Niacin (+) Laropiprant (TREDAPTIVE) Re-examination Study (MK-0524A-119)

• Status: Terminated
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This survey is being conducted to assess the safety and efficacy of niacin (+) laropiprant (TREDAPTIVE) in usual practice in Korea according to the new product re-examination regulations of the Korean Food and Drug Administration.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Niacin; Niacinamide; Nicotinic Acids

Criteria

Inclusion Criteria:

• Participants who are treated with TREDAPTIVE tablet within current local label for the first time

• Participants with primary hypercholesterolemia or mixed dyslipidemia

• Participants who are treated with TREDAPTIVE for more than or equal to 24 weeks will be included in long-term surveillance

• Special participants with known hepatic disorder or renal disorder, participants 65 years old or older, participants younger than 19 years old, and pregnant woman will be evaluated if collected.

Exclusion Criteria:

• Participant who is treated with TREDAPTIVE tablet before contract and out of enrollment period

• Participant who has a contraindication to TREDAPTIVE tablet according to the current local label