Status:

COMPLETED

New Oral Anticoagulant Therapy for the Prevention of Blood Clots Following Hip or Knee Replacement Surgery

Lead Sponsor:

Eli Lilly and Company

Conditions:

Total Knee Replacement

Total Hip Replacement

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

Brief Summary

LY517717 (a capsule given by mouth) is a blood thinner that may prevent blood clots from forming in the legs and may prevent those blood clots from traveling to the lungs. Leg and lung blood clots occ...

Eligibility Criteria

Inclusion

  • Are scheduled for total knee or hip replacement surgery (only one side, first time joint replacement)
  • Are at least 18 years of age and no more than 75 years of age.
  • Have a body weight more than 50 kg and less than 120 kg.
  • Sign an approved Eli Lilly and Company informed consent document.

Exclusion

  • Have had hip or knee replacement surgery in the non-surgical leg or any surgical procedure in the surgical leg within 6 months prior to enrollment.
  • Other surgeries (brain, spinal cord, eye within 12 months; chest or abdominal surgery within 1 month).
  • Have taken drugs that might increase possibility of bleeding.
  • Other risk factors for bleeding (bleeding disorders, abnormal results on blood tests, ulcers)
  • Increased risk for blood clots.

Key Trial Info

Start Date :

December 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2005

Estimated Enrollment :

511 Patients enrolled

Trial Details

Trial ID

NCT00074828

Start Date

December 1 2003

End Date

May 1 2005

Last Update

March 31 2008

Active Locations (8)

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Page 1 of 2 (8 locations)

1

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Nedlands, Western Australia, Australia

2

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Vienna, Austria

3

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Brussels, Belgium

4

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Ostrava-Poruba, Czechia