Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery

Daiichi Sankyo Co., Ltd.92 enrolled

Overview

The objective of this study is to evaluate the safety and efficacy of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective hip fracture surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Venous Thromboembolism

Interventions

DU-176b (edoxaban)DRUG

Enoxaparin sodium 20mgDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who are scheduled to undergo surgery within 10 days for fracture of inner or outer femoral neck (trochanteric and subtrochanteric) Exclusion Criteria: * Subjects with risks of hemorrhage * Subjects with thrombolic risks * Subjects who weigh less than 40 kg * Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant

Locations (1)

Unnamed facility

Osaka, Japan

Outcomes

Primary Outcomes

The Incidence of Major or Clinically Relevant Non-major Bleeding

Bleeding events during the period from the start of treatment with the study drug (study treatment) to the day of the follow-up examination were assessed as the primary endpoints.

Time frame: 2 weeks

Secondary Outcomes

Proportion of Subjects With Venous Thromboembolism Events.

Time frame: 2 weeks

Data from ClinicalTrials.gov

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