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

Terminated

• Conditions: Mixed Dyslipidemia; Hypercholesterolemia
• Interventions: Drug: Niacin (+) laropiprant

• Registration Number: NCT01228019
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-22
• Study First Submitted QC: 2010-10-22
• Study First Posted: 2010-10-25
• Study Start: 2010-12
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Results First Submitted: 2014-03-25
• Results First Submitted QC: 2014-03-25
• Results First Posted: 2014-04-25
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-01
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1166

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All participants	Niacin (+) laropiprant	Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Total Cholesterol at Week 12	Baseline and Week 12	Serum cholesterol levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE
Percentage of Participants With Any Adverse Experience	From start of treatment through 14 days after the last dose (Up to 26 weeks)	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.
Percentage of Participants With Adverse Drug Reactions	From start of treatment through 14 days after the last dose (Up to 26 weeks)	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.
Change From Baseline in Triglycerides at Week 12	Baseline and Week 12	Serum triglyceride levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12	Baseline and Week 12	Serum LDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12	Baseline and Week 12	Serum HDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE
Investigator's Overall Efficacy Evaluation at Week 12	Baseline and 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.
Change From Baseline in Total Cholesterol at Week 24	Baseline and Week 24	Serum cholesterol levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24	Baseline and Week 24	Serum LDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE
Change From Baseline in Triglycerides at Week 24	Baseline and Week 24	Serum triglyceride levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE
Investigator's Overall Efficacy Evaluation at Week 24	Baseline and 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.
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24	Baseline and Week 24	Serum HDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE