A Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-ocular Pressure
NCT ID: NCT01173471
Last Updated: 2014-02-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2010-12-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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1) AZD4017
Europe: 200 mg AZD4017
AZD4017
tablet, oral, one tablet once daily, 28 days
2) Placebo
Europe: placebo
Placebo
matching placebo tablet, oral, one tablet once daily, 28 days
3) AZD4017
USA: 800 mg AZD4017
AZD4017
tablet, oral 2 tablets twice daily, 28 days
4) Placebo
USA: placebo
Placebo
matching placebo tablets, oral, 2 tablets twice daily, 28 days
Interventions
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AZD4017
tablet, oral, one tablet once daily, 28 days
Placebo
matching placebo tablet, oral, one tablet once daily, 28 days
AZD4017
tablet, oral 2 tablets twice daily, 28 days
Placebo
matching placebo tablets, oral, 2 tablets twice daily, 28 days
Eligibility Criteria
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Inclusion Criteria
* Must have a diagnosis of intra-ocular hypertension (raised IOP), defined as an IOP ≥22 mmHg and ≤36 mmHg in the study eye while not on anti-glaucoma medication
* Male patients must be willing to use barrier contraception with spermicide, ie, condoms, from the day of first dosing until 3 months after dosing with IP
* Placebo treatment for duration of the study must not be considered detrimental to the patient
Exclusion Criteria
* Have experienced a significant visual field loss or showed evidence of progressive visual field loss within the last year (as defined by \>1 dB/yr average loss or vision threatening new defect)
* Have had severe eye trauma at any time
18 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Heather Bryson, PhD
Role: STUDY_DIRECTOR
AstraZeneca R&D
Tony Ho, MD
Role: STUDY_DIRECTOR
AstraZeneca R&D
Locations
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Research Site
Newport Beach, California, United States
Research Site
Atlanta, Georgia, United States
Research Site
Morrow, Georgia, United States
Research Site
Overland Park, Kansas, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Durham, North Carolina, United States
Research Site
Memphis, Tennessee, United States
Research Site
Lund, , Sweden
Research Site
Mölndal, , Sweden
Research Site
Stockholm, , Sweden
Research Site
Nottingham, , United Kingdom
Countries
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Other Identifiers
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2010-020932-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D4250C00001
Identifier Type: -
Identifier Source: org_study_id
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