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.)

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT01583647

First received: April 20, 2012

Last updated: November 2, 2015

Last verified: November 2015

History of Changes

Purpose

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 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:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Niacin Niacinamide

U.S. FDA Resources

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 ]
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 ]


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

Eligibility


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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT01583647 History of Changes
Other Study ID Numbers:	0524A-158 2012-001443-49 ( EudraCT Number )
Study First Received:	April 20, 2012
Results First Received:	October 7, 2013
Last Updated:	November 2, 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

ClinicalTrials.gov processed this record on June 27, 2017

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