NCT00074828

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 Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
511

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2003

Shorter than P25 for phase_2

Geographic Reach
7 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2003

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
Last Updated

March 31, 2008

Status Verified

March 1, 2008

First QC Date

December 19, 2003

Last Update Submit

March 27, 2008

Conditions

Total Knee ReplacementTotal Hip Replacement

Keywords

electiveprimary unilateral

Outcome Measures

Primary Outcomes (1)

  • 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

    end of study drug administration

Secondary Outcomes (5)

  • Safety and tolerability, major and minor bleeding, death due to VTE, effect on QTc duration, AEs and SAEs, hepatobiliary and other safety lab parameters

    baseline, daily during therapy, at follow up visit

  • Pharmacokinetics and pharmacodynamics

    predose, daily during therapy

  • Compare the effect of LY517717 versus enoxaparin measured by DVT, Proximal DVT, Distal DVT and PE

    end of study drug administration

  • Compare the effect of LY517717 versus enoxaparin with confirmed VTE

    end of study drug administration

  • Compare the effect of LY517717 versus enoxaparin measured by all confirmed VTEs and /or clinically suspected and confirmed VTE

    through follow up

Study Arms (2)

A

EXPERIMENTAL
Drug: LY517717

B

ACTIVE COMPARATOR
Drug: enoxaparin

Interventions

LY517717DRUG
A
enoxaparinDRUG
B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

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

Location

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

Location

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

Location

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

Location

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.

Aachen, Germany

Location

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.

Kecskemét, Hungary

Location

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.

Perugia, Italy

Location

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.

Bydgoszcz, Poland

Location

Related Links

MeSH Terms

Interventions

LY517717Enoxaparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 19, 2003

First Posted

December 23, 2003

Study Start

December 1, 2003

Study Completion

May 1, 2005

Last Updated

March 31, 2008

Record last verified: 2008-03

Locations

BE(1)DE(1)AU(1)CZ(1)IT(1)PL(1)HU(1)