HealthyPhase 4NCT01178853
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
A Phase 4 study testing Warfarin, Warfarin 5mg + Rosuvastatin 40 mg once daily (QD) and Warfarin 5 mg + Pitavastatin 4mg once daily (QD) in people with Healthy, run by Kowa Research Institute, Inc. at 1 site in United States.
Trial summary
This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug interaction study. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Warfarin, Warfarin 5mg + Rosuvastatin 40 mg once daily (QD) and Warfarin 5 mg + Pitavastatin 4mg once daily (QD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Apr 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug interaction study.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarfarinDrug
Warfarin 5 mg once daily
Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)Drug
Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)
Warfarin 5 mg + Pitavastatin 4mg once daily (QD)Drug
Warfarin 5 mg + Pitavastatin 4mg
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin/Rosuvastatin | Experimental | Not described Receives: Drug: Warfarin; Drug: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD); Drug: Warfarin 5 mg + Pitavastatin 4mg once daily (QD) |
| Rosuvastatin/Pitavastatin | Experimental | Not described Receives: Drug: Warfarin; Drug: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD); Drug: Warfarin 5 mg + Pitavastatin 4mg once daily (QD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Mean Change From Baseline of International Normalized Ratio (INR)
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)
Measured: 22 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowa Research Institute, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178853
- Sponsor's protocol ID
- NK-104-4.03US
- Status last verified
- Sep 2012
- First submitted
- 9 Aug 2010
- Last updated
- 8 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01178853
- Acronym / sponsor ID
- NK-104-4.03US
- Conditions
- Healthy
- Keywords
- Healthy Volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 10 Aug 2010 (estimated)
- Results
- Posted 8 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug interaction study.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pitavastatin/Rosuvastatin | Experimental | Drug: Warfarin, Drug: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD), Drug: Warfarin 5 mg + Pitavastatin 4mg once daily (QD) |
| Rosuvastatin/Pitavastatin | Experimental | Drug: Warfarin, Drug: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD), Drug: Warfarin 5 mg + Pitavastatin 4mg once daily (QD) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WarfarinWarfarin 5 mg once daily | Drug | Pitavastatin/Rosuvastatin, Rosuvastatin/Pitavastatin |
| Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)Warfarin 5mg + Rosuvastatin 40 mg once daily (QD) | Drug | Pitavastatin/Rosuvastatin, Rosuvastatin/Pitavastatin |
| Warfarin 5 mg + Pitavastatin 4mg once daily (QD)Warfarin 5 mg + Pitavastatin 4mg | Drug | Pitavastatin/Rosuvastatin, Rosuvastatin/Pitavastatin |
Primary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Warfarin, Warfarin 5mg + Rosuvastatin 40 mg once daily (QD) and Warfarin 5 mg + Pitavastatin 4mg once daily (QD) in people with Healthy, run by Kowa Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Mean Change From Baseline of International Normalized Ratio (INR) (time frame: 22 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2012.