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Embolism, PulmonaryPhase 3NCT00981409

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

A Phase 3 study testing Fondaparinux sodium and unfractionated heparin (UFH) in people with Embolism, Pulmonary, run by GlaxoSmithKline at 27 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Embolism, Pulmonary
What is being tested?
Fondaparinux sodium and unfractionated heparin (UFH)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
27 sitesJapan
Study dates
Jul 2007to Dec 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 27Show fewer
  • 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
  • Patients for whom anticoagulant therapy is contraindicated or who cannot be taken off anticoagulant therapy due to coexistent condition (e.g. prosthetic heart valve implant).
  • Severe renal disorder (serum creatinine >2.0 mg/dL [180 µmol/L] at screening) in a well hydrated subject
  • Documented hypersensitivity to contrast media
  • Use of any contraindicated drug that cannot be combined with the injection of contrast medium [e.g., antihyperglycemic metformin hydrochloride (Glycoran®, Melbin®)]
  • Participation in any other therapeutic drug study or a clinical study within 6 months prior to entry into this study
  • Previous participation in a study of GSK576428
  • Drug or alcohol abuse
  • Systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg
  • Recent surgery within 3 days prior to entry into the study
  • Life expectancy <3 months
  • Pregnant women, nursing mothers, women who may be pregnant, or women contemplating pregnancy during the study period
  • Others whom the investigator or subinvestigator considers not eligible for the study

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

Japan27 sites

  • GSK Investigational Site

    Aichi, 440-8510

  • GSK Investigational Site

    Chiba, 260-8677

  • GSK Investigational Site

    Fukuoka, 802-8555

  • GSK Investigational Site

    Gunma, 370-0829

  • GSK Investigational Site

    Gunma, 371-8511

  • GSK Investigational Site

    Hokkaido, 060-8543

  • GSK Investigational Site

    Hokkaido, 060-8648

  • GSK Investigational Site

    Hyōgo, 654-0155

  • GSK Investigational Site

    Ibaraki, 305-8576

  • GSK Investigational Site

    Ibaraki, 311-3193

  • GSK Investigational Site

    Kagoshima, 892-0853

  • GSK Investigational Site

    Kumamoto, 860-0008

  • GSK Investigational Site

    Kumamoto, 860-8556

  • GSK Investigational Site

    Mie, 514-8507

  • GSK Investigational Site

    Nagano, 390-8621

  • GSK Investigational Site

    Nagasaki, 859-3615

  • GSK Investigational Site

    Niigata, 951-8520

  • GSK Investigational Site

    Okayama, 701-1192

  • GSK Investigational Site

    Osaka, 530-8480

  • GSK Investigational Site

    Osaka, 540-0006

  • GSK Investigational Site

    Osaka, 565-8565

  • GSK Investigational Site

    Saitama, 351-0102

  • GSK Investigational Site

    Tokyo, 104-8560

  • GSK Investigational Site

    Tokyo, 113-8603

  • GSK Investigational Site

    Tokyo, 113-8655

  • GSK Investigational Site

    Tokyo, 160-8582

  • GSK Investigational Site

    Tokyo, 180-8610

Other trials in Japan

About this study

Official title: Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in the Treatment of Acute Pulmonary Thromboembolism (PE)

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.

Being tested
Fondaparinux sodium, unfractionated heparin (UFH)
Keywords
Fondaparinux sodium, contrast-enhanced MDCT, Deep Vein Thrombosis, Pulmonary thromboembolism
Medical subject headings
Pulmonary Embolism, Venous Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fondaparinux sodiumDrug

    Also called GSK576428

    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.

  • 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.

Study groups in NCT00981409
Study groupRoleWhat they receive
FondaparinuxExperimentalNot described
Receives: Drug: Fondaparinux sodium
unfractionated heparinOtherNot described
Receives: Drug: unfractionated heparin (UFH)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: From Day 1 to Day 90 (±7 days)

Secondary outcomes (4)

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

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

    Measured: From Day 1 to Day 90 (±7 days)

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

    "Improved," "No change," or "Worse" was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). Each category is adjudicated by comparison with the perfusion score at baseline by the CIACE.

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

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

    The perfusion score (0: no perfusion; 0.25, 0.5, 0.75, 1: normal) in each of the six lobes of the lung was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). Total perfusion score (r) was calculated as: r = (0.25 x right lower lobe) + (0.12 x right middle lobe) + (0.18 x right upper lobe) + (0.20 x left lower lobe) + (0.12 x lingula) + (0.13 x left upper lobe).

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

  4. The Percentage of Participants With a Bleeding Event

    Bleeding events (major bleeding [clinically overt bleeding with: fatality, location in critical organ, a fall in hemoglobin >=2 g/dL, or a transfusion >=2 units], minor bleeding [clinically overt bleeding and not adjudicated as major bleeding]) were adjudicated blindly by the Central Independent Adjudication Committee of Safety (CIACS).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2009 (estimated)
  2. Study startJul 2007
  3. Primary completionDec 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00981409
Sponsor's protocol ID
106206
Status last verified
Nov 2016
First submitted
3 Sep 2009
Last updated
16 Dec 2016
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • 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.

    PubMed 21512258

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fondaparinux sodium and unfractionated heparin (UFH) in people with Embolism, Pulmonary, run by GlaxoSmithKline at 27 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) (time frame: From Day 1 to Day 90 (±7 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00981409, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2016.

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