MK0476 Study in Adult Patients With Acute Asthma (0476-322)
MK0476 Phase II/III Placebo Controlled Double Blind Study
3 other identifiers
interventional
225
0 countries
N/A
Brief Summary
This study evaluates the efficacy and safety of MK0476 intravenous administration in adult patients with acute asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 asthma
Started Sep 2005
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 28, 2005
CompletedFirst Posted
Study publicly available on registry
September 30, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedResults Posted
Study results publicly available
July 17, 2009
CompletedFebruary 2, 2022
January 1, 2022
1.1 years
September 28, 2005
May 22, 2009
January 31, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1)
The Time Weighed Average Changes in Forced Expiratory Volume in One Second (FEV1) from pre-allocation baseline over the first 60 minutes after study drug administration with time interval between any measurement and the measurement prior to it is used as the weighting factor
baseline over the first 60 minutes
Study Arms (3)
1
EXPERIMENTALPlacebo
2
EXPERIMENTALMK0476 7 mg injection
3
EXPERIMENTALMK0476 14 mg injection
Interventions
Eligibility Criteria
You may qualify if:
- Adult Patients With Acute Asthma Attacks
You may not qualify if:
- Patient Has Any Known Or Suspected, Acute Or Chronic Cause For Their Pulmonary Symptoms Other Than Asthma (E.G., Copd, Chronic Heart Failure, Etc.)
- Patient Has A Smoking History (20 Cigarettes Per Day) Of More Than 15 Years
- Patient Has A Disease Of The Cardiovascular, Hepatic, Renal, Hematologic Systems, Or Other Severe Disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related Publications (1)
Adachi M, Taniguchi H, Tohda Y, Sano Y, Ishine T, Smugar SS, Hisada S. The efficacy and tolerability of intravenous montelukast in acute asthma exacerbations in Japanese patients. J Asthma. 2012 Aug;49(6):649-56. doi: 10.3109/02770903.2012.690479. Epub 2012 Jun 28.
PMID: 22742205DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2005
First Posted
September 30, 2005
Study Start
September 1, 2005
Primary Completion
October 1, 2006
Study Completion
June 1, 2007
Last Updated
February 2, 2022
Results First Posted
July 17, 2009
Record last verified: 2022-01