusun Ryu, BPharm

SANGIN Clinic of Internal Medicine
Daegu, Korea, Republic of
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