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A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01583647
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 : April 24, 2012
Results First Posted : December 4, 2013
Last Update Posted : November 3, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study is to determine the pharmacokinetics of laropiprant following administration of a single dose of 1 (Panel A) and 2 (Panel B) combination tablets of MK-0524A in adolescents with heterozygous familial hypercholesterolemia.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia, Familial Heterozygous Familial Hypercholesterolemia Drug: MK-0524A Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ER Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia
Study Start Date : June 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: MK-0524A 1 g/20 mg (Panel A)
Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
Drug: MK-0524A
1 tablet of MK-0524A (1g ER niacin/20mg laropripant) orally
Other Name: Extended-release (ER) Niacin/Laropiprant

Experimental: MK-0524A 2 g/40 mg (Panel B)
Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
Drug: MK-0524A
2 tablets of MK-0524A (1g ER niacin/20mg laropripant) orally
Other Name: Extended-release (ER) Niacin/Laropiprant

Primary Outcome Measures :
  1. Plasma Area Under the Concentration Curve From 0 to Infinity (AUC0-∞) of Laropiprant [ Time Frame: Predose Day 1 up to 24 hours postdose ]
  2. Plasma Maximum Concentration (Cmax) of Laropiprant [ Time Frame: Predose on Day 1 up to 48 hours postdose ]
  3. Total Urinary Excretion of Niacin and Niacin Metabolites [ Time Frame: Predose on Day 1 up to 72 hours postdose ]
  4. Plasma Cmax of Nicotinuric Acid (NUA) [ Time Frame: Predose on Day 1 up to 48 hours postdose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Post-pubescent adolescent age 10 to 16 with heterozygous familial hypercholesterolemia
  • Agree to use (and/or have their partner use) acceptable methods of birth control beginning at the prestudy visit until at least 2 weeks after dosing of study drug
  • Height and weight fall between the 10th and 95th percentile for age with a minimum body weight of 23 kg
  • Receiving appropriate medical care for hypercholesterolemia, such as a statin or other lipid-modifying therapy.

Exclusion Criteria:

  • History of psychiatric or personality disorders that may affect the patient's ability to participate
  • History of stroke, chronic seizures, or major neurological disorder
  • History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases (excluding lipid abnormalities)
  • Poorly controlled or recently diagnosed Type 1 or Type 2 diabetes mellitus
  • History of neoplastic disease within previous 5 years
  • Consumes alcohol or excessive amounts of products that contain caffeine (e.g. cola)
  • Has had major surgery, donated and/or received blood within previous 8 weeks
  • Participated in another investigational study within previous 4 weeks
  • History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
  • Positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
  • Cannot swallow large tablets
  • Pregnant or breastfeeding
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01583647    
Other Study ID Numbers: 0524A-158
2012-001443-49 ( EudraCT Number )
First Posted: April 24, 2012    Key Record Dates
Results First Posted: December 4, 2013
Last Update Posted: November 3, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type II
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Nicotinic Acids
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs