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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: December 12, 2007
Last verified: December 2007
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Prevention of venous thromboembolism

Secondary Outcome Measures:
  • Assess safety and tolerability of DU-176b

Estimated Enrollment: 402
Study Start Date: January 2005
Study Completion Date: December 2005
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
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
Last Updated: December 12, 2007
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013