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MK0633

Phase 2

Atherosclerosis | Small molecule | Cardiovascular |Merck & Company, Inc.|Last Updated: Jan 22, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment180

FDA Designations

No designations recorded

Clinical trial landscape

MK0633 · 4 trials · 2 indications

Phase 2 1Phase 1 3
NCT00421278The Effect of MK 0633 in Patients With Atherosclerosis (0633-008)(COMPLETED)Atherosclerosis
COMPLETED180 Analytics
PHASE2COMPLETED
The Effect of MK 0633 in Patients With Atherosclerosis (0633-008)(COMPLETED)
AtherosclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the effects of the drug, MK 0633, on an inflammatory marker in your blood that may affect the plaque in the arteries, know as atherosclerosis
4 Weeks
To evaluate the safety and tolerability of MK0633 in adolescent asthma patients based on any clinical or laboratory adverse experiences
1 day
To evaluate the safety and tolerability of single oral doses of MK0633 in pediatric asthma patients.
Physical examinations, vital sign measurements, laboratory safety tests (blood chemistry, hematology and urinalysis), urine ß-hCG test, and 12-lead ECGs will be performed at various scheduled time points throughout the study.
To evaluate the safety and tolerability of MK0633 in adolescent asthma patients.
Blood and urine samples will be collected at specified intervals for 72 hours after study drug administration.

Secondary Endpoints

To obtain information on plasma pharmacokinetics (e.g., AUC0-inf, Cmax, Tmax, apparent t½,) of MK0633 after a single oral dose administration in pediatric asthma patients
Plasma will be analyzed at specific time-points for MK0633 concentrations. Urine will be collected for the measurement of LTE4 concentration.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
1EXPERIMENTALArm 1: Drug

Interventions

NameTypeDescription
MK0633DRUGSingle dose MK0633 100mg po in the fed state administered during a 4-wk study.
Comparator: MK0633DRUGA single dose of MK0633 10 mg or 25 mg film coated tablet. Dose will be based on patient weight.
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Eligibility Criteria

Age Range40 Years to 85 Years
SexMALE
Healthy VolunteersNo

Inclusion Criteria: * Patients with plaque in coronary or leg arteries, known as atherosclerosis or peripheral vascular disease * Inflammatory marker found in your blood, known as hsCRP \> 0.5 mg/L Exclusion Criteria: * Age \< 40 or \> 85 * Female * Heart attack, coronary artery bypass, stroke or...

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Frequently asked questions about MK0633

What is MK0633 used for?

MK0633 is an investigational small molecule being studied for asthma and atherosclerosis. Clinical trials have evaluated the drug in patients with atherosclerosis and in asthmatic children. It is not approved and remains in clinical development.

Who makes MK0633?

MK0633 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. The company has sponsored clinical trials of the drug in asthma and atherosclerosis.

What phase is MK0633 in?

MK0633 is in Phase 1 clinical development. Completed trials include Phase 1 studies in asthmatic children and a Phase 2 study in atherosclerosis. The drug remains investigational and has not been approved.

What clinical trials is MK0633 in?

MK0633 has been studied in several completed trials, including NCT00421278 in atherosclerosis, NCT00646789 and NCT00751413 in asthmatic children, and NCT00768170 in Japanese asthmatic children. All trials are completed.

Is MK0633 the same as 0633?

MK0633 is also referred to as 0633 in clinical trial titles. For example, the atherosclerosis trial is titled "The Effect of MK 0633 in Patients With Atherosclerosis (0633-008)." Both names refer to the same drug.