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Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery (ADVANCE-3)

14. april 2014 opdateret af: Bristol-Myers Squibb

A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Hip Replacement Surgery (The Advance-3 Study Apixaban Dosed Orally Versus Anticoagulation With Injectable Enoxaparin to Prevent Venous Thromboembolism)

The purpose of this study is to learn whether apixaban can prevent the blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism) that sometimes occur after hip replacement surgery and to learn how apixaban compares with enoxaparin in preventing these clots. The safety of apixaban will also be studied

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

5407

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1199ACK
        • Local Institution
      • Capital Federal, Buenos Aires, Argentina, C1280AEB
        • Local Institution
      • Capital Federal, Buenos Aires, Argentina, C1425AGP
        • Local Institution
      • Ciudad De Buenos Aires, Buenos Aires, Argentina, C1426BOS
        • Local Institution
      • Coronel Suarez, Buenos Aires, Argentina, B7540GHD
        • Local Institution
      • Monte Grande, Buenos Aires, Argentina, B1842DID
        • Local Institution
  • Australien
    • New South Wales
      • Camperdown, New South Wales, Australien, 2050
        • Local Institution
      • Kogarah, New South Wales, Australien, 2217
        • Local Institution
      • Lismore, New South Wales, Australien, 2480
        • Local Institution
    • Queensland
      • Southport, Queensland, Australien, 4215
        • Local Institution
    • South Australia
      • Bedford Park, South Australia, Australien, 5042
        • Local Institution
    • Victoria
      • Box Hill, Victoria, Australien, 3128
        • Local Institution
      • Malvern, Victoria, Australien, 3144
        • Local Institution
      • Windsor, Victoria, Australien, 3181
        • Local Institution
    • Western Australia
      • Perth, Western Australia, Australien, 6000
        • Local Institution
  • Belgien
      • Antwerp, Belgien, 2020
        • Local Institution
      • Brasschaat, Belgien, 2930
        • Local Institution
      • Genk, Belgien, 3600
        • Local Institution
      • Hasselt, Belgien, 3500
        • Local Institution
      • Leuven, Belgien, 3000
        • Local Institution
  • Canada
      • Quebec, Canada, G1L 3L5
        • Local Institution
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Local Institution
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • Local Institution
      • Cambridge, Ontario, Canada, N1R 7L7
        • Local Institution
      • Chatham, Ontario, Canada, N7L 4T1
        • Local Institution
      • Guelph, Ontario, Canada, N1E 6L9
        • Local Institution
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Local Institution
      • Oshawa, Ontario, Canada, L1J 2J2
        • Local Institution
      • Sarnia, Ontario, Canada, N7T 6H3
        • Local Institution
      • Scarborough, Ontario, Canada, M1S 4T7
        • Local Institution
      • St. Catharines, Ontario, Canada, L2R 7P3
        • Local Institution
      • Stratford, Ontario, Canada, N5A 2N4
        • Local Institution
      • Waterloo, Ontario, Canada, N2J 1C4
        • Local Institution
      • Windsor, Ontario, Canada, N8W 1E6
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Local Institution
  • Danmark
      • Amager, Danmark, 2300
        • Local Institution
      • Frederiksberg, Danmark, 2000
        • Local Institution
      • Herlev, Danmark, 2730
        • Local Institution
      • Horsholm, Danmark, 2970
        • Local Institution
      • Hvidovre, Danmark, 2650
        • Local Institution
      • Kobenhavn Nv, Danmark, 2400
        • Local Institution
      • Silkeborg, Danmark, 8600
        • Local Institution
  • Den Russiske Føderation
      • Chelyabinsk, Den Russiske Føderation, 454021
        • Local Institution
      • Kazan, Den Russiske Føderation, 420029
        • Local Institution
      • Moscow, Den Russiske Føderation, 115522
        • Local Institution
      • Moscow, Den Russiske Føderation, 111539
        • Local Institution
      • Moscow, Den Russiske Føderation, 117292
        • Local Institution
      • Moscow, Den Russiske Føderation, 119415
        • Local Institution
      • Saint Petersburg, Den Russiske Føderation, 199106
        • Local Institution
      • Saint Petersburg, Den Russiske Føderation, 193312
        • Local Institution
      • Saint Petersburg, Den Russiske Føderation, 194354
        • Local Institution
      • Saint Petersburg, Den Russiske Føderation, 195427
        • Local Institution
      • Saint Petersburg, Den Russiske Føderation, 196247
        • Local Institution
      • Samara, Den Russiske Føderation, 443095
        • Local Institution
      • St.Petersburg, Den Russiske Føderation, 192242
        • Local Institution
      • Yaroslavl, Den Russiske Føderation, 150003
        • Local Institution
  • Det Forenede Kongerige
    • Greater London
      • London, Greater London, Det Forenede Kongerige, SE5 9RS
        • Local Institution
    • Lancashire
      • Wigan, Lancashire, Det Forenede Kongerige, WN6 9EP
        • Local Institution
    • Surrey
      • Epsom, Surrey, Det Forenede Kongerige, KT18 7EG
        • Local Institution
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35209
        • West Alabama Research, Llc
      • Birmingham, Alabama, Forenede Stater, 35209
        • Capstone Clinical Trials, Inc
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Martin Bowen Hefley Orthopedics
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Orthoarkansas, P.A.
    • California
      • Sacramento, California, Forenede Stater, 95817
        • UC Davis Medical Center
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80012
        • Colorado Orthopedic Consultants, PC
      • Denver, Colorado, Forenede Stater, 80230
        • Advanced Orthopedic And Sports Medicine Specilists
      • Denver, Colorado, Forenede Stater, 80230
        • Denver-Vail Orthopedics, P.C.
    • Florida
      • Brandon, Florida, Forenede Stater, 33511
        • PAB Clinical Research
      • Clearwater, Florida, Forenede Stater, 33756
        • Research Alliance, Inc.
      • Ft. Lauderdale, Florida, Forenede Stater, 33316
        • Shrock Orthopedic Research
      • Tamarac, Florida, Forenede Stater, 33321
        • Phoenix Clinical Research, LLC
    • Georgia
      • Decatur, Georgia, Forenede Stater, 30033
        • Atlanta Knee And Sports Medicine
    • Idaho
      • Boise, Idaho, Forenede Stater, 83702
        • Americana Orthopedics
      • Meridian, Idaho, Forenede Stater, 83642
        • Bosie Orthopedic Clinic
    • Pennsylvania
      • Altoona, Pennsylvania, Forenede Stater, 16602
        • University Orthopedic Center
    • Texas
      • Lubbock, Texas, Forenede Stater, 79410
        • Gill Orthopedic Center
      • Lubbock, Texas, Forenede Stater, 79410
        • Robert R. King, Md
      • San Antonio, Texas, Forenede Stater, 78217
        • Unlimited Research
  • Frankrig
      • Nice, Frankrig, 06200
        • Local Institution
      • Paris, Frankrig, 75014
        • Local Institution
      • Paris, Frankrig, 75019
        • Local Institution
      • Paris, Frankrig, 75679
        • Local Institution
      • Saint Etienne, Frankrig, 42100
        • Local Institution
      • Saint-Saulve, Frankrig, 59880
        • Local Institution
  • Indien
      • Bangalore, Indien, 560034
        • Local Institution
      • Mangalore, Indien, 575001
        • Local Institution
    • Gujarat
      • Ahmedabad, Gujarat, Indien, 380015
        • Local Institution
    • Punjab
      • Ludhiana, Punjab, Indien, 141001
        • Local Institution
    • Uttar Prsdesh
      • Lucknow, Uttar Prsdesh, Indien, 226003
        • Local Institution
  • Israel
      • Beer Sheva, Israel, 84101
        • Local Institution
      • Haifa, Israel, 31096
        • Local Institution
      • Holon, Israel, 58100
        • Local Institution
      • Kfar-Saba, Israel, 44281
        • Local Institution
      • Zerifin, Israel, 70300
        • Local Institution
  • Kina
    • Beijing
      • Beijing, Beijing, Kina, 100853
        • Local Institution
      • Beijing, Beijing, Kina, 100035
        • Local Institution
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510405
        • Local Institution
    • Shandong
      • Qingdao, Shandong, Kina, 266003
        • Local Institution
    • Shanghai
      • Shanghai, Shanghai, Kina, 200025
        • Local Institution
      • Shanghai, Shanghai, Kina, 200011
        • Local Institution
      • Shanghai, Shanghai, Kina, 200233
        • Local Institution
  • Mexico
      • Aguascalientes, Mexico, 20010
        • Local Institution
      • Chihuahua, Mexico, 31020
        • Local Institution
    • Baja California
      • Tijuana, Baja California, Mexico, 22010
        • Local Institution
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 06726
        • Local Institution
      • Mexico City, Distrito Federal, Mexico, 07760
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 45235
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Local Institution
    • Tamaulipas
      • Cd. Madero, Tamaulipas, Mexico, 89240
        • Local Institution
  • Norge
      • Gjettum, Norge, 1346
        • Local Institution
      • Kongsvinger, Norge, 2212
        • Local Institution
      • Lillehammer, Norge, 2629
        • Local Institution
      • Tonsberg, Norge, 3116
        • Local Institution
      • Tynset, Norge, 2500
        • Local Institution
  • Polen
      • Gdansk, Polen, 80-803
        • Local Institution
      • Lodz, Polen, 91-002
        • Local Institution
      • Szczecin, Polen, 71-252
        • Local Institution
      • Warszawa, Polen, 03-242
        • Local Institution
      • Warszawa, Polen, 02-005
        • Local Institution
      • Wroclaw, Polen, 50-556
        • Local Institution
  • Rumænien
      • Bucharest, Rumænien, 021659
        • Local Institution
      • Cluj Napoca, Rumænien, 400132
        • Local Institution
  • Spanien
      • Badalona-Barcelone, Spanien, 08916
        • Local Institution
      • Barcelona, Spanien, 08035
        • Local Institution
      • Barcelona, Spanien, 08036
        • Local Institution
      • Barcelona, Spanien, 08006
        • Local Institution
      • Barcelona, Spanien, 08024
        • Local Institution
  • Sverige
      • Gothenburg, Sverige, 416 85
        • Local Institution
      • Stockholm, Sverige, 182 88
        • Local Institution
  • Tyskland
      • Frankfurt, Tyskland, 60528
        • Local Institution
      • Frankfurt / Main, Tyskland, 65929
        • Local Institution
      • Rheinfelden, Tyskland, 79618
        • Local Institution
  • Ukraine
      • Cherkassy, Ukraine, 18009
        • Local Institution
      • Chernivtsy, Ukraine, 58013
        • Local Institution
      • Dnipropetrovsk, Ukraine, 49005
        • Local Institution
      • Ivano-Frankivsk, Ukraine, 76008
        • Local Institution
      • Kyiv, Ukraine, 01601
        • Local Institution
      • Kyiv, Ukraine, 04107
        • Local Institution
      • Sevastopol, Ukraine, 99018
        • Local Institution
  • Ungarn
      • Budapest, Ungarn, 1081
        • Local Institution
      • Kecskemet, Ungarn, 6000
        • Local Institution
      • Szeged, Ungarn, 6720
        • Local Institution
      • Szolnok, Ungarn, 5000
        • Local Institution

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Key Inclusion Criteria

  • Patients undergoing elective unilateral total hip replacement or a revision of at least 1 component of a total hip replacement.
  • Patients who were willing and able to undergo bilateral ascending contrast venography
  • Either sex, any race, 18 years and older

Key Exclusion Criteria

  • Known or suspected bleeding or coagulation disorder in the patient or his or her first-degree relative
  • Known or suspected history of heparin-induced thrombocytopenia
  • Known coagulopathy
  • Active bleeding or at high risk for bleeding
  • Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days
  • Active hepatobiliary disease
  • Alcohol and/or substance abuse within the past year
  • Any condition for which surgery or administration of an anticoagulant is contraindicated
  • Two consecutive blood pressure readings within 15 to 30 minutes with supine systolic blood pressure >180 mm Hg or supine diastolic blood pressure >105 mm Hg
  • Clinically significant laboratory abnormalities at the enrollment visit:
  • Hemoglobin <10 g/dL
  • Platelet count <100,000/mm^3
  • Creatinine clearance <30 mL/min, as estimated by the method of Cockcroft and Gault
  • Alanine aminotransferase or aspartate aminotransferase >2*upper limit of normal or a total bilirubin ≥ 1.5*1 (unless an alternative causative factor such as Gilbert's syndrome was identified)
  • Need for ongoing treatment with a parenteral or oral anticoagulant (eg, subjects with mechanical valves, warfarin eligible atrial fibrillation)
  • Current use of dextrans or fibrinolytics
  • Treatment with medications affecting coagulation or platelet function

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Apixaban, 2.5 mg BID plus placebo
Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
Medicin: Apixaban
Oral tablets, 2.5 mg, twice daily, 5weeks
Andre navne:
  • BMS-562247
  • Eliquis®
Medicin: Enoxaparin-matching placebo
Administered as injection
Eksperimentel: Enoxaparin, 40 mg QD plus placebo
Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
Medicin: Enoxaparin
Subcutaneous, 40 mg, once daily, 5 weeks
Andre navne:
  • Lovenox®
Medicin: Apixaban-matching placebo
Administered as oral tablets

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of Composite of Adjudicated Venous Thromboembolic Event (VTE)-Related (Pulmonary Embolism and Symptomatic and Asymptomatic Deep Vein Thrombosis[DVT]) and All-cause Death During the Intended Treatment Period
Tidsramme: Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose
Event rate=Number of events divided by the number of patients evaluated. A mandatory bilateral ascending contrast venogram was to be obtained on Day 35 (± 3). Patients with confirmed symptomatic DVT at any time, or asymptomatic DVT upon venography, were to receive treatment for DVT according to the investigator's standard of care. Signs and symptoms suggestive of VTE included, but were not limited to: 1) lower extremity DVT: erythema, warmth, pain, swelling, tenderness; and 2) PE: pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended Treatment Period started on day of randomization and, for patients who received treatment, ended at the later of 2 days after last dose of study drug or 38 days after the first dose (presurgery) of study drug. For randomized patients who did not receive study drug, the period ended 38 days after randomization.
Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of Composite of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During Intended Treatment Period
Tidsramme: Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose
Event rate=Number of events divided by the number of patients evaluated. Each patient was categorized as having no proximal DVT, having proximal DVT, being nonevaluable for proximal DVT, having no distal DVT, having distal DVT, or being nonevaluable for distal DVT. Adjudication criteria were: Normal=All deep veins were visualized, and there was no intraluminal filling defect (ILFD). ILFD=An area of reduced, or absent filling, at least partially surrounded with contrast medium in ≥ 2 projections or a lack of filling in a vessel in which there was a cut-off that had the configuration of a thrombus. Indeterminate=A lack of filling of a region of the deep vein system, proximal or distal, without the presence of an ILFD elsewhere in the same region. Not Done=A venography was not performed. Proximal DVT was found if any of the proximal veins had an ILFD. Pulmonary embolism was radiographically (angiography, V/Q scan, computed tomography) determined.
Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose
Rates of Adjudicated All-cause Death, VTE-related Death, Pulmonary Embolism (PE), Nonfatal PE, Deep Vein Thrombosis (DVT) (Symptomatic and Asymptomatic), Symptomatic and Asymptomatic Proximal and Distal DVT During the Intended Treatment Period
Tidsramme: Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose
VTE=venous thromboembolic event; VTE-related death=combination of fatal or nonfatal PE and symptomatic or asymptomatic DVT. Event rate=Number of events divided by the number of patients evaluated.
Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose
Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), Major or CRNM, and Any Bleeding During the Treatment Period
Tidsramme: First dose of study drug (presurgery) through 2 days after the last dose of study drug
Event rate=Number of events divided by the number of patients evaluated. Major bleeding event defined as a bleeding event that was 1) Acute clinically overt bleeding accompanied by at least 1 of the following: decrease in hemoglobin of ≥ 2 g/dL over a 24-hour period, transfusion of ≥2 units of packed red blood cells; bleeding that occurred in at least 1 of the following sites: intracranial, intra-spinal, intraocular, pericardial, an operated joint and requires reoperation or intervention, intramuscular with compartment syndrome, or retroperitoneal; 2) Fatal. CRNM was defined as acute clinically overt bleeding that did not satisfy the criteria for a major bleeding event and met at least 1 of the following: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, or hemoptysis. Minor bleeding was defined as an acute clinically overt bleeding event that did not meet the criteria for major bleeding or a CRNM. Fatal bleeding event was defined as bleeding that was the primary
First dose of study drug (presurgery) through 2 days after the last dose of study drug
Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), and Death as Outcome
Tidsramme: First dose of study drug (presurgery) through 30 days after the last dose of study drug
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. All suspected bleeding events were to be reported by the investigator as either an AE or SAE and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood.
First dose of study drug (presurgery) through 30 days after the last dose of study drug
Number of Participants With a Bleeding-related Adverse Event During the Treatment Period
Tidsramme: First dose of study drug (presurgery) through 2 days after the last dose of study drug
All suspected bleeding events were to be reported by the investigator as either an adverse event or serious adverse event or and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. All acute clinically overt bleeding events were adjudicated by the ICAC as a major bleeding event or a clinically relevant nonmajor bleeding event; suspected minor bleeding events were not sent for adjudication.
First dose of study drug (presurgery) through 2 days after the last dose of study drug
Number of Participants With a Bleeding-related Adverse Events During the Treatment Period (Continued)
Tidsramme: First dose of study drug (presurgery) through 2 days after the last dose of study drug
All suspected bleeding events were to be reported by the investigator as either an adverse event or serious adverse event or and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. All acute clinically overt bleeding events were adjudicated by the ICAC as a major bleeding event or a clinically relevant nonmajor bleeding event; suspected minor bleeding events were not sent for adjudication.
First dose of study drug (presurgery) through 2 days after the last dose of study drug
Number of Participants With a Bleeding-related Adverse Event During the Treatment Period (Continued)
Tidsramme: First dose of study drug (presurgery) through 2 days after the last dose of study drug
All suspected bleeding events were to be reported by the investigator as either an adverse event or serious adverse event or and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. All acute clinically overt bleeding events were adjudicated by the ICAC as a major bleeding event or a clinically relevant nonmajor bleeding event; suspected minor bleeding events were not sent for adjudication.
First dose of study drug (presurgery) through 2 days after the last dose of study drug
Number of Participants With Neurologic Adverse Events With Onset During the Treatment Period
Tidsramme: First dose of study drug (presurgery) through 2 days after the last dose of study drug
Neurologic events were based on Medical Dictionary for Regulatory Activities search categories.For new or worsening events that were not related to the site of surgery, additional information was collected on a specific form. In addition, neurology consultation was to be obtained for these patients.
First dose of study drug (presurgery) through 2 days after the last dose of study drug
Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period
Tidsramme: First dose of study drug (presurgery) through 2 days after the last dose of study drug
preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. MA criteria: Hemoglobin: >2 g/dL decrease from preRx or value ≤ 8 g/dL; hematocrit (%): <0.75*preRx; platelet count (*10^9 cells/L): <100,000/mm^3; erythrocytes (*10^6 cells/μL): <0.75*preRx level; leukocytes (*10^3 cells/μL): < 0.75*LLN or >1.25*ULN, or if preRx LLN use < 0.8*preRx or >ULN if preRx >ULN use >1.2*preRx or <LLN; basophils (*10^3 cells/μL): >400/mm^3; eosinophils (*10^3 cells/μL): > 0.75*10^3 cells/μL; lymphocytes (*10^3 cells/μL): >0.75*10^3 cells/μL; monocytes (*10^3 cells/μL): >2000/mm^3; neutrophils (*10^3 cells/μL): <1.0;
First dose of study drug (presurgery) through 2 days after the last dose of study drug
Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)
Tidsramme: First dose of study drug (presurgery) through 2 days after the last dose of study drug
preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. Alanine aminotransferase (ALT) (U/L): >3 *ULN: alkaline phosphatase (ALP) (U/L): >2* ULN; aspartate aminotransferase (ASP) (U/L): >3 *ULN; bilirubin, direct (mg/dL): >2*ULN; bilirubin, total (mg/dL): >2*ULN; BUN (mg/dL): >2*ULN; creatinine (mg/dL): >1.5*ULN; calcium (mg/dL): < 0.8*LLN or >1.2 *ULN, or if preRx <LLN use <0.75* preRx or >ULN if preRx >ULN use > 1.25*preRx or <LLN; chloride (mEq/L): <0.9*LLN or >1.1*ULN, or if preRx <LLN use <0.9*preRx or >ULN if preRx >ULN use >1.1* preRx or <LLN; bicarbonate (mEq/L): < 0.75* LLN or >1.25*ULN, or if preRx <LLN use <0.75*preRx or >ULN if preRx >ULN use >1.25*preRx or <LLN; potassium (mEq/L): < 0.9*LLN or >1.1*ULN, or if preRx <LLN use <0.9*preRx or >ULN if preRx >ULN use >1.1* preRx or < LLN; sodium (mEq/L): <0.95* LLN or >1.05×ULN, or if preRx <LLN use <0.95* predose or >ULN if preRx >ULN use >1.05 *preRx or < LLN.
First dose of study drug (presurgery) through 2 days after the last dose of study drug
Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)
Tidsramme: First dose of study drug (presurgery) through 2 days after the last dose of study drug
preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. Glucose, fasting (mg/dL): <.8*LLN or >1.5*ULN, or if preRx <LLN use <.8*preRx or >ULN if preRx >ULN use >2*preRx or <LLN; protein, total (g/L): If missing preRx use ≥2, or if value ≥4 or preRx =0 or .5 use ≥2, or if preRx=1 use ≥3, or if preRx =2 or 3 use ≥4; creatine kinase (U/L): >5*ULN; uric acid (mg/dL): >.5* ULN, or if preRx >ULN use >2*preRx; blood, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx =2 or 3 use ≥4; glucose, urine : If missing preRx use ≥2, or if value ≥4, or if preRx=0 or .5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; RBC, urine (hpf): If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx dose= 1 use ≥3, or if preRx=2 or 3 use ≥4; WBC, urine (h): If missing preRx use ≥2, or if value ≥4, or if preRx =0 or .5 use ≥2, or if preRx =1 use ≥3, or if preRx=2 or 3 use ≥4.
First dose of study drug (presurgery) through 2 days after the last dose of study drug
Number of Participants With Adverse Events Related to Elevations in Liver Function Test Results With Onset During the Treatment Period
Tidsramme: First dose of study drug (presurgery) through 30 days after the last dose of study drug
Treatment guidelines were provided for jaundice and elevated results of liver function tests.
First dose of study drug (presurgery) through 30 days after the last dose of study drug
Rates of Adjudicated Myocardial Infarction (MI)/Stroke, MI, Stroke, and Thrombocytopenia During the Intended Treatment Period
Tidsramme: Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose
Event rate=Number of events divided by the number of patients evaluated. All suspected events were reported by investigator. Acute MI=the presence of a clinical situation (eg, abnormal history, physical examination, new electrocardiogram changes) suggestive of an MI and at least 1 of the following: elevated creatine kinase (CK)-MB or troponin T or troponin I ≥2*upper limit of normal (ULN); if CK-MB or troponin values not available, total CK ≥2*ULN; or new significant (≥0.04 sec) Q waves in ≥2 contiguous leads. Stroke=a new focal neurologic deficit of sudden onset lasting at least 24 hours that was not due to a readily identifiable nonvascular cause. Adjudication classified each reported stroke as primary hemorrhagic, nonhemorrhagic, infarction with hemorrhagic conversion, or unknown type. Thrombocytopenia=after 3 days as drop in platelet count to <100,000/mm^3 for patients with a baseline value >150,000/mm^3 or a >50% decline, if the baseline value was ≤150,000/mm^3.
Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose

Samarbejdspartnere og efterforskere

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Sponsor

Bristol-Myers Squibb

Publikationer og nyttige links

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Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2007

Primær færdiggørelse (Faktiske)

1. september 2009

Studieafslutning (Faktiske)

1. september 2009

Datoer for studieregistrering

Først indsendt

17. januar 2007

Først indsendt, der opfyldte QC-kriterier

17. januar 2007

Først opslået (Skøn)

18. januar 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. maj 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. april 2014

Sidst verificeret

1. april 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CV185-035

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