Status:
COMPLETED
A Study in Pediatric Patients With Cystic Fibrosis Lung Disease
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
5-7 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate the safety and effectiveness of two dose strengths of study drug compared to placebo in pediatric patients with cystic fibrosis (CF).
Eligibility Criteria
Inclusion
- Have confirmed diagnosis of CF
- Have an FEV1 greater than or equal to 60%
- Have oxygen saturation greater than or equal to 90% on room air
- Be clinically stable for at least 4 weeks prior to screening
- Be able to reproducibly perform spirometry maneuvers
Exclusion
- Have clinically significant comorbidities
- Have changed their physiotherapy technique or schedule within 7 days prior to screening
- Using prior and concurrent medications according to protocol
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00130182
Start Date
August 1 2005
Last Update
May 22 2013
Active Locations (3)
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1
The Children's Hospital
Denver, Colorado, United States, 80218
2
General Clinic Research Center University of Minnesota
Minneapolis, Minnesota, United States, 55455
3
The Minnesota CF Center
Minneapolis, Minnesota, United States, 55455