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MK0633

Phase 2

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

MK0633 development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Nov 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials4
Total Enrollment224

FDA Designations

No designations recorded

MK0633 clinical trials

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?

MK0633 is an investigational small molecule developed by Merck & Company, Inc. (MRK). It has been studied in clinical trials for asthma and atherosclerosis. MK0633 remains in clinical development and is not approved for any indication. The program's trials are all listed as completed, with no active studies currently recruiting.

What is MK0633 used for in asthma?

MK0633 was studied in Phase 1 trials in asthmatic children, including single dose and plasma level studies in patients aged 6 to less than 16 years. It was also evaluated in a Phase 2 study in patients with atherosclerosis. MK0633 is investigational and has not been approved for treating asthma or any other condition.

Who makes MK0633?

MK0633 is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the clinical trials of MK0633 in asthma and atherosclerosis. The drug remains an investigational asset in the company's pipeline rather than an approved commercial product.

What phase is MK0633 in?

MK0633 has been tested in Phase 1 and Phase 2 clinical trials. The Phase 1 studies were conducted in asthmatic children, while a Phase 2 study evaluated MK0633 in patients with atherosclerosis. All of these trials are completed, and no active trials are currently listed for MK0633.

What clinical trials is MK0633 in?

MK0633 has been evaluated in completed trials including NCT00768170, a single dose study in Japanese asthmatic children aged 12 to less than 16 years; NCT00751413, which measured plasma levels in children ages 6 to 12; NCT00646789, a safety and tolerability study in asthmatic children; and NCT00421278, a Phase 2 atherosclerosis study.

Is MK0633 the same as Comparator: MK0633?

Yes. MK0633 is also referred to as Comparator: MK0633. Both names refer to the same investigational small molecule developed by Merck & Company, Inc. (MRK) and studied in asthma and atherosclerosis trials.