A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158)
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ClinicalTrials.gov 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
|
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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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 |
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 |
Resource links provided by the National Library of Medicine

Genetics Home Reference related topics:
Hypercholesterolemia
MedlinePlus related topics:
Cholesterol
Cholesterol Levels: What You Need to Know
Cholesterol Medicines
U.S. FDA Resources
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
:
- Plasma Area Under the Concentration Curve From 0 to Infinity (AUC0-∞) of Laropiprant [ Time Frame: Predose Day 1 up to 24 hours postdose ]
- Plasma Maximum Concentration (Cmax) of Laropiprant [ Time Frame: Predose on Day 1 up to 48 hours postdose ]
- Total Urinary Excretion of Niacin and Niacin Metabolites [ Time Frame: Predose on Day 1 up to 72 hours postdose ]
- Plasma Cmax of Nicotinuric Acid (NUA) [ Time Frame: Predose on Day 1 up to 48 hours postdose ]
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Ages Eligible for Study: | 10 Years to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
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
No Contacts or Locations Provided
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT01583647 History of Changes |
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:
Hypercholesterolemia Hyperlipoproteinemia Type II Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Lipid Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Hyperlipoproteinemias 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 |