Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism

Summary

The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)

Conditions

• Venous Thrombosis

Interventions

DRUG

Enoxaparin

solution, subcutaneous, 1 mg/kg Q12h until International normalized ratio (INR) ≥2.

DRUG

warfarin

tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months

DRUG

Placebo for apixaban

tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months

DRUG

Placebo for enoxaparin

solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2.

DRUG

Placebo for warfarin

tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months

DRUG

apixaban

tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months

Sponsors & Collaborators

• Pfizer

  collaborator INDUSTRY

• Bristol-Myers Squibb

  lead INDUSTRY

Principal Investigators

• Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-07-31

Primary Completion

2013-03-31

Completion

2013-03-31

Countries

• United States
• Argentina
• Australia
• Austria
• Brazil
• Canada
• Chile
• China
• Czechia
• Denmark
• France
• Germany
• Hong Kong
• Hungary
• India
• Israel
• Italy
• Malaysia
• Mexico
• Norway
• Poland
• Portugal
• Puerto Rico
• Romania
• Russia
• Singapore
• South Africa
• South Korea
• Spain
• Ukraine
• United Kingdom

Study Locations