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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00633893
First received: March 5, 2008
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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:

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 ]

Enrollment: 316
Study Start Date: May 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
2.5 mg
 Drug: Apixaban
Tablets, Oral, twice daily, 12 months
Other Name: BMS-562247
Experimental: 2
5.0 mg
 Drug: Apixaban
Tablets, Oral, twice daily, 12 months
Other Name: BMS-562247
Active Comparator: 3
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

  Show 429 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Pfizer
Investigators
Study Director: Bristol-Myers Squibb 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 by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00633893     History of Changes
Other Study ID Numbers: CV185-057, EUDRACT: 2007-004953-27
Study First Received: March 5, 2008
Last Updated: November 6, 2012
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 of Health
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 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
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Thromboembolism

ClinicalTrials.gov processed this record on May 16, 2013