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

2014年4月14日 更新者：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

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

5407

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Alabama
      • Birmingham、Alabama、アメリカ、35209
        • West Alabama Research, Llc
      • Birmingham、Alabama、アメリカ、35209
        • Capstone Clinical Trials, Inc
    • Arkansas
      • Little Rock、Arkansas、アメリカ、72205
        • Martin Bowen Hefley Orthopedics
      • Little Rock、Arkansas、アメリカ、72205
        • Orthoarkansas, P.A.
    • California
      • Sacramento、California、アメリカ、95817
        • UC Davis Medical Center
    • Colorado
      • Aurora、Colorado、アメリカ、80012
        • Colorado Orthopedic Consultants, PC
      • Denver、Colorado、アメリカ、80230
        • Advanced Orthopedic And Sports Medicine Specilists
      • Denver、Colorado、アメリカ、80230
        • Denver-Vail Orthopedics, P.C.
    • Florida
      • Brandon、Florida、アメリカ、33511
        • PAB Clinical Research
      • Clearwater、Florida、アメリカ、33756
        • Research Alliance, Inc.
      • Ft. Lauderdale、Florida、アメリカ、33316
        • Shrock Orthopedic Research
      • Tamarac、Florida、アメリカ、33321
        • Phoenix Clinical Research, LLC
    • Georgia
      • Decatur、Georgia、アメリカ、30033
        • Atlanta Knee And Sports Medicine
    • Idaho
      • Boise、Idaho、アメリカ、83702
        • Americana Orthopedics
      • Meridian、Idaho、アメリカ、83642
        • Bosie Orthopedic Clinic
    • Pennsylvania
      • Altoona、Pennsylvania、アメリカ、16602
        • University Orthopedic Center
    • Texas
      • Lubbock、Texas、アメリカ、79410
        • Gill Orthopedic Center
      • Lubbock、Texas、アメリカ、79410
        • Robert R. King, Md
      • San Antonio、Texas、アメリカ、78217
        • Unlimited Research
  • アルゼンチン
    • Buenos Aires
      • Capital Federal、Buenos Aires、アルゼンチン、C1199ACK
        • Local Institution
      • Capital Federal、Buenos Aires、アルゼンチン、C1280AEB
        • Local Institution
      • Capital Federal、Buenos Aires、アルゼンチン、C1425AGP
        • Local Institution
      • Ciudad De Buenos Aires、Buenos Aires、アルゼンチン、C1426BOS
        • Local Institution
      • Coronel Suarez、Buenos Aires、アルゼンチン、B7540GHD
        • Local Institution
      • Monte Grande、Buenos Aires、アルゼンチン、B1842DID
        • Local Institution
  • イギリス
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      • London、Greater London、イギリス、SE5 9RS
        • Local Institution
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      • Epsom、Surrey、イギリス、KT18 7EG
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  • イスラエル
      • Beer Sheva、イスラエル、84101
        • Local Institution
      • Haifa、イスラエル、31096
        • Local Institution
      • Holon、イスラエル、58100
        • Local Institution
      • Kfar-Saba、イスラエル、44281
        • Local Institution
      • Zerifin、イスラエル、70300
        • Local Institution
  • インド
      • Bangalore、インド、560034
        • Local Institution
      • Mangalore、インド、575001
        • Local Institution
    • Gujarat
      • Ahmedabad、Gujarat、インド、380015
        • Local Institution
    • Punjab
      • Ludhiana、Punjab、インド、141001
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    • Uttar Prsdesh
      • Lucknow、Uttar Prsdesh、インド、226003
        • Local Institution
  • ウクライナ
      • Cherkassy、ウクライナ、18009
        • Local Institution
      • Chernivtsy、ウクライナ、58013
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      • Ivano-Frankivsk、ウクライナ、76008
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      • Kyiv、ウクライナ、01601
        • Local Institution
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      • Sevastopol、ウクライナ、99018
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  • オーストラリア
    • New South Wales
      • Camperdown、New South Wales、オーストラリア、2050
        • Local Institution
      • Kogarah、New South Wales、オーストラリア、2217
        • Local Institution
      • Lismore、New South Wales、オーストラリア、2480
        • Local Institution
    • Queensland
      • Southport、Queensland、オーストラリア、4215
        • Local Institution
    • South Australia
      • Bedford Park、South Australia、オーストラリア、5042
        • Local Institution
    • Victoria
      • Box Hill、Victoria、オーストラリア、3128
        • Local Institution
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    • Western Australia
      • Perth、Western Australia、オーストラリア、6000
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  • カナダ
      • Quebec、カナダ、G1L 3L5
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    • Alberta
      • Edmonton、Alberta、カナダ、T6G 2B7
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    • Ontario
      • Ajax、Ontario、カナダ、L1S 2J5
        • Local Institution
      • Cambridge、Ontario、カナダ、N1R 7L7
        • Local Institution
      • Chatham、Ontario、カナダ、N7L 4T1
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      • Guelph、Ontario、カナダ、N1E 6L9
        • Local Institution
      • Newmarket、Ontario、カナダ、L3Y 5G8
        • Local Institution
      • Oshawa、Ontario、カナダ、L1J 2J2
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      • Sarnia、Ontario、カナダ、N7T 6H3
        • Local Institution
      • Scarborough、Ontario、カナダ、M1S 4T7
        • Local Institution
      • St. Catharines、Ontario、カナダ、L2R 7P3
        • Local Institution
      • Stratford、Ontario、カナダ、N5A 2N4
        • Local Institution
      • Waterloo、Ontario、カナダ、N2J 1C4
        • Local Institution
      • Windsor、Ontario、カナダ、N8W 1E6
        • Local Institution
    • Quebec
      • Montreal、Quebec、カナダ、H3G 1A4
        • Local Institution
  • スウェーデン
      • Gothenburg、スウェーデン、416 85
        • Local Institution
      • Stockholm、スウェーデン、182 88
        • Local Institution
  • スペイン
      • Badalona-Barcelone、スペイン、08916
        • Local Institution
      • Barcelona、スペイン、08035
        • Local Institution
      • Barcelona、スペイン、08036
        • Local Institution
      • Barcelona、スペイン、08006
        • Local Institution
      • Barcelona、スペイン、08024
        • Local Institution
  • デンマーク
      • Amager、デンマーク、2300
        • Local Institution
      • Frederiksberg、デンマーク、2000
        • Local Institution
      • Herlev、デンマーク、2730
        • Local Institution
      • Horsholm、デンマーク、2970
        • Local Institution
      • Hvidovre、デンマーク、2650
        • Local Institution
      • Kobenhavn Nv、デンマーク、2400
        • Local Institution
      • Silkeborg、デンマーク、8600
        • Local Institution
  • ドイツ
      • Frankfurt、ドイツ、60528
        • Local Institution
      • Frankfurt / Main、ドイツ、65929
        • Local Institution
      • Rheinfelden、ドイツ、79618
        • Local Institution
  • ノルウェー
      • Gjettum、ノルウェー、1346
        • Local Institution
      • Kongsvinger、ノルウェー、2212
        • Local Institution
      • Lillehammer、ノルウェー、2629
        • Local Institution
      • Tonsberg、ノルウェー、3116
        • Local Institution
      • Tynset、ノルウェー、2500
        • Local Institution
  • ハンガリー
      • Budapest、ハンガリー、1081
        • Local Institution
      • Kecskemet、ハンガリー、6000
        • Local Institution
      • Szeged、ハンガリー、6720
        • Local Institution
      • Szolnok、ハンガリー、5000
        • Local Institution
  • フランス
      • Nice、フランス、06200
        • Local Institution
      • Paris、フランス、75014
        • Local Institution
      • Paris、フランス、75019
        • Local Institution
      • Paris、フランス、75679
        • Local Institution
      • Saint Etienne、フランス、42100
        • Local Institution
      • Saint-Saulve、フランス、59880
        • Local Institution
  • ベルギー
      • Antwerp、ベルギー、2020
        • Local Institution
      • Brasschaat、ベルギー、2930
        • Local Institution
      • Genk、ベルギー、3600
        • Local Institution
      • Hasselt、ベルギー、3500
        • Local Institution
      • Leuven、ベルギー、3000
        • Local Institution
  • ポーランド
      • Gdansk、ポーランド、80-803
        • Local Institution
      • Lodz、ポーランド、91-002
        • Local Institution
      • Szczecin、ポーランド、71-252
        • Local Institution
      • Warszawa、ポーランド、03-242
        • Local Institution
      • Warszawa、ポーランド、02-005
        • Local Institution
      • Wroclaw、ポーランド、50-556
        • Local Institution
  • メキシコ
      • Aguascalientes、メキシコ、20010
        • Local Institution
      • Chihuahua、メキシコ、31020
        • Local Institution
    • Baja California
      • Tijuana、Baja California、メキシコ、22010
        • Local Institution
    • Distrito Federal
      • Mexico City、Distrito Federal、メキシコ、06726
        • Local Institution
      • Mexico City、Distrito Federal、メキシコ、07760
        • Local Institution
    • Jalisco
      • Guadalajara、Jalisco、メキシコ、45235
        • Local Institution
    • Nuevo Leon
      • Monterrey、Nuevo Leon、メキシコ、64460
        • Local Institution
    • Tamaulipas
      • Cd. Madero、Tamaulipas、メキシコ、89240
        • Local Institution
  • ルーマニア
      • Bucharest、ルーマニア、021659
        • Local Institution
      • Cluj Napoca、ルーマニア、400132
        • Local Institution
  • ロシア連邦
      • Chelyabinsk、ロシア連邦、454021
        • Local Institution
      • Kazan、ロシア連邦、420029
        • Local Institution
      • Moscow、ロシア連邦、115522
        • Local Institution
      • Moscow、ロシア連邦、111539
        • Local Institution
      • Moscow、ロシア連邦、117292
        • Local Institution
      • Moscow、ロシア連邦、119415
        • Local Institution
      • Saint Petersburg、ロシア連邦、199106
        • Local Institution
      • Saint Petersburg、ロシア連邦、193312
        • Local Institution
      • Saint Petersburg、ロシア連邦、194354
        • Local Institution
      • Saint Petersburg、ロシア連邦、195427
        • Local Institution
      • Saint Petersburg、ロシア連邦、196247
        • Local Institution
      • Samara、ロシア連邦、443095
        • Local Institution
      • St.Petersburg、ロシア連邦、192242
        • Local Institution
      • Yaroslavl、ロシア連邦、150003
        • Local Institution
  • 中国
    • Beijing
      • Beijing、Beijing、中国、100853
        • Local Institution
      • Beijing、Beijing、中国、100035
        • Local Institution
    • Guangdong
      • Guangzhou、Guangdong、中国、510405
        • Local Institution
    • Shandong
      • Qingdao、Shandong、中国、266003
        • Local Institution
    • Shanghai
      • Shanghai、Shanghai、中国、200025
        • Local Institution
      • Shanghai、Shanghai、中国、200011
        • Local Institution
      • Shanghai、Shanghai、中国、200233
        • Local Institution

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：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)
薬：Apixaban
Oral tablets, 2.5 mg, twice daily, 5weeks
他の名前：
  • BMS-562247
  • エリキュース®
薬：Enoxaparin-matching placebo
Administered as injection
実験的：Enoxaparin, 40 mg QD plus placebo
Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
薬：Enoxaparin
Subcutaneous, 40 mg, once daily, 5 weeks
他の名前：
  • Lovenox®
薬：Apixaban-matching placebo
Administered as oral tablets

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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

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Bristol-Myers Squibb

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研究記録日

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主要日程の研究

研究開始

2007年3月1日

一次修了 (実際)

2009年9月1日

研究の完了 (実際)

2009年9月1日

試験登録日

最初に提出

2007年1月17日

QC基準を満たした最初の提出物

2007年1月17日

最初の投稿 (見積もり)

2007年1月18日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年5月14日

QC基準を満たした最後の更新が送信されました

2014年4月14日

最終確認日

2014年4月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • CV185-035

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