A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
This study has been completed.
Sponsor:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01203098
First received: September 14, 2010
Last updated: February 6, 2015
Last verified: February 2015
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Purpose
The objective of this study is to compare the efficacy, safety of DU-176b 30mg or DU-176b 15mg versus enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.
| Condition | Intervention | Phase |
|---|---|---|
|
Venous Thromboembolism Thromboembolism Thrombosis Embolism and Thrombosis Deep Vein Thrombosis Arthroplasty, Replacement, Hip |
Drug: DU-176b 15mg Drug: DU-176b 30mg Drug: Enoxaparin sodium 20 mg (=2000IU) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Phase 2b, Randomized, Multi-Dose Efficacy,Safety Study of the Oral Factor Xa Inhibitor DU-176b Versus Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty (STARS J-2) |
Resource links provided by NLM:
Further study details as provided by Daiichi Sankyo Inc.:
Primary Outcome Measures:
- Percentage of Subjects With Venous Thromboembolism Events [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
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
Secondary Outcome Measures:
- Incidence of Major Bleeding or Clinically Relevant Non-major Bleedings. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 264 |
| Study Start Date: | July 2008 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: DU-176b 30mg once daily
DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery
|
Drug: DU-176b 30mg
DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery.
Other Name: edoxaban
|
|
Active Comparator: Enoxaparin sodium twice daily
Enoxaparin sodium 20mg (=2000IU) / 0.2mL twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery
|
Drug: Enoxaparin sodium 20 mg (=2000IU)
Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks initiated within 24 to 36 hours after surgery.
|
|
Experimental: DU-176b 15mg once daily
DU-176b 15mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery
|
Drug: DU-176b 15mg
DU-176b 15 mg tablets oral, once daily for 2 weeks initiated within 6 to 24 hours after surgery.
Other Name: edoxaban
|
Eligibility| Ages Eligible for Study: | 20 Years to 84 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients undergoing unilateral total hip arthroplasty
- Patients who are 20-84 years olds
Exclusion Criteria:
- Subjects with risks of hemorrhage
- Subjects with thromboembolic risks
- Subjects who weigh less than 40 kg
- Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01203098
Please refer to this study by its ClinicalTrials.gov identifier: NCT01203098
Locations
| Japan | |
| Osaka, Japan | |
| Tokyo, Japan | |
| Taiwan | |
| Kaohsiung, Taiwan | |
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
| Principal Investigator: | Takeshi Fuji | Osaka Koseinenkin Hospital |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Daiichi Sankyo Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01203098 History of Changes |
| Other Study ID Numbers: | DU176b-B-J209 |
| Study First Received: | September 14, 2010 |
| Results First Received: | January 15, 2015 |
| Last Updated: | February 6, 2015 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Daiichi Sankyo Inc.:
|
prevention venous thromboembolism edoxaban anticoagulants |
Additional relevant MeSH terms:
|
Thrombosis Thromboembolism Embolism Venous Thromboembolism Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Edoxaban Factor Xa Inhibitors |
Enoxaparin Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents |
ClinicalTrials.gov processed this record on September 27, 2016