Recent Updates
Recently added Catalysts

MK0524

Phase 2

Asthma | Small molecule | Respiratory |Merck & Company, Inc.|Trials Updated: Dec 22, 2015

MK0524 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Sep 2007

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment896

FDA Designations

No designations recorded

MK0524 clinical trials

MK0524 · 2 trials · 2 indications

Phase 2 2
NCT00783601MK0524 Asthma POC Study (0524-008)(COMPLETED)Asthma
COMPLETED130 Analytics
NCT00533208MK0524 Seasonal Allergic Rhinitis Study (0524-005)(COMPLETED)Seasonal Allergies
COMPLETED766 Analytics
PHASE2COMPLETED
MK0524 Asthma POC Study (0524-008)(COMPLETED)
AsthmaUnlock trial analytics
PHASE2COMPLETED
MK0524 Seasonal Allergic Rhinitis Study (0524-005)(COMPLETED)
Seasonal AllergiesUnlock trial analytics

Study Endpoints

Primary Endpoints

To demonstrate benefits of MK0524 compared with placebo on Forced Expiratory Volume in 1 second (FEV1)
Last 2 weeks of each treatment period

Secondary Endpoints

To determine the benefits of MK0524 as compared with placebo on the key secondary endpoints (Daytime & Nighttime Asthma Symptoms scores
Last 2 weeks of each treatment period
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALTreatment Sequence 1: MK0524 + placebo, MK0524 + montelukast, placebo, placebo, placebo + montelukast
2EXPERIMENTALTreatment sequence 2: Placebo, montelukast, placebo, MK0524, MK0524 + montelukast

Interventions

NameTypeDescription
Comparator: MK0524 + placeboDRUGTwo 150 mg MK0524 tablets + one placebo tablet in the matching image of montelukast 10 mg once daily for 3 weeks
Comparator: MK0524 + montelukastDRUGTwo 150 mg MK0524 tablets and one 10 mg montelukast tablet once daily for 2 weeks
Comparator: placebo + montelukastDRUGTwo placebo tablets in the matching image of MK0524 150 mg and one 10 mg tablet montelukast once daily for 2 weeks
Comparator: PlaceboDRUGDuring the double-blind treatment periods, patients receive either two placebo tablets in the matching image of MK0524 150 mg or one placebo tablet in the matching image of montelukast 10 mg in a crossover manner. During the washout period before the crossover to the opposite treatment sequence, patients receive two placebo tablets in the matching image of MK0524 150 mg and one placebo tablet in the matching image of montelukast 10 mg once daily for two weeks.
MK0524DRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Has symptoms of chronic asthma (shortness of breath, wheezing, chest tightness, etc.) for at least 1 year * Nonsmoker for at least 1 year with a smoking history of no more than 7 pack-years (i.e., 1 pack per day for 7 years) Exclusion Criteria: * Any clinically significant d...

Unlock Eligibility Criteria

Frequently asked questions about MK0524

What is MK0524 used for?

MK0524 is an investigational small molecule being studied for asthma and seasonal allergies. It has been evaluated in Phase 2 clinical trials in adults with these respiratory and allergic conditions. It is not approved for any indication and remains in clinical development.

Who is developing MK0524?

MK0524 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck sponsored the Phase 2 clinical studies of the drug in asthma and seasonal allergic rhinitis.

What phase is MK0524 in?

MK0524 is in Phase 2 clinical development. Both of its reported trials were Phase 2 studies, and both have been completed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is MK0524 in?

MK0524 has been studied in two completed Phase 2 trials. NCT00783601 was an asthma proof-of-concept study with 130 participants, and NCT00533208 was a seasonal allergic rhinitis study with 766 participants. Both enrolled adults and were randomized, double-blind, and controlled.

How many patients were enrolled in MK0524 trials?

The MK0524 clinical program enrolled 766 participants in total across its two completed Phase 2 studies. The seasonal allergic rhinitis trial, NCT00533208, accounted for all 766 enrolled participants, while the asthma proof-of-concept trial, NCT00783601, enrolled 130.

Is MK0524 a small molecule drug?

Yes, MK0524 is a small molecule therapeutic. It was developed by Merck & Company, Inc. and studied in Phase 2 trials for asthma and seasonal allergies. Both trials have been completed, and no active trials are currently listed for the asset.