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

Merck Sharp & Dohme (MSD)

Status: Terminated

Conditions: Mixed Dyslipidemia; Hypercholesterolemia

Treatments: Drug: Niacin (+) laropiprant

Study type: Observational

Funder types: Industry

Identifiers

NCT01228019

0524A-119

Details and patient eligibility

About

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.

Enrollment: 1,166 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,166 participants in 1 patient group

All participants

Description:

Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)

Treatment:

Drug: Niacin (+) laropiprant