Trial Outcomes & Findings for 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 (NCT NCT01178853)
NCT ID: NCT01178853
Last Updated: 2012-10-08
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
48 participants
Primary outcome timeframe
22 Days
Results posted on
2012-10-08
Participant Flow
14 July 2010 - 09 November 2010
Participant milestones
| Measure |
Pitavastatin/Rosuvastatin
|
Rosuvastatin/Pitavastatin
|
|---|---|---|
|
Period 1 (Warfarin Titration)
STARTED
|
24
|
24
|
|
Period 1 (Warfarin Titration)
COMPLETED
|
23
|
22
|
|
Period 1 (Warfarin Titration)
NOT COMPLETED
|
1
|
2
|
|
Period 2 (Warfarin + Study Drug)
STARTED
|
23
|
22
|
|
Period 2 (Warfarin + Study Drug)
COMPLETED
|
22
|
22
|
|
Period 2 (Warfarin + Study Drug)
NOT COMPLETED
|
1
|
0
|
|
Period 3 (Warfarin Titration)
STARTED
|
22
|
22
|
|
Period 3 (Warfarin Titration)
COMPLETED
|
21
|
22
|
|
Period 3 (Warfarin Titration)
NOT COMPLETED
|
1
|
0
|
|
Period 4 (Warfarin + Study Drug)
STARTED
|
21
|
22
|
|
Period 4 (Warfarin + Study Drug)
COMPLETED
|
21
|
19
|
|
Period 4 (Warfarin + Study Drug)
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Pitavastatin/Rosuvastatin
|
Rosuvastatin/Pitavastatin
|
|---|---|---|
|
Period 1 (Warfarin Titration)
INR Out of Range
|
1
|
2
|
|
Period 2 (Warfarin + Study Drug)
Withdrawal by Subject
|
1
|
0
|
|
Period 3 (Warfarin Titration)
Adverse Event
|
1
|
0
|
|
Period 4 (Warfarin + Study Drug)
Adverse Event
|
0
|
2
|
|
Period 4 (Warfarin + Study Drug)
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Pitavastatin/Rosuvastatin
n=24 Participants
|
Rosuvastatin/Pitavastatin
n=24 Participants
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
32.4 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
34.1 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
33.3 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 22 DaysINR 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)
Outcome measures
| Measure |
Warfarin + Pitavastatin
n=42 Participants
|
Warfarin + Rosuvastatin
n=43 Participants
|
|---|---|---|
|
Percent Mean Change From Baseline of International Normalized Ratio (INR)
|
0.0452 percent change
Standard Deviation 2.61
|
0.1605 percent change
Standard Deviation 9.43
|
Adverse Events
Warfarin + Pitavastatin
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Warfarin + Rosuvastatin
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Warfarin + Pitavastatin
n=42 participants at risk
|
Warfarin + Rosuvastatin
n=43 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.1%
3/42
|
7.0%
3/43
|
|
Nervous system disorders
Headache
|
7.1%
3/42
|
0.00%
0/43
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee May not publish
- Publication restrictions are in place
Restriction type: OTHER