MK0476 Study in Adult Patients With Acute Asthma (0476-322)
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ClinicalTrials.gov Identifier: NCT00229970 |
Recruitment Status :
Completed
First Posted : September 30, 2005
Results First Posted : July 17, 2009
Last Update Posted : May 21, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: montelukast sodium Drug: Comparator: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 225 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | MK0476 Phase II/III Placebo Controlled Double Blind Study |
Study Start Date : | September 2005 |
Actual Primary Completion Date : | October 2006 |
Actual Study Completion Date : | June 2007 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
Placebo
|
Drug: Comparator: Placebo
Placebo single injection |
Experimental: 2
MK0476 7 mg injection
|
Drug: montelukast sodium
7 mg or 14 mg single injection |
Experimental: 3
MK0476 14 mg injection
|
Drug: montelukast sodium
7 mg or 14 mg single injection |
- The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1) [ Time Frame: baseline over the first 60 minutes ]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

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Ages Eligible for Study: | 15 Years to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult Patients With Acute Asthma Attacks
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00229970
Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00229970 History of Changes |
Other Study ID Numbers: |
0476-322 MK0476-322 2005_084 |
First Posted: | September 30, 2005 Key Record Dates |
Results First Posted: | July 17, 2009 |
Last Update Posted: | May 21, 2015 |
Last Verified: | May 2015 |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Montelukast |
Anti-Asthmatic Agents Respiratory System Agents Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP1A2 Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action |