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Sponsored by: |
MAP Pharmaceuticals, Inc. |
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Information provided by: | MAP Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00569192 |
The purpose of this study is to examine the safety and efficacy of two doses of MAP0010 versus placebo in asthmatic infants and children, 12 months to 8 years of age, over a 12-week treatment period.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: MAP0010 Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double Blind, Placebo Controlled, Parallel Group, Study Investigating the Safety and Efficacy Over 12 Weeks Treatment Period of MAP0010 in Asthmatic Infants and Children 12 Months to 8 Years of Age |
Estimated Enrollment: | 360 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
MAP0010 low dose
|
Drug: MAP0010
low dose; inhalation; twice daily
|
2: Active Comparator
MAP0010 high dose
|
Drug: MAP0010
high dose; inhalation; twice daily
|
3: Placebo Comparator |
Drug: Placebo
Inhalation; twice daily
|
Ages Eligible for Study: | 12 Months to 8 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Chris Allen | 650-861-7032 | callen@mappharma.com |
United States, California | |
Recruiting | |
San Diego, California, United States |
Study Director: | Shahid Siddiqui, MD | MAP Pharmaceuticals |
Responsible Party: | MAP Pharmaceuticals ( Dr Shahid Siddiqui/Director of Clinical Development ) |
Study ID Numbers: | MAP0010-CL-P301 |
Study First Received: | December 5, 2007 |
Last Updated: | May 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00569192 |
Health Authority: | United States: Food and Drug Administration |
asthmatic infants and children |
Asthma |