- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00320424
Hip Fracture Study of GSK576428 (Fondaparinux Sodium)
30. august 2018 oppdatert av: GlaxoSmithKline
Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism After Hip Fracture Surgery
This study is requested by PMDA to confirm the efficacy and the safety for HFS.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
48
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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- GSK Investigational Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Patients undergoing hip fracture surgery within 10 days following the time of fracture of the hip (proximal femur) (or following the time of fracture estimated from trauma).
Exclusion Criteria:
- Active, clinically significant bleeding (excluding drainage).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Rate of Major Bleeding During Treatment Period
Tidsramme: From the first study drug injection up to Day 17
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Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100.
Signs and symptoms suggestive of venous thromboembolic events (VTE) included, but were not limited to lower extremity deep vein thrombosis (DVT): erythema, warmth, pain, swelling, tenderness and pulmonary embolism (PE): pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia.
Intended treatment period started 24±2 hours after surgical closure.
Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17).
These events were adjudicated by the Central Independent Adjudication Committee of Efficacy (CIACE).
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From the first study drug injection up to Day 17
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Rate of PE During Treatment Period
Tidsramme: Up to Day 17
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Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100.
Signs and symptoms suggestive of VTE included, but were not limited to lower extremity PE: pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia.
Intended treatment period started 24±2 hours after surgical closure.
Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17).
These events were adjudicated by the CIACE.
It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.
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Up to Day 17
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Rate of DVT During Treatment Period
Tidsramme: Up to Day 17
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Rate (%) was defined as number of events divided by the number of patients evaluated multiplied by 100.
Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness.
Intended treatment period started 24±2 hours after surgical closure.
Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17).
These events were adjudicated by the CIACE.
It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.
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Up to Day 17
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Rate of Proximal DVT During Treatment Period
Tidsramme: Up to Day 17
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Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100.
Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness.
Intended treatment period started 24±2 hours after surgical closure.
Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17).
These events were adjudicated by the CIACE.
It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.
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Up to Day 17
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Rate of Distal Only DVT During Treatment Period
Tidsramme: Up to Day 17
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Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100.
Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness.
Intended treatment period started 24±2 hours after surgical closure.
Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17).
These events were adjudicated by the CIACE.
It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.
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Up to Day 17
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Number of Participants With Major Bleeding During Treatment Period
Tidsramme: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
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Major bleeding events were defined as clinically unusual bleeding meeting any of the following criteria: fatal bleeding, bleeding including retroperitoneal and intracranial bleeding or bleeding into a critical organ (eye, adrenal gland, pericardium, spine), reoperation due to bleeding/hematoma at the operative site, bleeding leading to a hemoglobin (Hb) fall >=2 grams per deciliter (g/dL, 1.6 millimoles per liter [mmol/L]) within 48 hour of the bleed, bleeding that required a transfusion of red blood cell or whole blood derived from >=900 millilters (mL) of whole blood within 48 hours of the bleed (excluding the autologous transfusion except for the treatment of bleeding adverse event (AE) and bleeding leading to the bleeding index (BI) >=2.
Major bleeding events were adjudicated by the Central Independent Adjudication Committee of Safety (CIACS).
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From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
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Number of Participants With Minor Bleeding and Any Bleeding (Major and/or Minor Bleeding)
Tidsramme: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
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Minor bleeding and any bleeding (major and/or minor bleeding) events were adjudicated by the CIACS.
Minor bleeding was defined as clinically overt bleeding not meeting the criteria for major bleeding and considered more than expected in the clinical context.
Any bleeding (major and/or minor bleeding) could be recorded may be major and/or minor.
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From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
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Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death
Tidsramme: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
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An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use.
The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
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From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
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Number of Transfused Participants
Tidsramme: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
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Blood product transfusions consisted of packed red blood cells or fresh frozen plasma or both.
This was done between Day 2 and 2 calendar days after the last injection.
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From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
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Summary of Units Transfused
Tidsramme: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
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Blood product transfusions consisted of packed red blood cells or fresh frozen plasma or both.
This was done between Day 2 and 2 calendar days after the last injection.
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From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
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Rate of Symptomatic DVT
Tidsramme: Up to Day 17
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Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100.
Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness.
Intended treatment period started 24±2 hours after surgical closure.
Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17).
These events were adjudicated by the CIACE.
It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.
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Up to Day 17
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
16. februar 2006
Primær fullføring (Faktiske)
26. oktober 2006
Studiet fullført (Faktiske)
26. oktober 2006
Datoer for studieregistrering
Først innsendt
1. mai 2006
Først innsendt som oppfylte QC-kriteriene
1. mai 2006
Først lagt ut (Anslag)
3. mai 2006
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. september 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. august 2018
Sist bekreftet
1. august 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Brudd, bein
- Sår og skader
- Beinskader
- Embolisme og trombose
- Femoral frakturer
- Hofteskader
- Hoftebrudd
- Tromboemboli
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Fibrinolytiske midler
- Fibrinmodulerende midler
- Proteasehemmere
- Faktor Xa-hemmere
- Antitrombiner
- Serinproteinasehemmere
- Antikoagulanter
- Fondaparinux
- PENTA
Andre studie-ID-numre
- AR3106335
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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