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

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

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 Overview

• Status: Terminated
• Conditions: Hypercholesterolemia; Mixed Dyslipidemia
• Intervention / Treatment: Drug: Niacin (+) laropiprant

• Study Type: Observational
• Enrollment (Actual): 1166

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Korean participants with hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE) for the first time

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All participants; Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)	Drug: Niacin (+) laropiprant; Niacin (+) laropiprant (TREDAPTIVE) prescribed according to the current local label; 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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: October 22, 2010
• First Submitted That Met QC Criteria: October 22, 2010
• First Posted (Estimate): October 25, 2010

Study Record Updates

• Last Update Posted (Estimate): April 21, 2015
• Last Update Submitted That Met QC Criteria: April 1, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Usual practice re-examination
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Niacin
• Other Study ID Numbers: 0524A-119