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

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