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

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.)
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: April 20, 2012
Last updated: December 1, 2014
Last verified: December 2014

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 Intervention Phase
Hypercholesterolemia, Familial
Heterozygous Familial Hypercholesterolemia
Drug: MK-0524A
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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

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 ] [ Designated as safety issue: No ]
  • Plasma Maximum Concentration (Cmax) of Laropiprant [ Time Frame: Predose on Day 1 up to 48 hours postdose ] [ Designated as safety issue: No ]
  • Total Urinary Excretion of Niacin and Niacin Metabolites [ Time Frame: Predose on Day 1 up to 72 hours postdose ] [ Designated as safety issue: No ]
  • Plasma Cmax of Nicotinuric Acid (NUA) [ Time Frame: Predose on Day 1 up to 48 hours postdose ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: June 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   10 Years to 16 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01583647     History of Changes
Other Study ID Numbers: 0524A-158, 2012-001443-49
Study First Received: April 20, 2012
Results First Received: October 7, 2013
Last Updated: December 1, 2014
Health Authority: Norway: Norwegian Medicines Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hyperlipoproteinemia Type II
Genetic Diseases, Inborn
Lipid Metabolism Disorders
Lipid Metabolism, Inborn Errors
Metabolic Diseases
Metabolism, Inborn Errors
Nicotinic Acids
Cardiovascular Agents
Growth Substances
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents
Vitamin B Complex
Vitamins processed this record on March 03, 2015