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

Contact Investigators or Research Sites near you

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Juyoung Park

Daesung Medical Center
Bucheon, Korea, Republic of
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Juyoung Park

Isam Clinic
Busan, Korea, Republic of
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Juyoung Park

DongRae BongSeng Hospital
Busan, Korea, Republic of
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Juyoung Park

Chung Tae Hoon's Internal Medicine Clinic
Daegu, Korea, Republic of
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Juyoung Park

Hyundai Medical Clinic
Daegu, Korea, Republic of
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Juyoung Park

Dr. Koh's Internal Medicine Clinic
Daegu, Korea, Republic of
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Juyoung Park

SANGIN Clinic of Internal Medicine
Daegu, Korea, Republic of
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Juyoung Park

New Seoul Internal Medicine, Radiology Clinics,
Daejeon, Korea, Republic of
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Juyoung Park

Kim Jong-hak Internal Medicine Clinic
Daejeon, Korea, Republic of
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Juyoung Park

Lee Jong-hyun Internal Medicine Clinic
Daejeon, Korea, Republic of
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Juyoung Park

Kim Tae Young Internal Medicine
Daejeon, Korea, Republic of
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Juyoung Park

Namyangju Hanyang General Hospital
Gyeonggi-do, Korea, Republic of
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Juyoung Park

Gyerim Internal Medicine Clinic
Gyeongju, Korea, Republic of
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Juyoung Park

Jeong Internal Medicine Clinic
Incheon, Korea, Republic of
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Juyoung Park

Hankook Geneal Hospital
Jeju, Korea, Republic of
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Juyoung Park

Gujwa Clinic
Jeju, Korea, Republic of
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Juyoung Park

Jeong Nae in Internal Medicine Clinic
Seoul, Korea, Republic of
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Juyoung Park

Sunchon Jungang Hospital
Suncheon, Korea, Republic of
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Juyoung Park

Kim Young Ho Internal Medicine Clinic
Gyeongsang, Korea, Republic of
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Recruitment Status: Open


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