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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01228019
• Other study ID #: 0524A-119
• Status: Terminated
• Phase: N/A
• First received: October 22, 2010
• Last updated: April 1, 2015
• Start date: December 2010
• Est. completion date: May 2013

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1166
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dyslipidemias
• Hypercholesterolemia
• Mixed Dyslipidemia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Primary	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)	Yes
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No