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

Study Overview
=================
Brief 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.

Official Title
-----------------
Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of TREDAPTIVE Tablet in Usual Practice

Conditions
-----------------
Hypercholesterolemia, Mixed Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Niacin (+) laropiprant


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br>Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE) | Drug: Niacin (+) laropiprant<br>* Niacin (+) laropiprant (TREDAPTIVE) prescribed according to the current local label<br>* Other names: MK-0524A;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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 | 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 | Baseline and Week 12 | 
| Change From Baseline in Triglycerides at Week 12 | Serum triglyceride levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE | Baseline and Week 12 | 
| Change From Baseline in Total Cholesterol at Week 24 | Serum cholesterol levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE | Baseline and Week 24 | 
| Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 | Serum LDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE | Baseline and Week 24 | 
| Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 | Serum HDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE | Baseline and Week 24 | 
| Change From Baseline in Triglycerides at Week 24 | Serum triglyceride levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE | Baseline and Week 24 | 
| Investigator's Overall Efficacy Evaluation at Week 12 | The investigator evaluated all available data after 12 weeks of TREDAPTIVE and assigned an overall evaluation of Improved, Unchanged or Worsened when compared to baseline. | Baseline and Week 12 | 
| Investigator's Overall Efficacy Evaluation at Week 24 | The investigator evaluated all available data after 24 weeks of TREDAPTIVE and assigned an overall evaluation of Improved, Unchanged or Worsened when compared to baseline. | Baseline and Week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Usual practice re-examination