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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00074828




Registration number
NCT00074828
Ethics application status
Date submitted
19/12/2003
Date registered
23/12/2003
Date last updated
31/03/2008

Titles & IDs
Public title
New Oral Anticoagulant Therapy for the Prevention of Blood Clots Following Hip or Knee Replacement Surgery
Scientific title
A Comparison of the Oral Anticoagulant LY517717 Difumarate to Subcutaneous Enoxaparin for the Prevention of Venous Thromboembolic Events (VTE) Post-Total Hip Replacement (THR) and Post-Total Knee Replacement (TKR) Surgery
Secondary ID [1] 0 0
H8G-MC-EPBB
Secondary ID [2] 0 0
8113
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Replacement 0 0
Total Hip Replacement 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: A -

Active comparator: B -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy of LY517717 to enoxaparin in the prevention of VTEs measured by the proportion of patients with VTE event (DVT and/or PE) as confirmed by bilateral venography or on clinical assessment
Timepoint [1] 0 0
end of study drug administration
Secondary outcome [1] 0 0
Safety and tolerability, major and minor bleeding, death due to VTE, effect on QTc duration, AEs and SAEs, hepatobiliary and other safety lab parameters
Timepoint [1] 0 0
baseline, daily during therapy, at follow up visit
Secondary outcome [2] 0 0
Pharmacokinetics and pharmacodynamics
Timepoint [2] 0 0
predose, daily during therapy
Secondary outcome [3] 0 0
Compare the effect of LY517717 versus enoxaparin measured by DVT, Proximal DVT, Distal DVT and PE
Timepoint [3] 0 0
end of study drug administration
Secondary outcome [4] 0 0
Compare the effect of LY517717 versus enoxaparin with confirmed VTE
Timepoint [4] 0 0
end of study drug administration
Secondary outcome [5] 0 0
Compare the effect of LY517717 versus enoxaparin measured by all confirmed VTEs and /or clinically suspected and confirmed VTE
Timepoint [5] 0 0
through follow up

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2005
Sample size
Target
Accrual to date
Final
511
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
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
Recruitment postcode(s) [1] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Ostrava-Poruba
Country [4] 0 0
Germany
State/province [4] 0 0
Aachen
Country [5] 0 0
Hungary
State/province [5] 0 0
Kecskemet
Country [6] 0 0
Italy
State/province [6] 0 0
Perugia
Country [7] 0 0
Poland
State/province [7] 0 0
Bydgoszcz

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
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 occur commonly after patients have surgery to replace a hip or knee joint. These clots often occur while patients are in bed in the hospital after hip or knee joint surgery. The purpose of this study is to test if different dose strengths (amount of drug in the capsules) of LY517717 can prevent blood clots from forming and to determine if LY517717 is safe. This study will compare LY517717 to enoxaparin, another blood thinner. Enoxaparin is one of the standard medications given after hip or knee joint surgery.
Trial website
https://clinicaltrials.gov/study/NCT00074828
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00074828