NCT02489331

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 193 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Dyslipidemias

Timeline

• Start date: 2015-07-01
• Primary completion: 2020-11-10
• Completion: 2020-11-10
• First posted: 2015-07-03
• Last updated: 2020-11-12

Locations

10 sites across 1 country: South Korea