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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1166 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercholesterolemia Mixed Dyslipidemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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All participants

Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)

Niacin (+) laropiprant

Intervention Type DRUG

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

Interventions

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Niacin (+) laropiprant

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

Intervention Type DRUG

Other Intervention Names

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MK-0524A

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No