NCT00396786|CompletedPhase 2DMC

Dose-ranging Study of Once-daily Regimen of BAY 59-7939 in the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement

ODIXaHIP-OD

Controlled, Double-Blind, Randomized, Dose-ranging Study of Once-daily Regimen of BAY59-7939 in the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement- ODIXaHIP-OD

Bayer ClinicalTrials.gov

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2 other identifiers

11527EudraCT No: 2004-001341-14

Study Type

interventional

Target

877

Locations

13 countries

Sites

Timeline

RegisteredNov 2006

StartedNov 2004

CompletionJul 2005

Brief Summary

The purpose of this study is to assess different doses of a new drug (BAY 59-7939), taken as a tablet, are safe and can help prevent blood clots forming after a hip replacement operation. Patients undergoing hip replacement surgery are at risk of developing blood clots. To reduce this risk treatment to prevent clots forming is routinely given. The current treatments can include injections under the skin or other treatments that need frequent blood tests to monitor levels of drug in the body. Therefore there is a need for new drugs, which are easier to give and need less monitoring.

Trial Health

On Track

Trial Health Score

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

Enrollment

877

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Nov 2004

Shorter than P25 for phase_2

Geographic Reach

13 countries

62 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

8 months study duration

Study Start

First participant enrolled

November 1, 2004

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed

1.4 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2006

Completed

Last Updated

October 28, 2014

Status Verified

October 1, 2014

Enrollment Period

8 months

First QC Date

November 6, 2006

Last Update Submit

October 27, 2014

Conditions

Venous Thromboembolism

Keywords

Prevention of venous thromboembolism

Outcome Measures

Primary Outcomes (1)

Composite Endpoint of Deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE) and Death from all causes
6-10 days after surgery

Secondary Outcomes (5)

Incidence of DVTs (total, proximal, distal)
6-10 days after surgery
Incidence of symptomatic Venous Thrombo Embolisms (VTEs)
6-10 days after surgery
Incidence of major VTE (ie, Proximal DVT, PE or VTE-related death)
6-10 days after surgery
The composite endpoint that results from the primary endpoint by substituting VTE related death for all death
40 days
Incidence of symptomatic VTEs (total, PE, DVT) within 30 days after stop of treatment with the study drug
40 days