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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 aktualisiert von: 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

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

5407

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Argentinien
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentinien, C1199ACK
        • Local Institution
      • Capital Federal, Buenos Aires, Argentinien, C1280AEB
        • Local Institution
      • Capital Federal, Buenos Aires, Argentinien, C1425AGP
        • Local Institution
      • Ciudad De Buenos Aires, Buenos Aires, Argentinien, C1426BOS
        • Local Institution
      • Coronel Suarez, Buenos Aires, Argentinien, B7540GHD
        • Local Institution
      • Monte Grande, Buenos Aires, Argentinien, 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
  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Local Institution
      • Beijing, Beijing, China, 100035
        • Local Institution
    • Guangdong
      • Guangzhou, Guangdong, China, 510405
        • Local Institution
    • Shandong
      • Qingdao, Shandong, China, 266003
        • Local Institution
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Local Institution
      • Shanghai, Shanghai, China, 200011
        • Local Institution
      • Shanghai, Shanghai, China, 200233
        • Local Institution
  • Deutschland
      • Frankfurt, Deutschland, 60528
        • Local Institution
      • Frankfurt / Main, Deutschland, 65929
        • Local Institution
      • Rheinfelden, Deutschland, 79618
        • Local Institution
  • Dänemark
      • Amager, Dänemark, 2300
        • Local Institution
      • Frederiksberg, Dänemark, 2000
        • Local Institution
      • Herlev, Dänemark, 2730
        • Local Institution
      • Horsholm, Dänemark, 2970
        • Local Institution
      • Hvidovre, Dänemark, 2650
        • Local Institution
      • Kobenhavn Nv, Dänemark, 2400
        • Local Institution
      • Silkeborg, Dänemark, 8600
        • Local Institution
  • Frankreich
      • Nice, Frankreich, 06200
        • Local Institution
      • Paris, Frankreich, 75014
        • Local Institution
      • Paris, Frankreich, 75019
        • Local Institution
      • Paris, Frankreich, 75679
        • Local Institution
      • Saint Etienne, Frankreich, 42100
        • Local Institution
      • Saint-Saulve, Frankreich, 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
  • Kanada
      • Quebec, Kanada, G1L 3L5
        • Local Institution
    • Alberta
      • Edmonton, Alberta, Kanada, T6G 2B7
        • Local Institution
    • Ontario
      • Ajax, Ontario, Kanada, L1S 2J5
        • Local Institution
      • Cambridge, Ontario, Kanada, N1R 7L7
        • Local Institution
      • Chatham, Ontario, Kanada, N7L 4T1
        • Local Institution
      • Guelph, Ontario, Kanada, N1E 6L9
        • Local Institution
      • Newmarket, Ontario, Kanada, L3Y 5G8
        • Local Institution
      • Oshawa, Ontario, Kanada, L1J 2J2
        • Local Institution
      • Sarnia, Ontario, Kanada, N7T 6H3
        • Local Institution
      • Scarborough, Ontario, Kanada, M1S 4T7
        • Local Institution
      • St. Catharines, Ontario, Kanada, L2R 7P3
        • Local Institution
      • Stratford, Ontario, Kanada, N5A 2N4
        • Local Institution
      • Waterloo, Ontario, Kanada, N2J 1C4
        • Local Institution
      • Windsor, Ontario, Kanada, N8W 1E6
        • Local Institution
    • Quebec
      • Montreal, Quebec, Kanada, H3G 1A4
        • Local Institution
  • Mexiko
      • Aguascalientes, Mexiko, 20010
        • Local Institution
      • Chihuahua, Mexiko, 31020
        • Local Institution
    • Baja California
      • Tijuana, Baja California, Mexiko, 22010
        • Local Institution
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexiko, 06726
        • Local Institution
      • Mexico City, Distrito Federal, Mexiko, 07760
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Mexiko, 45235
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexiko, 64460
        • Local Institution
    • Tamaulipas
      • Cd. Madero, Tamaulipas, Mexiko, 89240
        • Local Institution
  • Norwegen
      • Gjettum, Norwegen, 1346
        • Local Institution
      • Kongsvinger, Norwegen, 2212
        • Local Institution
      • Lillehammer, Norwegen, 2629
        • Local Institution
      • Tonsberg, Norwegen, 3116
        • Local Institution
      • Tynset, Norwegen, 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
  • Rumänien
      • Bucharest, Rumänien, 021659
        • Local Institution
      • Cluj Napoca, Rumänien, 400132
        • Local Institution
  • Russische Föderation
      • Chelyabinsk, Russische Föderation, 454021
        • Local Institution
      • Kazan, Russische Föderation, 420029
        • Local Institution
      • Moscow, Russische Föderation, 115522
        • Local Institution
      • Moscow, Russische Föderation, 111539
        • Local Institution
      • Moscow, Russische Föderation, 117292
        • Local Institution
      • Moscow, Russische Föderation, 119415
        • Local Institution
      • Saint Petersburg, Russische Föderation, 199106
        • Local Institution
      • Saint Petersburg, Russische Föderation, 193312
        • Local Institution
      • Saint Petersburg, Russische Föderation, 194354
        • Local Institution
      • Saint Petersburg, Russische Föderation, 195427
        • Local Institution
      • Saint Petersburg, Russische Föderation, 196247
        • Local Institution
      • Samara, Russische Föderation, 443095
        • Local Institution
      • St.Petersburg, Russische Föderation, 192242
        • Local Institution
      • Yaroslavl, Russische Föderation, 150003
        • Local Institution
  • Schweden
      • Gothenburg, Schweden, 416 85
        • Local Institution
      • Stockholm, Schweden, 182 88
        • 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
  • 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
  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten, 35209
        • West Alabama Research, Llc
      • Birmingham, Alabama, Vereinigte Staaten, 35209
        • Capstone Clinical Trials, Inc
    • Arkansas
      • Little Rock, Arkansas, Vereinigte Staaten, 72205
        • Martin Bowen Hefley Orthopedics
      • Little Rock, Arkansas, Vereinigte Staaten, 72205
        • Orthoarkansas, P.A.
    • California
      • Sacramento, California, Vereinigte Staaten, 95817
        • UC Davis Medical Center
    • Colorado
      • Aurora, Colorado, Vereinigte Staaten, 80012
        • Colorado Orthopedic Consultants, PC
      • Denver, Colorado, Vereinigte Staaten, 80230
        • Advanced Orthopedic And Sports Medicine Specilists
      • Denver, Colorado, Vereinigte Staaten, 80230
        • Denver-Vail Orthopedics, P.C.
    • Florida
      • Brandon, Florida, Vereinigte Staaten, 33511
        • PAB Clinical Research
      • Clearwater, Florida, Vereinigte Staaten, 33756
        • Research Alliance, Inc.
      • Ft. Lauderdale, Florida, Vereinigte Staaten, 33316
        • Shrock Orthopedic Research
      • Tamarac, Florida, Vereinigte Staaten, 33321
        • Phoenix Clinical Research, LLC
    • Georgia
      • Decatur, Georgia, Vereinigte Staaten, 30033
        • Atlanta Knee And Sports Medicine
    • Idaho
      • Boise, Idaho, Vereinigte Staaten, 83702
        • Americana Orthopedics
      • Meridian, Idaho, Vereinigte Staaten, 83642
        • Bosie Orthopedic Clinic
    • Pennsylvania
      • Altoona, Pennsylvania, Vereinigte Staaten, 16602
        • University Orthopedic Center
    • Texas
      • Lubbock, Texas, Vereinigte Staaten, 79410
        • Gill Orthopedic Center
      • Lubbock, Texas, Vereinigte Staaten, 79410
        • Robert R. King, Md
      • San Antonio, Texas, Vereinigte Staaten, 78217
        • Unlimited Research
  • Vereinigtes Königreich
    • Greater London
      • London, Greater London, Vereinigtes Königreich, SE5 9RS
        • Local Institution
    • Lancashire
      • Wigan, Lancashire, Vereinigtes Königreich, WN6 9EP
        • Local Institution
    • Surrey
      • Epsom, Surrey, Vereinigtes Königreich, KT18 7EG
        • Local Institution

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver 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)
Arzneimittel: Apixaban
Oral tablets, 2.5 mg, twice daily, 5weeks
Andere Namen:
  • BMS-562247
  • Eliquis®
Arzneimittel: Enoxaparin-matching placebo
Administered as injection
Experimental: Enoxaparin, 40 mg QD plus placebo
Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
Arzneimittel: Enoxaparin
Subcutaneous, 40 mg, once daily, 5 weeks
Andere Namen:
  • Lovenox®
Arzneimittel: Apixaban-matching placebo
Administered as oral tablets

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

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Sponsor

Bristol-Myers Squibb

Publikationen und hilfreiche Links

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Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. März 2007

Primärer Abschluss (Tatsächlich)

1. September 2009

Studienabschluss (Tatsächlich)

1. September 2009

Studienanmeldedaten

Zuerst eingereicht

17. Januar 2007

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. Januar 2007

Zuerst gepostet (Schätzen)

18. Januar 2007

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

14. Mai 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. April 2014

Zuletzt verifiziert

1. April 2014

Mehr Informationen

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Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CV185-035

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