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Drug-Drug Interaction Study to Assess the Effects of Steady State Pitavastatin 4 mg or Rosuvastatin 40 mg on Steady-State Warfarin in Healthy Adult Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01178853
First Posted: August 10, 2010
Last Update Posted: October 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kowa Research Institute, Inc.
  Purpose
This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug interaction study.

Condition Intervention Phase
Healthy Drug: Warfarin Drug: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD) Drug: Warfarin 5 mg + Pitavastatin 4mg once daily (QD) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Drug-Drug Interaction Study to Assess the Effects of Steady State Pitavastatin 4 mg or Rosuvastatin 40 mg on Steady-State Warfarin in Healthy Adult Volunteers

Resource links provided by NLM:


Further study details as provided by Kowa Research Institute, Inc.:

Primary Outcome Measures:
  • Percent Mean Change From Baseline of International Normalized Ratio (INR) [ Time Frame: 22 Days ]
    INR is the ratio of a patient's prothrombin time to a standard, raised to the power of the ISI value for the tissue factor reagent used (INR = (PT-Test/PT-Normal)^ISI)


Enrollment: 48
Study Start Date: July 2010
Study Completion Date: April 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pitavastatin/Rosuvastatin Drug: Warfarin
Warfarin 5 mg once daily
Drug: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)
Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)
Drug: Warfarin 5 mg + Pitavastatin 4mg once daily (QD)
Warfarin 5 mg + Pitavastatin 4mg
Experimental: Rosuvastatin/Pitavastatin Drug: Warfarin
Warfarin 5 mg once daily
Drug: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)
Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)
Drug: Warfarin 5 mg + Pitavastatin 4mg once daily (QD)
Warfarin 5 mg + Pitavastatin 4mg

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is a healthy adult male or female volunteer aged 18 to 45 years, inclusive
  • Subject has a body mass index of 18 to 32 kg/m2, inclusive
  • Subject is able and willing to abstain from alcohol, grapefruit, caffeine
  • Subject has no clinically relevant abnormalities on the basis of medical history, physical examination, and vital signs

Exclusion Criteria:

  • Subject has clinically relevant out-of-range prothrombin time (PT), activated partial thromboplastin time, fibrinogen, protein C, or protein S
  • Subject has abnormal prolongation of bleeding time at Screening
  • Subject has hematuria on urinalysis
  • Subject has personal or family history of coagulation or bleeding disorders
  Contacts and Locations
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): NCT01178853


Locations
United States, Texas
Austin, Texas, United States
Sponsors and Collaborators
Kowa Research Institute, Inc.
  More Information

Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01178853     History of Changes
Other Study ID Numbers: NK-104-4.03US
First Submitted: August 9, 2010
First Posted: August 10, 2010
Results First Submitted: March 29, 2012
Results First Posted: October 8, 2012
Last Update Posted: October 8, 2012
Last Verified: September 2012

Keywords provided by Kowa Research Institute, Inc.:
Healthy Volunteers

Additional relevant MeSH terms:
Rosuvastatin Calcium
Pitavastatin
Warfarin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anticoagulants