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

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ClinicalTrials.gov Identifier: NCT01228019
Recruitment Status : 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)
First Posted : October 25, 2010
Results First Posted : April 25, 2014
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Hypercholesterolemia Mixed Dyslipidemia Drug: Niacin (+) laropiprant

Study Design

Study Type : Observational
Actual Enrollment : 1166 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of TREDAPTIVE Tablet in Usual Practice
Study Start Date : December 2010
Primary Completion Date : May 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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 Name: MK-0524A


Outcome Measures

Primary Outcome Measures :
  1. Percentage of Participants With Any Adverse Experience [ Time Frame: 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.

  2. Percentage of Participants With Adverse Drug Reactions [ Time Frame: 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.

  3. Change From Baseline in Total Cholesterol at Week 12 [ Time Frame: Baseline and Week 12 ]
    Serum cholesterol levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE

  4. Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]
    Serum LDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE

  5. Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]
    Serum HDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE

  6. Change From Baseline in Triglycerides at Week 12 [ Time Frame: Baseline and Week 12 ]
    Serum triglyceride levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE

  7. Change From Baseline in Total Cholesterol at Week 24 [ Time Frame: Baseline and Week 24 ]
    Serum cholesterol levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE

  8. Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 [ Time Frame: Baseline and Week 24 ]
    Serum LDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE

  9. Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 [ Time Frame: Baseline and Week 24 ]
    Serum HDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE

  10. Change From Baseline in Triglycerides at Week 24 [ Time Frame: Baseline and Week 24 ]
    Serum triglyceride levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE

  11. Investigator's Overall Efficacy Evaluation at Week 12 [ Time Frame: 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.

  12. Investigator's Overall Efficacy Evaluation at Week 24 [ Time Frame: 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Korean participants with hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE) for the first time
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
More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01228019     History of Changes
Other Study ID Numbers: 0524A-119
First Posted: October 25, 2010    Key Record Dates
Results First Posted: April 25, 2014
Last Update Posted: April 21, 2015
Last Verified: April 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Usual practice re-examination

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Niacin
Niacinamide
Nicotinic Acids
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs