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

This study has been terminated.
(In HPS2-THRIVE, MK-0524A did not meet the primary efficacy objective and there was a significant increase in incidence of some types of non-fatal SAEs)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01228019
First received: October 22, 2010
Last updated: September 26, 2014
Last verified: September 2014

October 22, 2010
September 26, 2014
December 2010
May 2013   (final data collection date for primary outcome measure)
  • Percentage of Participants With Any Adverse Experience [ Time Frame: From start of treatment through 14 days after the last dose (Up to 26 weeks) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: From start of treatment through 14 days after the last dose (Up to 26 weeks) ] [ Designated as safety issue: Yes ]
    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 Total Cholesterol at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Serum cholesterol 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 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Serum HDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE
  • Change From Baseline in Triglycerides at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Serum triglyceride levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE
  • Change From Baseline in Total Cholesterol at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Serum LDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE
  • Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Serum HDL-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 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    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 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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.
  • Investigator's Overall Efficacy Evaluation at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    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.
  • Number of participants with any adverse experience [ Time Frame: From start of treatment through 14 days after the last dose ] [ Designated as safety issue: Yes ]
  • Number of participants with drug-related adverse experiences [ Time Frame: From start of treatment through 14 days after the last dose ] [ Designated as safety issue: Yes ]
  • Change from baseline in total cholesterol [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in low density lipoprotein (LDL) cholesterol [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in high density lipoprotein (HDL) cholesterol [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in triglycerides [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in total cholesterol [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in low density lipoprotein (LDL) cholesterol [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in high density lipoprotein (HDL) cholesterol [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in triglycerides [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Investigator's overall efficacy evaluation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Investigators will indicate whether a participant's condition has Improved, is Unchanged, or is Worsened
  • Investigator's overall efficacy evaluation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Investigators will indicate whether a participant's condition has Improved, is Unchanged, or is Worsened
Complete list of historical versions of study NCT01228019 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

  • Hypercholesterolemia
  • Mixed Dyslipidemia
Drug: Niacin (+) laropiprant
Niacin (+) laropiprant (TREDAPTIVE) prescribed according to the current local label
Other Name: MK-0524A
All participants
Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
Intervention: Drug: Niacin (+) laropiprant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1166
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01228019
0524A-119
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP