Trial Outcomes & Findings for A Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty (NCT NCT01181167)
NCT ID: NCT01181167
Last Updated: 2019-03-05
Results Overview
The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment. * Lower extremity DVT confirmed by bilateral venography at the end of study treatment * Definite diagnosis of symptomatic PE * Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE
COMPLETED
PHASE3
610 participants
2 weeks
2019-03-05
Participant Flow
Participant milestones
| Measure |
DU-176b
DU-176b oral tablets, 30 mg., taken once daily for 2 weeks
edoxaban
|
Enoxaparin Sodium
enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks
enoxaparin sodium
|
|---|---|---|
|
Overall Study
STARTED
|
307
|
303
|
|
Overall Study
Efficacy Analysis Population
|
255
|
248
|
|
Overall Study
COMPLETED
|
284
|
271
|
|
Overall Study
NOT COMPLETED
|
23
|
32
|
Reasons for withdrawal
| Measure |
DU-176b
DU-176b oral tablets, 30 mg., taken once daily for 2 weeks
edoxaban
|
Enoxaparin Sodium
enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks
enoxaparin sodium
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
21
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
3
|
|
Overall Study
Protocol Violation
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
8
|
Baseline Characteristics
A Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
Baseline characteristics by cohort
| Measure |
DU-176b
n=255 Participants
DU-176b oral tablets, 30 mg., taken once daily for 2 weeks
edoxaban
|
Enoxaparin Sodium
n=248 Participants
enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks
enoxaparin sodium
|
Total
n=503 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 9.61 • n=5 Participants
|
62.8 years
STANDARD_DEVIATION 9.72 • n=7 Participants
|
62.8 years
STANDARD_DEVIATION 9.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
220 Participants
n=5 Participants
|
212 Participants
n=7 Participants
|
432 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
255 Participants
n=5 Participants
|
248 Participants
n=7 Participants
|
503 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
255 participants
n=5 Participants
|
248 participants
n=7 Participants
|
503 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: The FAS was defined as all subjects enrolled in the study, but excluded those who had significant GCP violations, who had not received any doses of the study drug, or those who did not develop symptomatic DVT or PE, but in whom venography was not appropriately performed.
The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment. * Lower extremity DVT confirmed by bilateral venography at the end of study treatment * Definite diagnosis of symptomatic PE * Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE
Outcome measures
| Measure |
DU-176b
n=255 Participants
DU-176b oral tablets, 30 mg., taken once daily for 2 weeks
edoxaban
|
Enoxaparin Sodium
n=248 Participants
enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks
enoxaparin sodium
|
|---|---|---|
|
Incidence of Subjects With Venous Thromboembolism Events
|
2.4 percentage of subjects with vte events
Interval 1.1 to 5.0
|
6.9 percentage of subjects with vte events
Interval 4.3 to 10.7
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Safety analyses were performed for the Safety Analysis Set, which was defined as all subjects who were secondarily enrolled in the study, but excluded those who had significant GCP violations, who had not received any doses of the study drug, or who had no safety data after the start of study treatment.
Outcome measures
| Measure |
DU-176b
n=303 Participants
DU-176b oral tablets, 30 mg., taken once daily for 2 weeks
edoxaban
|
Enoxaparin Sodium
n=301 Participants
enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks
enoxaparin sodium
|
|---|---|---|
|
Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding
|
2.6 percentage of subjects with bleeds
Interval 1.3 to 5.1
|
3.7 percentage of subjects with bleeds
Interval 2.1 to 6.7
|
Adverse Events
DU-176b
Enoxaparin Sodium
Serious adverse events
| Measure |
DU-176b
n=303 participants at risk
DU-176b oral tablets, 30 mg., taken once daily for 2 weeks
edoxaban
|
Enoxaparin Sodium
n=301 participants at risk
enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks
enoxaparin sodium
|
|---|---|---|
|
Vascular disorders
deep vein thrombosis
|
0.33%
1/303 • Number of events 1
|
0.33%
1/301 • Number of events 1
|
|
Injury, poisoning and procedural complications
femur fracture
|
0.66%
2/303 • Number of events 2
|
0.33%
1/301 • Number of events 1
|
|
Injury, poisoning and procedural complications
pelvic fracture
|
0.33%
1/303 • Number of events 1
|
0.00%
0/301
|
|
Infections and infestations
herpes zoster
|
0.33%
1/303 • Number of events 1
|
0.00%
0/301
|
|
Vascular disorders
otrhostatic hypotension
|
0.33%
1/303 • Number of events 1
|
0.00%
0/301
|
|
Injury, poisoning and procedural complications
Dislocation of joint prosthesis
|
0.66%
2/303 • Number of events 2
|
0.33%
1/301 • Number of events 1
|
|
Nervous system disorders
lacunar infarction
|
0.33%
1/303 • Number of events 1
|
0.00%
0/301
|
|
Gastrointestinal disorders
intestinal obstruction
|
0.00%
0/303
|
0.33%
1/301 • Number of events 1
|
|
Infections and infestations
postoperative wound infection
|
0.00%
0/303
|
0.33%
1/301 • Number of events 1
|
|
Injury, poisoning and procedural complications
hip fracture
|
0.00%
0/303
|
0.33%
1/301 • Number of events 1
|
|
Infections and infestations
abcess jaw
|
0.00%
0/303
|
0.33%
1/301 • Number of events 1
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/303
|
0.33%
1/301 • Number of events 1
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/303
|
0.33%
1/301 • Number of events 1
|
|
Gastrointestinal disorders
gastroenteritis
|
0.00%
0/303
|
0.33%
1/301 • Number of events 1
|
Other adverse events
| Measure |
DU-176b
n=303 participants at risk
DU-176b oral tablets, 30 mg., taken once daily for 2 weeks
edoxaban
|
Enoxaparin Sodium
n=301 participants at risk
enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks
enoxaparin sodium
|
|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
17/303 • Number of events 17
|
32.2%
97/301 • Number of events 98
|
|
Investigations
Gamma-glutamyltransferase increased
|
14.5%
44/303 • Number of events 45
|
26.2%
79/301 • Number of events 81
|
|
Investigations
Alanine aminotransferase increased
|
11.9%
36/303 • Number of events 37
|
41.9%
126/301 • Number of events 128
|
|
Investigations
Blood urine present
|
12.5%
38/303 • Number of events 39
|
11.3%
34/301 • Number of events 37
|
|
Investigations
Blood alkaline phosphatase increased
|
4.6%
14/303 • Number of events 15
|
13.3%
40/301 • Number of events 41
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
4.0%
12/303 • Number of events 12
|
7.0%
21/301 • Number of events 23
|
|
Investigations
Blood bilirubin increased
|
3.6%
11/303 • Number of events 11
|
3.3%
10/301 • Number of events 10
|
|
Nervous system disorders
headache
|
3.6%
11/303 • Number of events 12
|
4.0%
12/301 • Number of events 12
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.0%
9/303 • Number of events 10
|
1.7%
5/301 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
10/303 • Number of events 10
|
3.3%
10/301 • Number of events 10
|
|
Renal and urinary disorders
Haematuria
|
3.6%
11/303 • Number of events 12
|
0.66%
2/301 • Number of events 2
|
Additional Information
Masayuki Fukuzawa, Associate Director
Daiichi Sankyo Co., Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee PI shall not publish the results of the Study at any time without the prior written approval of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER