Efficacy and Safety Study of Apixaban for the 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:
NCT00643201
First received: March 20, 2008
Last updated: April 17, 2014
Last verified: April 2014
  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 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 in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment [ Time Frame: Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early) ] [ Designated as safety issue: Yes ]
    VTE: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants): n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint: events at any time from randomization until end of intended treatment, regardless whether drug treatment was received. All randomized participants with a non-missing primary endpoint were summarized. Missing endpoint = outcomes which could not be documented on or after study Day 154. Participants were categorized to the assigned group regardless of the treatment actually received (intent-to-treat).


Secondary Outcome Measures:
  • Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death [ Time Frame: Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early) ] [ Designated as safety issue: Yes ]
    VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received, ie intent to treat (ITT) principle. Each participant scored as having an event only if they experienced one or more of the elements of the composite. Participants with missing endpoint information excluded.

  • Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or Cardiovascular (CV)-Related Death [ Time Frame: Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early) ] [ Designated as safety issue: No ]
    VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of efficacy evaluable participants, participants with missing endpoint information excluded). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received, ie, ITT principle. Each participant scored as having an event only if the participant experienced one or more of the elements of the composite.

  • Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or VTE-related Death or Major Bleeding [ Time Frame: Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early) ] [ Designated as safety issue: No ]
    VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Major bleeding defined by International Society on Thrombosis and Haemostasis: acute, clinically overt bleeding associated with decrease in hemoglobin (Hgb) of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or bleeding that is fatal . Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint and including those not in the efficacy evaluable population with a bleeding event that occurred during treatment period. Events included regardless of whether or not participant received treatment, ie, ITT principle

  • Incidence of Adjudicated Composite of Recurrent Symptomatic VTE, Myocardial Infarction, Stroke, CV-related Death, Clinically Relevant Non-major (CRNM) Bleeding or Major Bleeding [ Time Frame: Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early) ] [ Designated as safety issue: No ]
    VTE=Nonfatal DVT or nonfatal PE adjudicated by ICAC blinded to treatment. DVT: compression ultrasound and/or venography; PE: spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Major Bleeding = acute, clinically overt bleeding: decrease in Hgb of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or fatal bleeding. CRNM = acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint and including those not in the efficacy evaluable population with a bleeding event that occurred during treatment period). Events included regardless of whether or not treatment was received (ITT).

  • Incidence of Adjudicated Symptomatic Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period [ Time Frame: Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early) ] [ Designated as safety issue: No ]
    DVT adjudicated by an ICAC blinded to treatment. DVT evaluated by: compression ultrasound and/or venography. Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication, intent to treat principle (ITT). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early).

  • Incidence of Adjudicated Symptomatic Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period [ Time Frame: Day 1 to Week 24 + + 2 Days or 355 Days (Discontinued Early) ] [ Designated as safety issue: No ]
    PE adjudicated by an ICAC blinded to treatment. PE: spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication (ITT principle). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early).

  • Incidence of Adjudicated Venous Thromboembolism (VTE)-Related Death During the Intended Treatment Period [ Time Frame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) ] [ Designated as safety issue: No ]
    VTE-related death included: DVT-related death or PE-related death. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of participants in respective treatment groups excluding participants with missing endpoint information). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occur during the intended treatment period regardless of whether or not the participant received study medication (ITT principle).

  • Incidence of Cardiovascular (CV)-Related Death Including VTE-related Death During the Intended Treatment Period [ Time Frame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) ] [ Designated as safety issue: No ]
    VTE-related death included: DVT-related death or PE-related death. All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of participants in respective treatment groups excluding participants with missing endpoint information). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occur during the intended treatment period regardless of whether or not the participant received study medication (ITT principle).

  • Incidence of All-Cause Death During the Intended Treatment Period [ Time Frame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) ] [ Designated as safety issue: No ]
    Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication (ITT principle). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint information).

  • Incidence of Adjudicated Major Bleeding During the Treatment Period in Treated Participants [ Time Frame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) ] [ Designated as safety issue: Yes ]
    All events were adjudicated by an ICAC blinded to treatment. Bleeding defined by International Society on Thrombosis and Haemostasis: Major Bleeding: acute, clinically overt bleeding: decrease in hemoglobin (hgb) of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or fatal bleeding. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.

  • Incidence of Adjudicated Major/CRNM Bleeding During the Treatment Period in Treated Participants [ Time Frame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) ] [ Designated as safety issue: Yes ]
    Major Bleeding = acute, clinically overt bleeding: decrease in hemoglobin of 2 g/dL or more, or bleeding leading to transfusion, or bleeding in a critical site, or fatal bleeding. CRNM = acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. Minor =: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM. All events were adjudicated by an ICAC blinded to treatment. Total bleeding = any of major, or CRNM, or minor bleeding. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of treated (received at least 1 dose of study drug).

  • Incidence of Adjudicated Clinically Relevant Non Major (CRNM) Bleeding During the Treatment Period in Treated Participants [ Time Frame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) ] [ Designated as safety issue: Yes ]
    Bleeding defined by International Society on Thrombosis and Haemostasis: CRNM defined as acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. All events were adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants with event): calculated as n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.

  • Incidence of Adjudicated Minor Bleeding During the Treatment Period in Treated Participants [ Time Frame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) ] [ Designated as safety issue: Yes ]
    Bleeding defined by International Society on Thrombosis and Haemostasis: Minor bleeding: all acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM. All events wre adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants) calculated as n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.

  • Incidence of Adjudicated Total Bleeding During the Treatment Period in Treated Participants [ Time Frame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) ] [ Designated as safety issue: Yes ]
    Bleeding defined by International Society on Thrombosis and Haemostasis: Total Bleeding defined as any of major, CRNM, or minor bleeding. All events were adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.

  • Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Discontinuations Due to AEs and Death During the Treatment Period in Treated Participants [ Time Frame: First dose to last dose of 24 Weeks + 2 days (AEs) or + 30 days (SAEs) or until drug discontinued ] [ Designated as safety issue: Yes ]
    Treated Participants: all who received at least 1 dose of study drug. Participants categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to treatment received. Included all SAEs and AEs with onset from first dose to last dose + 2 days (for AEs) or + 30 days (for SAEs); note; bleeding AEs and SAEs from first dose to last dose + 2 days included. Discontinuations due to AE included all AEs/SAEs from first dose until drug was discontinued. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.

  • Number of Treated Participants With Marked Abnormalities in Hematology Laboratory Tests [ Time Frame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) ] [ Designated as safety issue: Yes ]
    Lower limit of normal (LLN). Upper limit of normal (ULN). Pre-therapy (PreRx). Absolute (Abs) neutrophil count, bands + neutrophils (ANC). Cells per microliter (c/µL). Grams per deciliter (g/dL). Cells per Liter (c/L). Millimeter (MM). White blood cells: < 0.75*LLN, > 1.25*ULN; Hemoglobin: <= 11.5 g/dL (males), <= 9.5 g/dL (females); Hematocrit: <= 37% (males), <= 32% (females); Erythrocytes: <0.75*10^6 c/µL*PreRx; Platelet count: < 75*10^9 c/L, > 700*10^9 c/L; ANC: < 1.00*10^3 c/µL; Abs eosinophils: > 0.750*10^3 c/µL; Abs Basophils: > 400/MM^3; Abs Monocytes> 2000/MM^3; Abs Lymphocytes: < 0.750*10*3 c/ µL, > 7.5*10^3 c/ µL.

  • Number of Treated Participants With Marked Abnormalities in Electrolyte Laboratory Tests [ Time Frame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) ] [ Designated as safety issue: Yes ]
    Bicarbonate milliequivalents/Liter (mEq/L) Low/High: < 0.75*LLN or > 1.25*ULN, or if pre-dose < LLN then use < 0.75*pre-dose or > ULN if pre-dose > ULN then use > 1.25*pre-dose or < LLN; Serum Calcium mg/dL Low/High: < 0.8*LLN or > 1.2*ULN, or if pre-dose < LLN then use < 0.75*pre-dose or > ULN if pre-dose > ULN then use > 1.25*pre-dose or < LLN; Serum Chloride mEq/L: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*pre-dose or > ULN if pre-dose > ULN then use > 1.1*pre-dose or < LLN; Serum Potassium mEq/L: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*pre-dose or > ULN if pre-dose > ULN then use > 1.1*pre-dose or < LLN; Serum Sodium mEq/L: < 0.95*LLN or > 1.05*ULN, or if pre-dose < LLN then use < 0.95*pre-dose or > ULN if pre-dose > ULN then use > 1.05*pre-dose or < LLN.

  • Number of Treated Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests [ Time Frame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) ] [ Designated as safety issue: Yes ]
    Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL High: > 1.5*ULN; Creatinine mg/dL: > 1.5*ULN; Alanine aminotransferase (ALT) U/L: > 3*ULN; Aspartate aminotransferase (AST) U/L: > 3*ULN; Alkaline phosphatase U/L: > 2*ULN; Bilirubin Direct mg/dL: > 1.5*ULN; Bilirubin Total mg/dL: > 2*ULN.

  • Number of Treated Participants With Marked Abnormalities in Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests [ Time Frame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) ] [ Designated as safety issue: Yes ]
    Creatine kinase High: >5*ULN Units/Liter (U/L); Total Protein High/Low: < 0.9 *LLN or > 1.1*ULN, or if pre-dose < LLN then use 0.9* pre-dose or > ULN if pre-dose > ULN then use 1.1 *pre-dose or <LLN; Uric acid High: > 1.5* ULN, or if pre-dose > ULN then use > 2 *pre-dose.

  • Number of Treated Participants With Marked Abnormalities in Urinalysis Laboratory Tests [ Time Frame: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) ] [ Designated as safety issue: Yes ]
    All tests in urine: Glucose: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Protein: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Blood: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Leukocyte esterase: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4;Red blood cells (RBC): If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; White blood cells (WBC): If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4.


Enrollment: 5614
Study Start Date: July 2008
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Apixaban
apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.
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
Other Names:
  • Coumadin
  • BMS-565793
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
Experimental: Enoxaparin + Warfarin
Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until international normalized ratio (INR) ≥2.
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
Other Name: BMS-562247

  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

  Hide Study Locations
Locations
United States, Alabama
Alabama Clinical Therapeutics, Llc
Birmingham, Alabama, United States, 35235
Horizon Research Group, Inc.
Mobile, Alabama, United States, 36608
United States, Arkansas
Fort Smith Lung Center
Fort Smith, Arkansas, United States, 72901
University Of Arkansas For Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Beaver Medical Group
Banning, California, United States, 92220
University Of California San Francisco-Fresno
Fresno, California, United States, 93701
University Of California, Davis Medical Center
Sacramento, California, United States, 95817
Chest Medicine & Critical Care Medical Gr. Inc.
San Diego, California, United States, 92123
Stanford University Medical Center
Stanford, California, United States, 94305
Harbor Ucla Medical Center
Torrance, California, United States, 90509
United States, Colorado
New West Physicians
Golden, Colorado, United States, 80401
Drogue Medical, Llc
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
Dept Of Internal Med, Sect Of Pulmonary & Critical Care Med
New Haven, Connecticut, United States, 06510
United States, District of Columbia
George Washington University Medical Faculty Associates
Washington, District of Columbia, United States, 20037
United States, Florida
Bay Pines Va Healthcare Systems
Bay Pines, Florida, United States, 33744
Daniel G. Lorch, Jr, Md, Cpi
Brandon, Florida, United States, 33511
Research Alliance, Inc.
Clearwater, Florida, United States, 33756
River City Clinical Research
Jacksonville, Florida, United States, 32207
Pasadena Center For Medical Research
St. Petersburg, Florida, United States, 33707
Tampa Clinical Research
Tampa, Florida, United States, 33624
Office Of Michele S. Maholtz Md
Vero Beach, Florida, United States, 32960
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Georgia
Atlanta Pulmonary Group
Atlanta, Georgia, United States, 30342
Atlanta Institute For Medical Research, Inc
Decatur, Georgia, United States, 30030
Chatham Hospitalists
Savannah, Georgia, United States, 31405
United States, Illinois
Gateway Cardiology. P.C
Jerseyville, Illinois, United States, 62052
West Suburban Medical Center
Oak Park, Illinois, United States, 60302
United States, Indiana
Infectious Disease Of Indiana Psc
Carmel, Indiana, United States, 46032
United States, Iowa
Heartland Vascular Medicine And Surgery
Windsor Heights, Iowa, United States, 50324
United States, Kentucky
Kentucky Lung Clinic
Hazard, Kentucky, United States, 41701
Univ. Of Kentucky Dept. Of Surgery
Lexington, Kentucky, United States, 40536
Research Integrity, Llc
Owensboro, Kentucky, United States, 42303
United States, Maine
Pen Bay Medical Center
Rockport, Maine, United States, 04856
United States, Maryland
Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
Medstar Research Health Institute
Baltimore, Maryland, United States, 21237
R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States, 21201
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Hurley Medical Center
Flint, Michigan, United States, 48503
United States, Mississippi
Mississippi Medical Research, Llc
Picayune, Mississippi, United States, 39466
United States, Missouri
University Of Missouri-Columbia
Columbia, Missouri, United States, 65212
Veterans Affairs Medical Center
Kansas City, Missouri, United States, 64128
Washington University School Of Medicine
St Louis, Missouri, United States, 63110
St. John'S Mercy Medical Center
St. Louis, Missouri, United States, 63141
United States, Montana
Mercury Street Medical Group, Pllc
Butte, Montana, United States, 59701
Great Falls Clinic, Llp
Great Falls, Montana, United States, 59405
United States, Nebraska
Internal Medical Associates Of Grand Island, P.C
Grand Island, Nebraska, United States, 68803
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
United States, New Jersey
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
United States, New York
Pulmonary & Critical Care Services, Pc
Albany, New York, United States, 12205
Kaleida Health System
Buffalo, New York, United States, 14209
Richmond University Medical Center
Staten Island, New York, United States, 10310
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Duke University Medical Center
Durham, North Carolina, United States, 27710
Rex Healthcare
Raleigh, North Carolina, United States, 27607
Piedmont Healthcare/Research
Statesville, North Carolina, United States, 28625
Wilmington Medical Research
Wilmington, North Carolina, United States, 28401
Clinical Trials Of America, Inc.
Winston Salem, North Carolina, United States, 27103
United States, North Dakota
Altru Health System Clinic
Grand Forks, North Dakota, United States, 58201
United States, Ohio
Huron Hospital
Cleveland, Ohio, United States, 44112
Remington Davis Inc.
Columbus, Ohio, United States, 43215
United States, Oregon
Oregon Health Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
Greenville Hospital System
Greenville, South Carolina, United States, 29615
Palmetto Clinical Research
Summerville, South Carolina, United States, 29485
United States, Tennessee
Holston Medical Group
Bristol, Tennessee, United States, 37620
Kore Cv Research
Jackson, Tennessee, United States, 38305
United States, Texas
Primecare Medical Group
Houston, Texas, United States, 77024
Cancer Care Centers Of South Texas
San Antonio, Texas, United States, 78229
United States, Utah
University Of Utah Medical Center
Salt Lake City, Utah, United States, 84132
United States, Washington
Lake Washington Vascular, Pllc
Bellevue, Washington, United States, 98004
Franciscan Research Center
Tacoma, Washington, United States, 98405
Argentina
Local Institution
Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, C1180AAX
Local Institution
Rosario, Santa Fe, Argentina, S2000CVB
Local Institution
Rosario, Santa Fe, Argentina, 2000
Local Institution
Rosario, Santa Fe, Argentina, S2000DSV
Local Institution
Buenos Aires, Argentina, C1280AEB
Local Institution
Cordoba, Argentina, 5000
Local Institution
Corrientes, Argentina, 3400
Australia, Australian Capital Territory
Local Institution
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Local Institution
Concord, New South Wales, Australia, 2139
Local Institution
Kogarah, New South Wales, Australia, 2217
Local Institution
Lismore, New South Wales, Australia, 2480
Local Institution
Randwick, New South Wales, Australia, 2031
Australia, Queensland
Local Institution
Herston, Queensland, Australia, 4029
Australia, South Australia
Local Institution
Adelaide, South Australia, Australia, 5000
Local Institution
Bedford Park, South Australia, Australia, 5042
Australia, Tasmania
Local Institution
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Local Institution
Box Hill, Victoria, Australia, 3128
Local Institution
Clayton, Victoria, Australia, 3168
Local Institution
Ringwood East, Victoria, Australia, 3135
Local Institution
Windsor, Victoria, Australia, 3181
Australia, Western Australia
Local Institution
Perth, Western Australia, Australia, 6001
Austria
Local Institution
Graz, Austria, 8036
Local Institution
Innsbruck, Austria, 6020
Local Institution
Vienna, Austria, 1140
Local Institution
Vienna, Austria, 1100
Local Institution
Vienna, Austria, 1160
Local Institution
Vienna, Austria, 1090
Local Institution
Wien, Austria, 1090
Brazil
Local Institution
Belo Horizonte - Mg, Minas Gerais, Brazil, 30150
Local Institution
Curitiba, Parana, Brazil, 80035
Local Institution
Curitiba, Parana, Brazil, 80050
Local Institution
Curitiba, Parana, Brazil, 81520
Local Institution
Curitiba, Parana, Brazil, 80810
Local Institution
Rio Janeiro, Rio De Janeiro, Brazil, 22280
Local Institution
Port Alegre, Rio Grande Do Sul, Brazil, 90020
Local Institution
Porto Alegre, Rio Grande Do Sul, Brazil, 90035
Local Institution
Porto Alegre, Rio Grande Do Sul, Brazil, 90110
Local Institution
Porto Alegre, Rio Grande Do Sul, Brazil, 90610
Local Institution
Botucatu, Sao Paulo, Brazil, 18618
Local Institution
Liberdade, Sao Paulo, Brazil, 01509
Local Institution
Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15090
Local Institution
Sao Bernardo do Campo, SP, Brazil, 09715
Local Institution
Rio De Janeiro, Brazil, 20551
Local Institution
Sao Paulo, Brazil, 01323
Local Institution
Sao Paulo, Brazil, 04005
Local Institution
Sao Paulo, Brazil, 05403
Local Institution
Sao Paulo, Brazil, 04025
Canada, Alberta
Local Institution
Edmonton, Alberta, Canada, T6G 2B7
Local Institution
Edmonton, Alberta, Canada, T5H 4B9
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada, V5Z 1M9
Local Institution
Vancouver, British Columbia, Canada, V6Z 1Y6
Local Institution
Victoria, British Columbia, Canada, V8R 6R5
Canada, Manitoba
Local Institution
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, New Brunswick
Local Institution
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Ontario
Local Institution
Hamilton, Ontario, Canada, L8N 4A6
Local Institution
Hamilton, Ontario, Canada, L8L 2X2
Local Institution
Hamilton, Ontario, Canada, L8S 4K1
Local Institution
Ottawa, Ontario, Canada, K1Y 4E9
Local Institution
Toronto, Ontario, Canada, M5G 2C4
Local Institution
Waterloo, Ontario, Canada, N2J 1C4
Local Institution
Windsor, Ontario, Canada, N8X 5A6
Canada, Quebec
Local Institution
Greenfield Park, Quebec, Canada, J4V 2H1
Local Institution
Montreal, Quebec, Canada, H1T 2M4
Local Institution
St. Jerome, Quebec, Canada, J7Z 5T3
Chile
Local Institution
Punta Arenas, Magallanes Antartica, Chile, 6212296
Local Institution
Independencia, Metropolitana, Chile, XXXXX
Local Institution
Santiago, Metropolitana, Chile, 7600448
Local Institution
Santiago, Metropolitana, Chile, 8330024
Local Institution
Vina Del Mar, Valparaiso, Chile, 2520000
China, Beijing
Local Institution
Beijing, Beijing, China, 100032
Local Institution
Beijing, Beijing, China, 100053
Local Institution
Beijing, Beijing, China, 100029
Local Institution
Beijing, Beijing, China, 100020
Local Institution
Beijing, Beijing, China, 100035
Local Institution
Beijing, Beijing, China, 100038
Local Institution
Beijing, Beijing, China, 100037
Local Institution
Beijing, Beijing, China, 100191
China, Guangdong
Local Institution
Guangzhou, Guangdong, China, 510080
China, Hubei
Local Institution
Wuhan, Hubei, China, 430022
China, Liaoning
Local Institution
Shengyang, Liaoning, China, 110004
China, Shanghai
Local Institution
Shanghai, Shanghai, China, 200127
Local Institution
Shanghai, Shanghai, China, 200032
China, Zhejiang
Local Institution
Hangzhou, Zhejiang, China, 310016
Local Institution
Hangzhou, Zhejiang, China, 130016
China
Local Institution
Xian, China, 710032
Czech Republic
Local Institution
Hradec Kralove, Czech Republic, 500 05
Local Institution
Kladno, Czech Republic, 272 59
Local Institution
Litomysl, Czech Republic, 570 14
Local Institution
Mestec Kralove, Czech Republic, 289 03
Local Institution
Ostrava, Czech Republic, 708 52
Local Institution
Ostrava Vitkovice, Czech Republic, 703 84
Local Institution
Praha 1, Czech Republic, 110 00
Local Institution
Praha 1, Czech Republic, 118 33
Local Institution
Praha 10, Czech Republic, 100 34
Local Institution
Praha 2, Czech Republic, 128 08
Local Institution
Usti Nad Labem, Czech Republic, 401 13
Local Institution
Usti Nad Orlici, Czech Republic, 562 18
Denmark
Local Institution
Arhus C, Denmark, 8000
Local Institution
Hellerup, Denmark, 2900
Local Institution
Herning, Denmark, 7400
Local Institution
Hilleroed, Denmark, 3400
Local Institution
Horsens, Denmark, 8700
Local Institution
Naestved, Denmark, 4700
Local Institution
Silkeborg, Denmark, 8600
France
Local Institution
Angers, France, 49000
Local Institution
Arras, France, 62022
Local Institution
Besancon, France, 25000
Local Institution
Clamart, France, 92141
Local Institution
Clermont-Ferrand Cedex 01, France, 63003
Local Institution
Dijon, France, 21079
Local Institution
Grenoble Cedex 9, France, 38043
Local Institution
Langres Cedex, France, 52206
Local Institution
Le Kremlin-Bicetre, France, 94275
Local Institution
Lille Cedex, France, 59020
Local Institution
Limoges Cedex, France, 87042
Local Institution
Nantes, France, 44093
Local Institution
Paris, France, 75010
Local Institution
Paris, France, 75004
Local Institution
Pierre Benite, France, 69495
Local Institution
Saint-Priest En Jarez, France, 42270
Local Institution
Toulouse cedex 9, France, 31059
Local Institution
Vernon, France, 27200
Germany
Local Institution
Berlin, Germany, 14050
Local Institution
Berlin, Germany, 10117
Local Institution
Berlin, Germany, 12559
Local Institution
Berlin, Germany, 10787
Local Institution
Bochum, Germany, 44791
Local Institution
Cologne, Germany, 50937
Local Institution
Dortmund, Germany, 44137
Local Institution
Dresden, Germany, 01307
Local Institution
Dresden, Germany, 01067
Local Institution
Frankfurt, Germany, 60596
Local Institution
Gottingen, Germany, 37075
Local Institution
Karlsbad, Germany, 76307
Local Institution
Ludwigshafen, Germany, 67063
Local Institution
Mannheim, Germany, 68163
Local Institution
Mannheim, Germany, 68161
Local Institution
Munchen, Germany, 80331
Local Institution
Munich, Germany, 80336
Hong Kong
Local Institution
Pokfulman, Hong Kong, XXXXX
Local Institution
Shatin, N.T, Hong Kong
Hungary
Local Institution
Budapest, Hungary, 1032
Local Institution
Budapest, Hungary, 1125
Local Institution
Budapest, Hungary, 1097
Local Institution
Gyula, Hungary, 5700
Local Institution
Kecskemet, Hungary, 6000
Local Institution
Miskolc, Hungary, 3501
Local Institution
Mosonmagyarovar, Hungary, 9200
Local Institution
Szekesfehervar, Hungary, 8000
Local Institution
Zalaegerszeg, Hungary, 8900
India
Local Institution
Hyderabad, Andhra Pradesh, India, 500034
Local Institution
Hyderabad, Andhra Pradesh, India, 500 082
Local Institution
Ahmedabad, Gujarat, India, 380006
Local Institution
Gurgaon, Haryana, India, 122001
Local Institution
Bangalore, Karnataka, India, 560054
Local Institution
Bengaluru, Karnataka, India, 560017
Local Institution
Manipal, Karnataka, India, 576104
Local Institution
Pune, Maharashtra, India, 411001
Local Institution
Mohali, Punjab, India, 160062
Local Institution
Ludhiana, Tagore Nagar, India, 141001
Local Institution
Chennai, Tamil Nadu, India, 600 006
Local Institution
Bangalore, India, 560052
Local Institution
Bangalore, India, 560099
Local Institution
Pune, India, 411001
Israel
Local Institution
Tiberias, Lower Galillee, Israel, 15208
Local Institution
Afula, Israel, 18101
Local Institution
Ashkelon, Israel, 78278
Local Institution
Hadera, Israel, 38101
Local Institution
Haifa, Israel, 31048
Local Institution
Haifa, Israel, 31096
Local Institution
Holon, Israel, 58100
Local Institution
Jerusalem, Israel, 91031
Local Institution
Jerusalem, Israel, 91120
Local Institution
Kfar Saba, Israel, 44281
Local Institution
Nahariya, Israel, 22100
Local Institution
Petach-Tikva, Israel, 49100
Local Institution
Rehovot, Israel, 76100
Local Institution
Safed, Israel, 13100
Local Institution
Tel Aviv, Israel, 64239
Local Institution
Tel Hashomer, Israel, 52621
Italy
Local Institution
Bologna, Italy, 40138
Local Institution
Castelfranco Veneto (Tv), Italy, 31033
Local Institution
Chieti Scalo, Italy, 66013
Local Institution
Cosenza, Italy, 87100
Local Institution
Milano, Italy, 20132
Local Institution
Padova, Italy, 35128
Local Institution
Palermo, Italy, 90127
Local Institution
Pavia, Italy, 27100
Local Institution
Piacenza, Italy, 29100
Local Institution
Pisa, Italy, 56124
Local Institution
Reggio Emilia, Italy, 42100
Local Institution
Rome, Italy, 00168
Local Institution
Rozzano (Mi), Italy, 20089
Local Institution
San Daniele Del Friuli (Ud), Italy, 33038
Local Institution
Vicenza, Italy, 36100
Local Institution
Vittorio Veneto (Tv), Italy, 31029
Korea, Republic of
Local Institution
Busan, Korea, Republic of, 602-702
Local Institution
Seoul, Korea, Republic of, 137-040
Local Institution
Seoul, Korea, Republic of, 138736
Local Institution
Seoul, Korea, Republic of, 120752
Malaysia
Local Institution
Georgetown, Penang, Malaysia, 10350
Local Institution
Ipoh, Perak, Malaysia, 30990
Local Institution
Kuala Lumpur, Malaysia, 50586
Local Institution
Melaka, Malaysia, 75400
Mexico
Local Institution
Tijuana, Baja California, Mexico, 22500
Local Institution
Leon, Guanajuato, Mexico, 37320
Local Institution
Guadalajara, Jalisco, Mexico, 44280
Local Institution
Zapopan, Jalisco, Mexico, 45170
Local Institution
Zapopan, Jalisco, Mexico, 45200
Local Institution
Monterrey, Nuevo Leon, Mexico, 64718
Local Institution
Monterrey, Nuevo Leon, Mexico, 64000
Local Institution
Xalapa, Veracruz, Mexico, 91020
Local Institution
Aguascalientes, Mexico, 20230
Local Institution
Durango, Mexico, 34080
Norway
Local Institution
Alesund, Norway, 6017
Local Institution
Fredrikstad, Norway, 1606
Local Institution
Gjettum, Norway, 1346
Local Institution
Gjovik, Norway, 2819
Local Institution
Hamar, Norway, 2318
Local Institution
Oslo, Norway, 0319
Local Institution
Oslo, Norway, 0456
Local Institution
Oslo, Norway, 0407
Local Institution
Trondheim, Norway, 7006
Local Institution
Tynset, Norway, 2500
Poland
Local Institution
Bialystok, Poland, 15-276
Local Institution
Bydgoszcz, Poland, 85-681
Local Institution
Bydgoszcz, Poland, 85-168
Local Institution
Gdansk, Poland, 80-803
Local Institution
Gdynia, Poland, 81-348
Local Institution
Lodz, Poland, 90-153
Local Institution
Lublin, Poland, 20-718
Local Institution
Lublin, Poland, 20-081
Local Institution
Poznan, Poland, 61-848
Local Institution
Przeworsk, Poland, 37-200
Local Institution
Szczecin, Poland, 70-111
Local Institution
Warsaw, Poland, 02-005
Local Institution
Warsawa, Poland, 02-776
Local Institution
Warszawa, Poland, 01-138
Local Institution
Wroclaw, Poland, 51-124
Local Institution
Wroclaw, Poland, 50-981
Portugal
Local Institution
Coimbra, Portugal, 3004-548
Local Institution
Guarda, Portugal, 6301-857
Local Institution
Lisboa, Portugal, 1769-001
Local Institution
Lisboa, Portugal, 1169-050
Puerto Rico
Local Institution
San Juan, Puerto Rico, 00921
Romania
Local Institution
Baia Mare, Romania, 430031
Local Institution
Bucharest, Romania, 050098
Local Institution
Bucharest, Romania, 022328
Local Institution
Bucharest, Romania, 030171
Local Institution
Targu Mures, Romania, 540136
Russian Federation
Local Institution
Arkhangelsk, Russian Federation, 163045
Local Institution
Chelyabinsk, Russian Federation, 454136
Local Institution
Kazan, Russian Federation, 420101
Local Institution
Moscow, Russian Federation, 117292
Local Institution
Moscow, Russian Federation, 109386
Local Institution
Moscow, Russian Federation, 121359
Local Institution
Moscow, Russian Federation, 115280
Local Institution
Moscow, Russian Federation, 115093
Local Institution
Moscow, Russian Federation, 127473
Local Institution
Moscow, Russian Federation, 119049
Local Institution
Moscow, Russian Federation, 121552
Local Institution
Moscow, Russian Federation, 111539
Local Institution
Novosibirsk, Russian Federation, 630090
Local Institution
Rostov-On Don, Russian Federation, 344022
Local Institution
Ryazan, Russian Federation, 390026
Local Institution
Saint Petersburg, Russian Federation, 197022
Local Institution
Saint Petersburg, Russian Federation, 192242
Local Institution
Saint-Petersburg, Russian Federation, 197341
Local Institution
Saint-Petersburg, Russian Federation, 199106
Local Institution
Saint-Petersburg, Russian Federation, 196247
Local Institution
Saratov, Russian Federation, 410012
Local Institution
St Petersburg, Russian Federation, 194044
Local Institution
Yaroslavl, Russian Federation, 150062
Singapore
Local Institution
Singapore, Singapore, 529889
Local Institution
Singapore, Singapore, 169608
Local Institution
Singapore, Singapore, 308433
South Africa
Local Institution
Bioemfontein, Free State, South Africa, 9301
Local Institution
Centurion, Gauteng, South Africa, 0157
Local Institution
Parktown, Gauteng, South Africa, 2193
Local Institution
Pretoria, Gauteng, South Africa, 0084
Local Institution
Durban, Kwa Zulu Natal, South Africa, 4001
Local Institution
Pietermaritzburg, Kwa Zulu Natal, South Africa, 3201
Local Institution
Bellville, Western Cape, South Africa, 7530
Local Institution
George, Western Cape, South Africa, 6529
Local Institution
Somerset West, Western Cape, South Africa, 7130
Local Institution
Worcester, Western Cape, South Africa, 6850
Spain
Local Institution
Torrevieja, Alicante, Spain, 03186
Local Institution
Getafe, Spain, 28905
Local Institution
L'Hospitalet De Llobregat, Spain, 08907
Local Institution
Leon, Spain, 24008
Local Institution
Madrid, Spain, 28029
Local Institution
Madrid, Spain, 28007
Local Institution
Madrid, Spain, 28041
Local Institution
Malaga, Spain, 29010
Local Institution
Mourente, Spain, 36071
Local Institution
Tarragona, Spain, 43007
Ukraine
Local Institution
Chernihiv, Ukraine, 14034
Local Institution
Dnipropetrovsk, Ukraine, 49000
Local Institution
Donetsk, Ukraine, 83045
Local Institution
Ivano-Frankivsk, Ukraine, 76008
Local Institution
Ivano-Frankivsk, Ukraine, 76018
Local Institution
Kharkiv, Ukraine, 61018
Local Institution
Kyiv, Ukraine, 03680
Local Institution
Lviv, Ukraine, 79010
Local Institution
Odesa, Ukraine, 65117
Local Institution
Ternopil, Ukraine, 46000
Local Institution
Vinnytsia, Ukraine, 21018
Local Institution
Zaporizhzhia, Ukraine, 69035
United Kingdom
Local Institution
Livingston, West Lothian, United Kingdom, EH54 7BH
Sponsors and Collaborators
Bristol-Myers Squibb
Pfizer
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
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: NCT00643201     History of Changes
Other Study ID Numbers: CV185-056, EUDRACT: 2007-007867-25
Study First Received: March 20, 2008
Results First Received: March 4, 2014
Last Updated: April 17, 2014
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 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
Singapore: Ministry of Health
China: Food and Drug Administration

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
Warfarin
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 22, 2014