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

This study is currently recruiting participants.

Verified by Bristol-Myers Squibb, February 2010

First Received: March 5, 2008 Last Updated: February 3, 2010 History of Changes

Sponsor:	Bristol-Myers Squibb
Collaborator:	Pfizer
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00633893

Purpose

The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)

Condition	Intervention	Phase
Venous Thrombosis	Drug: Apixaban Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Safety and Efficacy Trial Evaluating the Use of Apixaban for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism

Resource links provided by NLM:

MedlinePlus related topics: Deep Vein Thrombosis Pulmonary Embolism

Drug Information available for: Apixaban

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Venous Thromboembolic Recurrence or Death [ Time Frame: upon occurrence during study treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Bleeding [ Time Frame: upon occurrence during study treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	2430
Study Start Date:	May 2008
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 2.5 mg	Drug: Apixaban Tablets, Oral, twice daily, 12 months
2: Experimental 5.0 mg	Drug: Apixaban Tablets, Oral, twice daily, 12 months
3: Active Comparator 0 mg	Drug: Placebo Tablets, Oral, twice daily, 12 months

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and women ≥ 18 years of age;
Clinical diagnosis of DVT or PE;
Anticoagulant treatment completed
No recurrence of VTE

Exclusion Criteria:

Subjects with indications for long-term treatment with a vitamin K antagonist
Active bleeding or high risk for serious bleeding
Short life expectancy
Uncontrolled high blood pressure
Impaired kidney or liver function

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633893

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 459 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Pfizer

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CV185-057, EUDRACT: 2007-004953-27
Study First Received:	March 5, 2008
Last Updated:	February 3, 2010
ClinicalTrials.gov Identifier:	NCT00633893 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration; Canada: Health Canada; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: National Health Surveillance Agency; Chile: Instituto de Salud Publica de Chile; Mexico: Federal Commission for Sanitary Risks Protection; Austria: Federal Office for Safety in Health Care; Denmark: Danish Medicines Agency; France: Ministry of Health; Germany: Ministry of Health; Israel: Ministry of Health; Italy: Ministry of Health; Norway: Directorate for Health and Social Affairs; Spain: Spanish Agency of Medicines; South Africa: Department of Health; Turkey: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Czech Republic: Ministry of Health; Hungary: Ministry of Health, Social and Family Affairs; Poland: Ministry of Health; Russia: Ministry of Health and Social Development of the Russian Federation; Ukraine: Ministry of Health; Australia: Department of Health and Ageing Therapeutic Goods Administration; Hong Kong: Department of Health; India: Central Drugs Standard Control Organization; Korea: Food and Drug Administration; Malaysia: National Pharmaceutical Control Bureau; Taiwan: Department of Health; Romania: National Medicines Agency; Portugal: National Pharmacy and Medicines Institute

Additional relevant MeSH terms:

Embolism and Thrombosis
Pulmonary Embolism
Respiratory Tract Diseases
Embolism
Lung Diseases

Vascular Diseases
Cardiovascular Diseases
Venous Thrombosis
Thrombosis

ClinicalTrials.gov processed this record on February 08, 2010