A Dose Finding Study of AEB071 Assessing Psoriasis Area and Severity Index in Patients With Plaque Psoriasis
NCT ID: NCT00885196
Last Updated: 2020-12-22
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
PHASE2
336 participants
INTERVENTIONAL
2009-04-30
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
TREATMENT
DOUBLE
Study Groups
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AEB071 200 mg BID
AEB071
AEB071 400 mg OD
AEB071
AEB071 300 mg BID
AEB071
Placebo BID
Placebo
Interventions
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Placebo
AEB071
Eligibility Criteria
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Inclusion Criteria
* Severity of disease meeting all of the following three criteria:
* PASI score of 10 or greater
* Total Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater
* Investigator's Global Assessment (IGA) score of 3 or greater
Exclusion Criteria
* Heart rate \< 50 or \> 90 bpm when resting for 5 minutes
* Family history of long QT syndrome
* History of tachyarrhythmia
* History of conduction abnormality i.e., PR \> 200 msec, 2nd or 3rd degree AV block, complete left or right branch bundle block, pre-excitation syndrome
* Uncontrolled or unstable angina pectoris; history of myocardial infarction within the previous 12 months
* Known history of congestive heart failure
* History of percutaneous coronary intervention (PCI) or cardiac ablation
* History of stroke or transient ischemic attack (TIA)
* Implanted cardiac pacemaker or defibrillator
* History of malignancy of any organ system
* Current guttate, generalized erythrodermic, or pustular psoriasis
* Current drug associated psoriasis
18 Years
75 Years
ALL
No
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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Burke Pharmaceutical Research
Hot Springs, Arizona, United States
Belleair Research Center, LLC
Pinellas Park, Florida, United States
Kansas City Dermatology, PA
Overland Park, Kansas, United States
Dermatology Specialists
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Central Dermatology
St Louis, Missouri, United States
Palmetto Clinical Trial Services
Greenville, South Carolina, United States
Center for Clinical Studies
Houston, Texas, United States
Suzanne Bruce & Associates, PA
Houston, Texas, United States
Virginia Clinical Research
Norfolk, Virginia, United States
Novartis Investigative site
Buenos Aires, , Argentina
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Mendoza, , Argentina
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Benowa, , Australia
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Carlton, , Australia
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Kogarah, , Australia
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Parkville, , Australia
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Brussels, , Belgium
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Edegem, , Belgium
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Liège, , Belgium
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Berlin, , Germany
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Bonn, , Germany
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Erlangen, , Germany
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Frankfurt, , Germany
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Hamburg, , Germany
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Kiel, , Germany
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Leipzig, , Germany
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Regensburg, , Germany
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Guatemala City, , Guatemala
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Milan, , Italy
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Modena, , Italy
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Rome, , Italy
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Siena, , Italy
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Verona, , Italy
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Ankara, , Turkey (Türkiye)
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Gaziantep, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Manisa, , Turkey (Türkiye)
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Nuneaton, , United Kingdom
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Salford, , United Kingdom
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Southampton, , United Kingdom
Countries
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Related Links
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Results for CAEB071C2201 from the Novartis Clinical Trials Results Website
Other Identifiers
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EUDRACT number: 2007-007160-19
Identifier Type: -
Identifier Source: secondary_id
CAEB071C2201
Identifier Type: -
Identifier Source: org_study_id