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
45 participants
INTERVENTIONAL
2007-06-30
2007-07-31
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
TREATMENT
DOUBLE
Study Groups
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Warfarin
Warfarin fixed dose plus one capsule containing placebo for ABT-335, one placebo tablet to match rosuvastatin 5 mg and one placebo tablet to match rosuvastatin 20 mg, administered for 10 consecutive days.
Warfarin
Warfarin fixed dose plus one capsule containing placebo for ABT-335, one placebo tablet to match rosuvastatin 5 mg and one placebo tablet to match rosuvastatin 20 mg, administered for 10 consecutive days.
Warfarin plus ABT-335 plus Rosuvastatin
Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one 5 mg tablet of rosuvastatin and one tablet of placebo to match rosuvastatin 20 mg, administered for 10 consecutive days.
warfarin plus ABT-335 plus rosuvastatin 5 mg
Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one 5 mg tablet of rosuvastatin and one tablet of placebo to match rosuvastatin 20 mg, administered for 10 consecutive days.
Warfarin plus ABT-335 mg plus rosuvastatin 20 mg
Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one tablet of placebo to match rosuvastatin 5 mg and one 20 mg tablet of rosuvastatin, administered for 10 consecutive days.
warfarin plus ABT-335 plus rosuvastatin 20 mg
Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one tablet of placebo to match rosuvastatin 5 mg and one 20 mg tablet of rosuvastatin, administered for 10 consecutive days.
Interventions
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Warfarin
Warfarin fixed dose plus one capsule containing placebo for ABT-335, one placebo tablet to match rosuvastatin 5 mg and one placebo tablet to match rosuvastatin 20 mg, administered for 10 consecutive days.
warfarin plus ABT-335 plus rosuvastatin 5 mg
Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one 5 mg tablet of rosuvastatin and one tablet of placebo to match rosuvastatin 20 mg, administered for 10 consecutive days.
warfarin plus ABT-335 plus rosuvastatin 20 mg
Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one tablet of placebo to match rosuvastatin 5 mg and one 20 mg tablet of rosuvastatin, administered for 10 consecutive days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
* Written informed consent prior to the initiation of screening or study-specific procedures.
Exclusion Criteria
* Subjects taking concomitant medications.
* Subjects with a recent history of surgery or trauma.
* Subjects with a history of any bleeding disorder.
18 Years
50 Years
MALE
Yes
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Abbott
Principal Investigators
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Torbjörn Lundström, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Site Ref # / Investigator 5290
Little Rock, Arkansas, United States
Countries
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Other Identifiers
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M06-887
Identifier Type: -
Identifier Source: org_study_id