Niacin (+) Laropiprant (TREDAPTIVE) Re-examination Study (MK-0524A-119 AM2)

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: May 23, 2013
Last verified: May 2013
  Purpose

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 Intervention
Hypercholesterolemia
Mixed Dyslipidemia
Drug: Niacin (+) laropiprant

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]
  • Investigator's overall efficacy evaluation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 1137
Study Start Date: December 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01228019     History of Changes
Other Study ID Numbers: 0524A-119
Study First Received: October 22, 2010
Last Updated: May 23, 2013
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 23, 2014