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

Merck Sharp & Dohme LLC1,166 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,166

Conditions

Hypercholesterolemia Mixed Dyslipidemia

Interventions

Niacin (+) laropiprantDRUG

Niacin (+) laropiprant (TREDAPTIVE) prescribed according to the current local label

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of Participants With Any Adverse Experience

An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the study drug, was also an adverse event.

Time frame: From start of treatment through 14 days after the last dose (Up to 26 weeks)

Percentage of Participants With Adverse Drug Reactions

An adverse drug reaction was an adverse event of which the relationship to the study drug could not be ruled out. An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the study drug, was also an adverse event.

Time frame: From start of treatment through 14 days after the last dose (Up to 26 weeks)

Change From Baseline in Total Cholesterol at Week 12

Serum cholesterol levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE

Time frame: Baseline and Week 12

Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

Serum LDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE

Time frame: Baseline and Week 12

Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12

Serum HDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.