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Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00107900
First received: April 11, 2005
Last updated: February 26, 2015
Last verified: February 2015
  Purpose

Patients who undergo total hip replacement surgery are at greater risk of getting deep vein thrombosis (blood clots). This study evaluates the safety, tolerability and effectiveness of the study drug, DU-176b, in reducing the occurrence of deep vein thrombosis in patients having total hip replacement surgery.


Condition Intervention Phase
Arthroplasty, Replacement, Hip
Thrombosis
Drug: DU-176b
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase IIa, Multi-center, Multi-national, Open Label, Dose Ranging Study of the Efficacy, Safety, and Tolerability of Oral DU-176b Administered Once or Twice Daily in the Treatment of Adult Patients Undergoing Total Hip Arthroplasty

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Prevention of Venous Thromboembolism (VTE) [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

    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 (approximately 2 weeks post surgery).

    Confirmed deep vein thrombosis ( both proximal and distal ) as assessed by unilateral or bilateral ascending contrast venograms 7 to 10 days following surgery Symptomatic and objectively proven Pulmonary Embolism (PE) prior to venography Symptomatic and objectively proven Deep Vein Thrombosis (DVT) prior to venography



Secondary Outcome Measures:
  • Change From Baseline for Prothrombin Time (PT) Results [ Time Frame: end of treatment ] [ Designated as safety issue: Yes ]
    Intent to Treat (ITT) population

  • Change From Baseline for International Normalized Ratio (INR) Results [ Time Frame: end of treatment ] [ Designated as safety issue: Yes ]
    Intent to Treat (ITT) population

  • Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results [ Time Frame: end of treatment ] [ Designated as safety issue: Yes ]
    Intent to Treat (ITT) population


Enrollment: 606
Study Start Date: January 2005
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 15mg BID
15mg edoxaban administered twice daily (BID)
Drug: DU-176b
Experimental: 30mg QD
30mg edoxaban administered once daily (QD)
Drug: DU-176b
Experimental: 30mg BID
30mg edoxaban administered twice daily (BID)
Drug: DU-176b
Experimental: 60mg QD
60mg edoxaban administered once daily (QD)
Drug: DU-176b
Experimental: 60mg BID
60mg edoxaban administered twice daily (BID)
Drug: DU-176b
Experimental: 120mg QD
120mg edoxaban administered once daily (QD)
Drug: DU-176b

Detailed Description:

The primary study objective is to demonstrate prevention of venous thromboembolism in patients undergoing total hip replacement surgery. The secondary objective is to assess the safety and tolerability of DU-176.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral hip replacement

Exclusion Criteria:

  • Patients scheduled for bilateral hip replacement in same procedure
  • Patients with increased risk of bleeding
  • Uncontrolled hypertension (BP greater than 180/100 mmHg)
  • Patients less than 111 lbs or more than 243 lbs
  • Patients on long-term anticoagulants
  • Patients with contraindications to venography
  • Patients with medical history of venous thromboembolism
  • Patients with impaired hepatic function
  • Known to be pregnant
  • Lactating women
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107900

Locations
United States, Georgia
Local Institution
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided

Responsible Party: Anne MacDonald, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00107900     History of Changes
Other Study ID Numbers: DU176b-PRT007
Study First Received: April 11, 2005
Results First Received: February 5, 2015
Last Updated: February 26, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
Deep Vein Thrombosis,
Anticoagulant,
Venous thromboembolic

ClinicalTrials.gov processed this record on March 03, 2015