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aminophylline hydrate

Phase 3

Asthma | Small molecule | Respiratory |Organon & Co.|Last Updated: Feb 2, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment91

FDA Designations

No designations recorded

Clinical trial landscape

aminophylline hydrate · 1 trial · 1 indication

Phase 3 1
NCT00442338Study of MK-0476 in Adult Patients With Acute Asthma (0476-334)Asthma
COMPLETED91 Analytics
PHASE3COMPLETED
Study of MK-0476 in Adult Patients With Acute Asthma (0476-334)
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration
Baseline and 60 minutes after study drug administration

The time weighted average change from Baseline in Forced Expiratory Volume in One Second (FEV1) over the first 60 minutes after study drug administration (average change FEV1 (0-60 min)). Baseline (pre-allocation) was the last measurement obtained during the screening period.

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Montelukast 7 mgEXPERIMENTALMontelukast 7 mg IV administration
Montelukast 14 mgEXPERIMENTALMontelukast 14 mg IV administration
Aminophylline 250 mgACTIVE_COMPARATORAminophylline 250 mg IV drip administration

Interventions

NameTypeDescription
montelukast sodiumDRUGMontelukast 7 mg single injection (IV bolus administration) over 2-3 minutes
aminophylline hydrateDRUGAminophylline 250 mg IV drip infusion over 60 minutes
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Eligibility Criteria

Age Range15 Years to 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Adult participants with acute asthma attacks Exclusion Criteria: * Participant has any known or suspected, acute or chronic cause for their pulmonary symptoms other than asthma (e.g., COPD, chronic heart failure, etc.). * Participant has a smoking habit (15 cigarettes per da...

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Frequently asked questions about aminophylline hydrate

What is aminophylline hydrate used for?

Aminophylline hydrate is used for asthma. It is a small molecule being studied as a treatment for asthma in adult patients. The drug is currently in Phase 3 clinical development and is being developed by Organon & Co. (NYSE: OGN).

Who makes aminophylline hydrate?

Aminophylline hydrate is being developed by Organon & Co., a pharmaceutical company traded on the New York Stock Exchange under the ticker OGN. The drug is in Phase 3 clinical development for the treatment of asthma.

What phase is aminophylline hydrate in?

Aminophylline hydrate is in Phase 3 clinical development. It is an investigational drug being studied for the treatment of asthma. The drug has completed one Phase 3 clinical trial and is not yet approved by regulatory authorities.

What clinical trials is aminophylline hydrate in?

Aminophylline hydrate has been studied in one completed Phase 3 clinical trial, identified as NCT00442338. This trial, titled "Study of MK-0476 in Adult Patients With Acute Asthma (0476-334)," enrolled 91 participants aged 15 years and older with asthma. The trial was active-controlled and randomized.

Is aminophylline hydrate the same as MK-0476?

Aminophylline hydrate is associated with the clinical trial identifier NCT00442338, which references MK-0476 in its title. The trial studied the drug in adult patients with acute asthma, and the compound is being developed by Organon & Co. for the treatment of asthma.