Clinical trial NCT01228019: Niacin (+) Laropiprant (TREDAPTIVE) Re-examination Study (MK-0524A-119)
Official title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of TREDAPTIVE Tablet in Usual Practice
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hypercholesterolemia
Mixed Dyslipidemia
Keywords: Usual practice re-examination
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-10-25
Enrollment: 1166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Korean participants with hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE) for the first time

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.


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

Primary outcomes:
measure: Percentage of Participants With Any Adverse Experience
timeFrame: From start of treatment through 14 days after the last dose (Up to 26 weeks)
measure: Percentage of Participants With Adverse Drug Reactions
timeFrame: From start of treatment through 14 days after the last dose (Up to 26 weeks)
measure: Change From Baseline in Total Cholesterol at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Triglycerides at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Total Cholesterol at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Triglycerides at Week 24
timeFrame: Baseline and Week 24
measure: Investigator's Overall Efficacy Evaluation at Week 12
timeFrame: Baseline and Week 12
measure: Investigator's Overall Efficacy Evaluation at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: