Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism - Full Text View

Sponsors and Collaborators:	Bristol-Myers Squibb Pfizer
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00643201

Purpose

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)

Condition	Intervention	Phase
Venous Thrombosis	Drug: Enoxaparin Drug: warfarin Drug: Placebo for apixaban Drug: Placebo for enoxaparin Drug: Placebo for warfarin Drug: apixaban	Phase III

MedlinePlus related topics: Blood Thinners Deep Vein Thrombosis Pulmonary Embolism

Drug Information available for: Warfarin Apixaban Enoxaparin Sodium Warfarin sodium Warfarin potassium

U.S. FDA Resources

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

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:	2900
Study Start Date:	August 2008
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Enoxaparin solution, subcutaneous, 1 mg/kg Q12h until INR ≥2, twice daily 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
2: Experimental	Drug: Placebo for enoxaparin solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2, twice daily 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

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

Exclusion Criteria:

Contraindications for enoxaparin or warfarin
Active bleeding or high risk for serious bleeding
Short life expectancy
Uncontrolled high blood pressure
Significantly impaired kidney or liver function

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643201

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 428 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

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:	CV185-056, EUDRACT: 2007-007867-25
Study First Received:	March 20, 2008
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00643201 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: Secretariat of Health; 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; Singapore: Ministry of Health; China: State Food and Drug Administration

Study placed in the following topic categories:

Pulmonary Embolism
Anticoagulants
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Warfarin
Thrombosis

Enoxaparin
Embolism and Thrombosis
Fibrin Modulating Agents
Respiratory Tract Diseases
Embolism
Lung Diseases
Venous Thrombosis

Additional relevant MeSH terms:

Pulmonary Embolism
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Warfarin
Pharmacologic Actions
Thrombosis

Enoxaparin
Fibrin Modulating Agents
Embolism and Thrombosis
Respiratory Tract Diseases
Embolism
Therapeutic Uses
Lung Diseases
Venous Thrombosis
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009