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NCT Number: NCT00107900

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

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.

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Key information

Conditions

Arthroplasty, Replacement, Hip Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution

Decatur, Georgia, 30033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Du-176b

Drug

Primary outcomes

  1. Prevention of Venous Thromboembolism (VTE)

    Time frame: 2 weeks

    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 outcomes

  1. Change From Baseline for Prothrombin Time (PT) Results

    Time frame: end of treatment

    Intent to Treat (ITT) population

  2. Change From Baseline for International Normalized Ratio (INR) Results

    Time frame: end of treatment

    Intent to Treat (ITT) population

  3. Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results

    Time frame: end of treatment

    Intent to Treat (ITT) population

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Apr 12, 2005
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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