A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Cystic Fibrosis
NCT ID: NCT00757848
Last Updated: 2012-08-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
56 participants
INTERVENTIONAL
2008-10-31
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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AZD9668
AZD9668
60 mg, oral tablet, twice daily for 28 days
Placebo
AZD9668 Placebo equivalent
Match placebo to 60 mg, oral tablet, twice daily for 28 days
Interventions
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AZD9668
60 mg, oral tablet, twice daily for 28 days
AZD9668 Placebo equivalent
Match placebo to 60 mg, oral tablet, twice daily for 28 days
Eligibility Criteria
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Inclusion Criteria
* Have a clinical diagnosis of Cystic Fibrosis with lung function tests greater or equal to 40% of normal
* Have normal renal function
Exclusion Criteria
* Significant liver disease
* Any other non-CF-related lung disease that may interfere with study assessments
16 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Prof. Elborn
Role: PRINCIPAL_INVESTIGATOR
Belfast hospital
Joanna Marks-Konczalik
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Copenhagen, , Denmark
Research Site
Hamburg, , Germany
Research Site
Kiel, , Germany
Research Site
Leipzig, , Germany
Research Site
München, , Germany
Research Site
Rabka-Zdrój, , Poland
Research Site
Warsaw, , Poland
Research Site
Moscow, , Russia
Research Site
Gothenburg, , Sweden
Research Site
Lund, , Sweden
Research Site
Stockholm, , Sweden
Research Site
Uppsala, , Sweden
Research Site
Belfast, Northern Ireland, United Kingdom
Research Site
Liverpool, , United Kingdom
Countries
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References
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Elborn JS, Perrett J, Forsman-Semb K, Marks-Konczalik J, Gunawardena K, Entwistle N. Efficacy, safety and effect on biomarkers of AZD9668 in cystic fibrosis. Eur Respir J. 2012 Oct;40(4):969-76. doi: 10.1183/09031936.00194611. Epub 2012 Jan 20.
Other Identifiers
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D0520C00009
Identifier Type: -
Identifier Source: org_study_id