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MK0476, montelukast

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials9
Total Enrollment3,610

FDA Designations

No designations recorded

MK0476, montelukast clinical trials

MK0476, montelukast · 9 trials · 6 indications

Phase 3 6Phase 2 3
NCT00445107SINGULAIR (R) as Complementary Therapy to Fixed Association Regimen (0476-363)Asthma
COMPLETED198 Analytics
NCT00398151To Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy (0476-366)Asthma
COMPLETED58 Analytics
NCT00092144Study of an Approved Drug in Patients With Asthma (0476-289)(COMPLETED)Asthma
COMPLETED500 Analytics
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
NCT00489346A Study to Evaluate MK0476 and Fluticasone to Control Asthma in Patients With Mild Persistent Asthma (0476-910)Asthma, Bronchial
COMPLETED994 Analytics
PHASE3COMPLETED
SINGULAIR (R) as Complementary Therapy to Fixed Association Regimen (0476-363)
AsthmaUnlock trial analytics
PHASE3COMPLETED
To Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy (0476-366)
AsthmaUnlock trial analytics
PHASE3COMPLETED
Study of an Approved Drug in Patients With Asthma (0476-289)(COMPLETED)
AsthmaUnlock trial 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
PHASE3COMPLETED
A Study to Evaluate MK0476 and Fluticasone to Control Asthma in Patients With Mild Persistent Asthma (0476-910)
Asthma, BronchialUnlock trial analytics

Study Endpoints

Primary Endpoints

Change of the asthma control questionnaire scores taken over 8 weeks
Ltd4 in urine and eosinophil from peripheral blood over 3 months of therapy
To assess daytime asthma symptoms as measured by daily diaries over a 3-week treatment period
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
Improvement of asthma with MK0476 and Fluticasone as measured by number of asthma rescue-free days
Duration of Trial
To evaluate the safety and tolerability of montelukast oral granules in children aged 1 to 3 months.
The change from baseline in the composite nasal symptoms score (average over the 2-week treatment period) in seasonal allergic rhinitis
To evaluate the safety and tolerability of montelukast oral granules in children aged 3 to 6 months.
14 days

Secondary Endpoints

Asthma symptoms score throughout the study
To assess the following over a 3-week treatment period:
nighttime symptoms
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Montelukast sodiumEXPERIMENTALParticipants receive montelukast sodium for 14 days.

Interventions

NameTypeDescription
MK0476, montelukast sodium / Duration of Treatment: 8 WeeksDRUG -
MK0476, montelukast sodium / Duration of Treatment: 12 WeeksDRUG -
MK0476, montelukast sodium / Duration of Treatment: 4 weeksDRUG -
Comparator: placebo / Duration of Treatment: 4 weeksDRUG -
MK0476, montelukast sodiumDRUG -
Comparator: placeboDRUG -
MK0476, montelukast sodium / Duration of Treatment: 1 YearDRUG -
Comparator : fluticasone propionate / Duration of Treatment: 1 YearDRUG -
MK0476, Montelukast Sodium /Duration of Treatment : 14 DaysDRUG -
MK0476, montelukast sodium / Duration of Treatment: 2 WeeksDRUG -
Comparator: placebo / Duration of Treatment: 2 WeeksDRUG -
MK-0476, montelukast sodiumDRUGDuration of Treatment: 14 Days
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Eligibility Criteria

Age Range15 Years to 80 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patient is currently a nonsmoker and has been a nonsmoker for at least 1 year * Patient with clinical evidence of mild/moderate asthma with or without allergic rhinitis Exclusion Criteria: * Patient has been treated in an emergency room for asthma within 4 weeks or has been ...

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Frequently asked questions about MK0476, montelukast

What is MK-0476 (montelukast) used for?

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

Who makes MK-0476 (montelukast)?

MK-0476 (montelukast) is being developed by Organon & Co., a company traded under the ticker symbol OGN on the stock exchange. The drug is in Phase 2 clinical development for respiratory indications.

What phase is MK-0476 (montelukast) in?

MK-0476 (montelukast) is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials for this drug are ongoing or completed, with the most advanced completed trials being Phase 3 studies.

What clinical trials is MK-0476 (montelukast) in?

MK-0476 (montelukast) has been studied in clinical trials including NCT00092105, NCT00092885, and NCT00394069. These trials investigated its effects on asthma and nasal symptoms upon cat exposure, seasonal allergic rhinitis in asthma patients, and pharmacokinetics in young children with bronchiolitis.

Is MK-0476 the same as montelukast?

Yes, MK-0476 is the same as montelukast. The drug is referred to by both names in clinical research, with montelukast being the generic name and MK-0476 being the investigational code name used during development.