Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
33 participants
INTERVENTIONAL
2013-03-31
2015-03-31
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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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LDE225
LDE225
LDE225
LDE225
Interventions
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LDE225
LDE225
Eligibility Criteria
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Inclusion Criteria
* Normal Vital signs
Inclusion (group mild, moderate and severe hepatic impairment):
-Subjects with confirmed cirrhosis
Exclusion (all groups):
* Woman of childbearing potential and pregnant or lactating females or male not using condom
* Risk factors for torsades de pointes
* Clinically significant cardio-vascular disease
* severe or uncontrolled medical conditions
* Smokers consuming greater than 10 cigarettes or equivalent nicotine containing products per day.
* Use of investigational drugs (i.e. participation in any clinical investigation)
Exclusion for moderate, mild and severe groups:
* Symptoms or history of encephalopathy
* Clinical evidence of severe ascites
Exclusion Criteria
18 Years
65 Years
ALL
Yes
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of Miami Div. of Clinical Pharmacology
Miami, Florida, United States
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Sofia, , Bulgaria
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Tel Aviv, , Israel
Countries
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Related Links
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Results for CLDE225A2113 from Novartis Clinical Trials website
Other Identifiers
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CLDE225A2113
Identifier Type: -
Identifier Source: org_study_id