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MK0476, montelukast

Phase 3

Asthma, Bronchial | Small molecule | Respiratory |Organon & Co.|Last Updated: Aug 15, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment58

FDA Designations

No designations recorded

Clinical trial landscape

MK0476, montelukast · 2 trials · 3 indications

Phase 3 2
NCT00092885An Approved Drug to Study a New Indication for Seasonal Allergic Rhinitis in Patients With Asthma (0476-269)Rhinitis, Allergic, Seasonal
COMPLETED831 Analytics
NCT00092105Study of MK0476 (Montelukast Sodium) and Effects on Asthma and Nasal Symptoms Upon Exposure to Cats (0476-256)Asthma, Bronchial
COMPLETED58 Analytics
PHASE3COMPLETED
An Approved Drug to Study a New Indication for Seasonal Allergic Rhinitis in Patients With Asthma (0476-269)
Rhinitis, Allergic, SeasonalUnlock trial analytics
PHASE3COMPLETED
Study of MK0476 (Montelukast Sodium) and Effects on Asthma and Nasal Symptoms Upon Exposure to Cats (0476-256)
Asthma, BronchialUnlock trial analytics

Study Endpoints

Primary Endpoints

Daily Rhinitis Symptoms score; the Daytime Nasal Symptoms score and Nighttime Symptoms score
Co-Primary endpoints: (1) Area Under the Curve (AUC) for the percent fall from prechallenge FEV1 during allergen challenge; (2) Area Under the Curve for the increase from prechallenge Nasal Symptoms score during allergen challenge

Secondary Endpoints

(1) Rhinoconjunctivitis Quality-of-Life Questionnaire overall score; (2) Global Evaluation of Allergic Rhinitis by Patient; (3) Global Evaluation of Allergic Rhinitis by Physician
(1) Maximum percent fall from prechallenge FEV1; (2) AUC for the increase from prechallenge Chest Symptoms score (3) AUC for the increase from prechallenge Nasal Symptoms score collected over 60 minutes after terminating the challenge.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
MK0476, montelukast sodiumDRUG -
Comparator: placeboDRUG -
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Eligibility Criteria

Age Range15 Years to 85 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Non-smoker * A 2-year documented history of seasonal allergic rhinitis * A 1-year documented history of chronic asthma * Positive allergy testing Exclusion Criteria: * Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.

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Frequently asked questions about MK0476, montelukast

What is MK-0476 used for?

MK-0476, also known as montelukast, is a small molecule being studied for respiratory conditions including seasonal allergic rhinitis, bronchiolitis, and bronchial asthma. It is currently in Phase 2 clinical development for these indications.

What does MK-0476 target?

MK-0476 is a small molecule being developed for respiratory conditions. Its specific molecular target has not been disclosed in available clinical trial information.

Who makes MK-0476?

MK-0476 is being developed by Organon & Co., a company traded on the New York Stock Exchange under the ticker symbol OGN.

What phase is MK-0476 in?

MK-0476 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities for the conditions under study.

What clinical trials is MK-0476 in?

MK-0476 has been studied in completed clinical trials, including NCT00092105 for asthma and perennial allergic rhinitis, NCT00092885 for seasonal allergic rhinitis with asthma, and NCT00394069 for bronchiolitis in young children.

Is MK-0476 the same as montelukast?

Yes, MK-0476 is also known as montelukast. Clinical trials reference montelukast sodium as the study drug, and the compound is being evaluated for respiratory indications.