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Trial record 73 of 590 for:    WARFARIN

Interaction Between ABT-335, Rosuvastatin and Warfarin

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ClinicalTrials.gov Identifier: NCT00487136
Recruitment Status : Completed
First Posted : June 15, 2007
Last Update Posted : September 28, 2012
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
This is a multiple-dose, double-blind, randomized, single-center, parallel-group study in adult male subjects in general good health.

Condition or disease Intervention/treatment Phase
Healthy Drug: Warfarin Drug: warfarin plus ABT-335 plus rosuvastatin 5 mg Drug: warfarin plus ABT-335 plus rosuvastatin 20 mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Multiple-Dose Pharmacokinetic and Pharmacodynamic Interaction Between ABT-335, Rosuvastatin and Warfarin
Study Start Date : June 2007
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Drug: 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.
Other Name: Coumadin

Experimental: 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.
Drug: 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.
Other Names:
  • warfarin
  • coumadin ABT-335
  • fenofibric acid
  • Trilipix Rosuvastatin
  • Crestor

Experimental: 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.
Drug: 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 Names:
  • warfarin
  • coumadin
  • ABT-335
  • fenofibric acid
  • Trilipix Rosuvastatin
  • Crestor




Primary Outcome Measures :
  1. Pharmacokinetic parameters, pharmacodynamic variables [ Time Frame: Day 24 ]

Secondary Outcome Measures :
  1. Vital signs, physical examinations, laboratory tests, ECGs, adverse events [ Time Frame: Day 29 ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index (BMI) is 19 to 29, inclusive.
  • 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 with unstable medical conditions or medical conditions considered inappropriate in a clinical trial.
  • Subjects taking concomitant medications.
  • Subjects with a recent history of surgery or trauma.
  • Subjects with a history of any bleeding disorder.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487136


Locations
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United States, Arkansas
Site Ref # / Investigator 5290
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Torbjörn Lundström, MD AstraZeneca

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Responsible Party: Maureen Kelly, MD, Abbott
ClinicalTrials.gov Identifier: NCT00487136     History of Changes
Other Study ID Numbers: M06-887
First Posted: June 15, 2007    Key Record Dates
Last Update Posted: September 28, 2012
Last Verified: September 2012
Keywords provided by AstraZeneca:
Drug Interaction
Pharmacokinetics
Pharmacodynamics
Additional relevant MeSH terms:
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Warfarin
Rosuvastatin Calcium
Fenofibric acid
Fenofibrate
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anticoagulants