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laropiprant/niacin

Phase 3

Hypercholesterolemia | Small molecule | Cardiovascular |Merck & Company, Inc.|Last Updated: Sep 2, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment646

FDA Designations

No designations recorded

Clinical trial landscape

laropiprant/niacin · 1 trial · 2 indications

Phase 3 1
NCT00536510Effect of MK0524A on Cholesterol Levels (0524A-048)Hypercholesterolemia
COMPLETED646 Analytics
PHASE3COMPLETED
Effect of MK0524A on Cholesterol Levels (0524A-048)
HypercholesterolemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks
12 weeks

Low Density Lipoprotein Cholesterol (LDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure \*100

Secondary Endpoints

Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks
12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALlaropiprant/niacin (MK0524A)
2PLACEBO_COMPARATORplacebo

Interventions

NameTypeDescription
laropiprant/niacin (MK0524A)DRUGTreatment Period 1: one 20mg/1g tablet laropiprant/niacin once daily for 4 weeks Treatment Period 2: two 20mg/1g tablets laropiprant/niacin once daily for 8 weeks. All patients will receive placebo for a 4 week run-in period before randomization
Comparator: placeboDRUGTreatment Period 1: one 20mg/1g tablet placebo to laropiprant/niacin once daily for 4 weeks Treatment Period 2: two 20mg/1g tablets of placebo to laropiprant/niacin once daily for 8 weeks. All patients will receive placebo for a 4 week run-in period before randomization.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patient is male or female between 18 and 70 years of age * Females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study Exclusion Criteria: * Patient has a history of not being able to take niacin or niacin-containin...

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Frequently asked questions about laropiprant/niacin

What is Laropiprant used for?

Laropiprant is an investigational small molecule being studied for hypercholesterolemia and rosacea. In hypercholesterolemia, it was evaluated for its effect on cholesterol levels, and in rosacea, it was studied in participants with moderate to severe erythematotelangiectatic rosacea. It is not approved and remains in clinical development.

Who makes Laropiprant?

Laropiprant is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company has sponsored clinical trials of the drug for hypercholesterolemia and rosacea.

What phase is Laropiprant in?

Laropiprant is in Phase 1 clinical development, based on a completed Phase 1 trial in rosacea. It has also been studied in a completed Phase 3 trial for hypercholesterolemia. The drug is investigational and not FDA approved.

What clinical trials is Laropiprant in?

Laropiprant has been studied in two completed trials. NCT00536510 was a Phase 3 trial in hypercholesterolemia and hyperlipidemia with 646 participants. NCT01451619 was a Phase 1 trial in moderate to severe erythematotelangiectatic rosacea with 60 participants.

Is Laropiprant the same as MK-0524?

Yes, Laropiprant is also known as MK-0524. In clinical trials, it has been referred to by this alternative name, such as in the study of Laropiprant (MK-0524) in participants with rosacea.