NCT00097357|CompletedPhase 2

BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery

A Phase 2 Randomized, Double-Blinded (BMS-562247 and Enoxaparin), Active-Controlled (Enoxaparin and Warfarin), Parallel-Arm, Dose-Response Study of the Oral Factor Xa Inhibitor BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery

Bristol-Myers Squibb ClinicalTrials.gov

Compare

1 other identifier

CV185-010

Study Type

interventional

Target

1,238

Locations

9 countries

Sites

147

Timeline

RegisteredNov 2004

StartedOct 2004

CompletionDec 2005

Brief Summary

The purpose of this study is to learn if BMS-562247 can prevent blood clots in the legs and lungs in men and women following unilateral total knee replacement surgery. The safety of this treatment will also be studied.

Trial Health

On Track

Trial Health Score

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

Enrollment

1,238

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Oct 2004

Shorter than P25 for phase_2

Geographic Reach

9 countries

147 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

1.2 years study duration

Study Start

First participant enrolled

October 1, 2004

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2004

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2004

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed

Last Updated

March 2, 2010

Status Verified

November 1, 2008

Enrollment Period

1.2 years

First QC Date

November 22, 2004

Last Update Submit

February 27, 2010

Conditions

Venous Thrombosis Pulmonary Embolism

Keywords

Prevention of deep vein thrombosis and pulmonary embolismPreventive therapy

Outcome Measures

Primary Outcomes (1)

Determine the dose-response relationship among the 3 QD and 3 BID doses of BMS-562247 on the composite endpoint of adjudicated VTE events and all-cause death in subjects treated with study medication for 12 +/-2 days following surgery
throughout the study

Secondary Outcomes (4)

Assess the effect of QD and BID dose of BMS-562247 vs subcutaneous 30 mg q12h enoxaparin and warfarin on the composite endpoint of adjudication VTE events and all-cause death in subjects treated for 12 +/-2 days following surgery
throughout the study
Assess the effect of each QD and BID dose of BMS-562247 versus subcutaneous 30 mg q12h enoxaparin and oral warfarin on the incidence of adjudicated major bleeding events in subjects treated with study medication for 12 +/-2 days following surgery
throughout the study
Assess the effect of each QD and BID dose of BMS-562247 versus subcutaneous 30 mg q12h enoxaparin and oral warfarin on the incidence of adjudicated minor bleeding events in subjects treated with study medication for 12 +/-2 days following surgery
throughout the study
To determine the pharmacokinetic (PK) profile of BMS-562247 and the relationship to dose and dose schedule
throughout the study