The Treatment of Acute Pulmonary Thromboembolism (PE) of GSK576428 (Fondaparinux Sodium) in Japanese Patients

NCT00981409 | Completed Phase 3 Results

• 1 other identifier: 106206
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 27

Brief Summary

The primary objective is to evaluate the efficacy (as measured by the rate of recurrent symptomatic Venous Thromboembolism \[VTE\] (i.e., Pulmonary thromboembolism \[PE\] and Deep Vein Thrombosis \[DVT\])) and safety of GSK576428 as the initial treatment in subjects with acute PE in an open-label design.

Conditions

Embolism, Pulmonary

Keywords

Fondaparinux sodium; contrast-enhanced MDCT; Deep Vein Thrombosis; Pulmonary thromboembolism

Outcome Measures

Primary Outcomes (1)

• The Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)

  VTE (pulmonary thromboembolism \[PE\] and/or deep vein thromboembolism \[DVT\]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).

  From Day 1 to Day 90 (±7 days)

Secondary Outcomes (4)

• The Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic Venous Thromboembolism (VTE) (by Type)

  From Day 1 to Day 90 (±7 days)

• The Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse

  Baseline, Days 5-10 (the day when the medication [FPX or UFH] was finished /discontinued) (+/-1)

• Total Perfusion Score at Baseline and Mean Change From Baseline at Days 5-10

  Baseline, Days 5-10 (the day when the medication [FPX or UFH] was finished /discontinued) (+/-1)

• The Percentage of Participants With a Bleeding Event

  FPX or UFH treatment period (Days 5-10, on average)

Study Arms (2)

Fondaparinux

EXPERIMENTAL

Drug: Fondaparinux sodium

unfractionated heparin

OTHER

Drug: unfractionated heparin (UFH)

Interventions

Fondaparinux sodium DRUG

The dose of Fondaparinux will be determined based on a subject's body weight (\<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; \>100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection.

Also known as: GSK576428

Fondaparinux

unfractionated heparin (UFH) DRUG

UFH therapy will be started on Day 1 while adjusting activated partial thromboplastin time (aPTT) to maintain aPTT 1.5 to 2.5 times control.

unfractionated heparin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with a confirmed diagnosis (by Multi detector-row CT \[MDCT\]) of acute symptomatic PE who are hemodynamically stable (i.e., the condition where anticoagulant therapy alone are indicated) (the time from onset should be no longer than 5 days, and subjects with or without symptomatic DVT are eligible)
• Age: \>=20 years
• Gender: No restriction Female subjects must either be of non-childbearing potential (post-menopausal \>1 year, hysterectomy, or sterilization), or of childbearing potential, has a negative pregnancy test at screening, and agree to use contraception throughout the study period.
• Hospitalization status: Subjects who are able to stay at the hospital at least during the initial treatment period.
• Written informed consent from the subject him/herself or his/her legally acceptable representative. Written informed consent from the subject's legally acceptable representative must be obtained if the subject is incapable of giving consent.

You may not qualify if:

• Shock or hemodynamic instability\*.
• \*: Defined as shock or decreased blood pressure (systolic blood pressure \<90 mmHg or \>=40 mmHg) lasting for at least 15 minutes and does not represent hemodynamically unstable conditions due to newly emergent arrhythmia, dehydration or sepsis.
• Right cardiac function failure detected by echocardiography at screening.
• Requirement for surgical thrombectomy, catheter intervention and thrombolytic therapy for the current PE.
• Subjects (for example, with free-floating thrombus in the femoral vein or ilium by MDCT at screening) for whom insertion of inferior vena cava filter is indicated or subjects in whom inferior vena cava filter is present.
• Prior to entry into the study, therapeutic dosage of anticoagulants for more than 24 hours to treat the current episode.
• Active, clinically significant bleeding
• Thrombocytopenia (platelet count \<10×10⁴/µL at screening)
• Concurrent conditions with bleeding risk (e.g., ulcer of the gastrointestinal tract, diverticulitis of the gastrointestinal tract, colitis, acute bacterial endocarditis, severe hypertension\*, or severe diabetes) or bleeding tendency.
• \*: systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg
• Severe hepatic disorder
• Known hypersensitivity to heparin, low-molecular-weight heparin (LMWH) or warfarin
• Previous history of cerebral hemorrhage
• Brain, spinal, or ophthalmological surgery within 3 months prior to entry into this study
• Previous history of Heparin-induced thrombocytopenia

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (27)

GSK Investigational Site

Aichi, 440-8510, Japan

Location

GSK Investigational Site

Chiba, 260-8677, Japan

Location

GSK Investigational Site

Fukuoka, 802-8555, Japan

Location

GSK Investigational Site

Gunma, 370-0829, Japan

Location

GSK Investigational Site

Gunma, 371-8511, Japan

Location

GSK Investigational Site

Hokkaido, 060-8543, Japan

Location

GSK Investigational Site

Hokkaido, 060-8648, Japan

Location

GSK Investigational Site

Hyōgo, 654-0155, Japan

Location

GSK Investigational Site

Ibaraki, 305-8576, Japan

Location

GSK Investigational Site

Ibaraki, 311-3193, Japan

Location

GSK Investigational Site

Kagoshima, 892-0853, Japan

Location

GSK Investigational Site

Kumamoto, 860-0008, Japan

Location

GSK Investigational Site

Kumamoto, 860-8556, Japan

Location

GSK Investigational Site

Mie, 514-8507, Japan

Location

GSK Investigational Site

Nagano, 390-8621, Japan

Location

GSK Investigational Site

Nagasaki, 859-3615, Japan

Location

GSK Investigational Site

Niigata, 951-8520, Japan

Location

GSK Investigational Site

Okayama, 701-1192, Japan

Location

GSK Investigational Site

Osaka, 530-8480, Japan

Location

GSK Investigational Site

Osaka, 540-0006, Japan

Location

GSK Investigational Site

Osaka, 565-8565, Japan

Location

GSK Investigational Site

Saitama, 351-0102, Japan

Location

GSK Investigational Site

Tokyo, 104-8560, Japan

Location

GSK Investigational Site

Tokyo, 113-8603, Japan

Location

GSK Investigational Site

Tokyo, 113-8655, Japan

Location

GSK Investigational Site

Tokyo, 160-8582, Japan

Location

GSK Investigational Site

Tokyo, 180-8610, Japan

Location

Related Publications (1)

• Nakamura M, Okano Y, Minamiguchi H, Munemasa M, Sonoda M, Yamada N, Hanzawa K, Aoyagi N, Tsujimoto H, Sarai N, Nakajima H, Kunieda T. Multidetector-row computed tomography-based clinical assessment of fondaparinux for treatment of acute pulmonary embolism and acute deep vein thrombosis in Japanese patients. Circ J. 2011;75(6):1424-32. doi: 10.1253/circj.cj-10-1036. Epub 2011 Apr 22.

  PMID: 21512258 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Pulmonary Embolism; Venous Thrombosis

Interventions

Fondaparinux; Heparin

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates; Glycosaminoglycans

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2009
• First Posted: September 22, 2009
• Study Start: July 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 16, 2016
• Results First Posted: December 10, 2009

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

JP (27)