Status:
TERMINATED
Study 08-114 Open-label Extension of Study 08-110 - A Multi-Center Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease (P08642)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
5+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to obtain data on the potential of long-term treatment with denufosol to improve the clinical course of CF lung disease in patients with mildly impaired lung function and ...
Eligibility Criteria
Inclusion
- Completed Study 08-110
Exclusion
- A female patient will not be eligible for the study if she is of childbearing potential and is pregnant, lactating, and/or not practicing an acceptable method of birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization, or intrauterine device).
- Have a condition that might affect compliance with study procedures
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT00846781
Start Date
February 1 2009
End Date
February 1 2011
Last Update
November 6 2015
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