A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158 AM1)
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:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01583647
First received: April 20, 2012
Last updated: January 29, 2013
Last verified: January 2013
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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 Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group 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:
Chanarin-Dorfman syndrome
cholesteryl ester storage disease
Farber lipogranulomatosis
hypercholesterolemia
MedlinePlus related topics:
Cholesterol
U.S. FDA Resources
Further study details as provided by Merck:
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) |
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) |
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 |
| Genders Eligible for Study: | Both |
| 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
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01583647 History of Changes |
| Other Study ID Numbers: | 0524A-158, 2012-001443-49 |
| Study First Received: | April 20, 2012 |
| Last Updated: | January 29, 2013 |
| Health Authority: | Norway: Norwegian Medicines Agency United States: Food and Drug Administration |
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 Nicotinic Acids Niacinamide |
Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 13, 2013