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UMIN-CTR Clinical Trial |
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Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000016387 |
Receipt No. | R000019034 |
Scientific Title | Special Drug Use Surveillance of LIXIANA Tablet - Long-term use in patients with venous thromboembolism - |
Date of disclosure of the study information | 2015/01/30 |
Last modified on | 2019/10/04 |
Basic information | ||
Public title | Special Drug Use Surveillance of LIXIANA Tablet
- Long-term use in patients with venous thromboembolism - |
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Acronym | ETNA-VTE-Japan | |
Scientific Title | Special Drug Use Surveillance of LIXIANA Tablet
- Long-term use in patients with venous thromboembolism - |
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Scientific Title:Acronym | ETNA-VTE-Japan | |
Region |
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Condition | ||||
Condition | Treatment and recurrence prevention of venous thromboembolism [VTE] (deep vein thrombosis [DVT] and pulmonary thromboembolism [PTE]) | |||
Classification by specialty |
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Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | investigate or establish the safety and effectiveness of LIXIANA newly prescribed and administered for 1 year in the clinical setting.
<The following will be the subject of special monitoring:> Incidence of bleeding adverse events |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase IV |
Assessment | |
Primary outcomes | Safety
(1)Occurrence of individual ADRs (2)Occurrence of serious AEs (3)Occurrence of bleeding AEs Efficacy ・Occurrence of recurrent VTE Safety and efficacy in special populations ・Data from the study will be analyzed to investigate the safety and efficacy of LIXIANA in pediatric patients, elderly patients, pregnant/delivering women, patients with hepatic impairment and those with renal impairment. |
Key secondary outcomes |
In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field. |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
Interventions/Control_1 | |
Interventions/Control_2 | |
Interventions/Control_3 | |
Interventions/Control_4 | |
Interventions/Control_5 | |
Interventions/Control_6 | |
Interventions/Control_7 | |
Interventions/Control_8 | |
Interventions/Control_9 | |
Interventions/Control_10 |
In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required. |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients who meet the following requirements when starting to receive LIXIANA (at the time of enrollment for [3]) will be considered for admission to the study:
[1] Patients who have just started to receive LIXIANA for the first time for the treatment and secondary (recurrence) prevention of VTE (DVT and PTE) [2] Patients who are to start treatment with LIXIANA during the period of contract (as per the signed contract between the institution and the sponsor) and during the enrollment period [3] Patients who have given written informed consent to the study |
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Key exclusion criteria | None | |||
Target sample size | 1500 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | DAIICHI SANKYO COMPANY, LIMITED | ||||||
Division name | Post Marketing Study Department | ||||||
Zip code | |||||||
Address | 3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo 103-8426, Japan | ||||||
TEL | +81-3-6225-1044 | ||||||
wada.kento.k8@daiichisankyo.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | DAIICHI SANKYO COMPANY, LIMITED | ||||||
Division name | Post Marketing Study Department | ||||||
Zip code | |||||||
Address | 3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo 103-8426, Japan | ||||||
TEL | +81-3-6225-1044 | ||||||
Homepage URL | |||||||
ouchi.hirohide.bm@daiichisankyo.co.jp |
Sponsor | |
Institute | DAIICHI SANKYO COMPANY, LIMITED |
Institute | |
Department |
Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one. |
Funding Source | |
Organization | DAIICHI SANKYO COMPANY, LIMITED |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization | JAPAN |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | N.A. |
Publication of results | Partially published |
Result | |
URL related to results and publications | https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-18-1362/_article/-char/en |
Number of participants that the trial has enrolled | |
Results | The results confirm no major concerns about the safety and effectiveness of edoxaban in Japanese patients with VTE in the first 3 months of treatment.
Safety and effectiveness profiles of edoxaban in patients receiving the low dose (30 mg/day), generally administered to patients with high bleeding risk, were similar to those of the standard dose (60 mg/day). |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
Other | |
Other related information | 1.Demographic
2.Extent of exposure to LIXIANA, medical treatments for VTE and other medications 3.Efficacy: Occurrence of recurrent VTE 4.Safety: Adverse events (including bleeding AEs) |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019034 |