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MK0476, montelukast

Phase 3

Asthma, Bronchial | Small molecule | Respiratory |Organon & Co.|Last Updated: Aug 14, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment58
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00092105Study of MK0476 (Montelukast Sodium) and Effects on Asthma and Nasal Symptoms Upon Exposure to Cats (0476-256)PHASE3 COMPLETED 58 — — Apr 1, 2002Jan 28, 2003Aug 14, 2024 - —
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Study Endpoints
Primary Endpoints
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) 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
ModelCROSSOVER
PurposePREVENTION
Interventions
NameTypeDescription
MK0476, montelukast sodiumDRUG -
Comparator: placeboDRUG -
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Eligibility Criteria
Age Range15 Years — 55 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Increased sensitivity to cat allergen proven by positive allergy testing, and by decreased lung function and increased symptoms of allergic rhinitis (runny nose) upon exposure to cats. Exclusion Criteria: * Medical history of a lung disorder (other than asthma) or a recent u...

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