A Study of DU-176b in Preventing Blood Clots After Hip Replacement Surgery
This study has been completed.
Sponsor:
Daiichi Sankyo Inc.
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00398216
First received: November 9, 2006
Last updated: September 27, 2010
Last verified: September 2010
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Purpose
This study is to assess if DU176b is effective in prevention of blood clots following hip replacement surgery. The duration is 7-10 days of treatment and 30 and 60 day follow-up visits.
| Condition | Intervention | Phase |
|---|---|---|
|
Thrombosis Hip Replacement |
Drug: DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | A Phase IIb, Randomized, Parallel Group, Double-Blind, Double-Dummy, Multi-Center, Multi-National, Multi-Dose, Study of DU-176b Compared to Dalteparin in Patients Undergoing Elective Unilateral Total Hip Replacement |
Resource links provided by NLM:
Further study details as provided by Daiichi Sankyo Inc.:
Primary Outcome Measures:
- Assess the efficacy of DU-176b in the prevention of venous thromboembolism (VTE) from 6 to 8 hours after hip replacement surgery to 7 to 10 days after the surgery. [ Time Frame: 6 to8 hours after after hip replacement surgery to 7 to 10 days after the surgery. ] [ Designated as safety issue: No ]
A subject was judged to have a VTE if one or more of the following criteria were met:
- Observed lower extremity deep vein thrombosis (DVT) (either proximal, distal, or both ) as assessed by bilateral or unilateral ascending contrast venography prior to or at the end-of-treatment (EOT) visit
- Symptomatic and objectively proven pulmonary embolism prior to or at the EOT visit
- Symptomatic and objectively proven DVT prior to or at EOT visit
Secondary Outcome Measures:
- The incidence of major venous thromboembolism (including proximal deep vein thrombosis and symptomatic pulmonary embolism) plus all cause mortality from 6 to 8 hours after hip replacement surgery to 7-10 days after the surgery [ Time Frame: 6-8 hours after hip replacement surgery to 7 to 10 days after the surgery ] [ Designated as safety issue: No ]
| Enrollment: | 903 |
| Study Start Date: | May 2006 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
- 18 years of age or older; male or female.
- Able to provide written informed consent.
- Must be scheduled for elective unilateral total hip replacement surgery. Only primary surgeries accepted.
- If female, must be either one year post-menopausal, surgically sterile, or using medically accepted contraceptive measures as judged by the Investigator and in accordance with local regulatory requirements.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398216
Locations
| United States, Connecticut | |
| Hartford, Connecticut, United States | |
| United States, Florida | |
| Sarasota, Florida, United States | |
| United States, Texas | |
| Austin, Texas, United States | |
| Canada, Ontario | |
| Ajax, Ontario, Canada | |
| Cambridge, Ontario, Canada | |
| Guelph, Ontario, Canada | |
| Kitchner, Ontario, Canada | |
| Toronto, Ontario, Canada | |
| Denmark | |
| Hellerup, Denmark | |
| Herlev, Denmark | |
| Horsholm, Denmark | |
| Hungary | |
| Gyula, Hungary | |
| Kecskemet, Hungary | |
| Szeged, Hungary | |
| Latvia | |
| Riga, Latvia | |
| Russian Federation | |
| Krasnoyarsk, Russian Federation | |
| Moscow, Russian Federation | |
| Saratov, Russian Federation | |
| St. Petersburg, Russian Federation | |
| Velikij Novgorod, Russian Federation | |
| Volgograd, Russian Federation | |
| Ukraine | |
| Chernivtsy, Ukraine | |
| Dnepropetrovsk, Ukraine | |
| Donetsk, Ukraine | |
| Kharkiv, Ukraine | |
| Kharkov, Ukraine | |
| Kiev, Ukraine | |
| Lutsk, Ukraine | |
| Lviv, Ukraine | |
| Odessa, Ukraine | |
Sponsors and Collaborators
Daiichi Sankyo Inc.
More Information
No publications provided
| Responsible Party: | Anne MacDonald, Daiichi Sankyo |
| ClinicalTrials.gov Identifier: | NCT00398216 History of Changes |
| Other Study ID Numbers: | DU176b-PRT011, 2006-000758-29 |
| Study First Received: | November 9, 2006 |
| Last Updated: | September 27, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Daiichi Sankyo Inc.:
|
Anti-coagulant hip replacement hip replacement surgery unilateral hip replacement surgery |
DeepVein Thrombosis Venous Thromboembolism pulmonary embolism Prevention of Blood Clots |
Additional relevant MeSH terms:
|
Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013