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

TERMINATEDPHASE1

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

A Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ER Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia

NCT01583647•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

10 - 16 years

Sex

ALL

Healthy Volunteers

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)
+2 more criteria

Key Dates

Start Date

June 1, 2012

Primary Completion Date

December 1, 2012

Completion Date

December 1, 2012

Last Updated

November 3, 2015

Enrollment

ACTUAL participants

Conditions

Hypercholesterolemia, FamilialHeterozygous Familial Hypercholesterolemia

Interventions

MK-0524A

DRUG

MK-0524A

DRUG

A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)

NCT07058077

Heterozygous Familial Hypercholesterolemia (HeFH)

View study

RECRUITINGNA

Screening for Familial Hypercholesterolemia in Children

NCT06555120

Hypercholesterolemia, Familial

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RECRUITINGPHASE3

A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 3, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)

Screening for Familial Hypercholesterolemia in Children

A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia

Genetic Testing and Motivational Counseling for FH

A Study of VERVE-101 in Patients With Familial Hypercholesterolemia and Cardiovascular Disease

A Study of PCSK9 Inhibitor AK102 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)