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

ClinicalTrials.gov Identifier:

NCT01228019

First received: October 22, 2010

Last updated: May 23, 2013

Last verified: May 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	October 22, 2010
Last Updated Date	May 23, 2013
Start Date ^ICMJE	December 2010
Primary Completion Date	May 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 22, 2010)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01228019 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Niacin (+) Laropiprant (TREDAPTIVE) Re-examination Study (MK-0524A-119 AM2)
Official Title ^ICMJE	Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of TREDAPTIVE Tablet in Usual Practice
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Korean participants with hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE) for the first time
Condition ^ICMJE	Hypercholesterolemia Mixed Dyslipidemia
Intervention ^ICMJE	Drug: Niacin (+) laropiprant Niacin (+) laropiprant (TREDAPTIVE) prescribed according to the current local label Other Name: MK-0524A
Study Group/Cohort (s)	All participants Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE) Intervention: Drug: Niacin (+) laropiprant
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	1137
Completion Date	May 2013
Primary Completion Date	May 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01228019
Other Study ID Numbers ^ICMJE	0524A-119
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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