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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008092
Receipt No. R000009514
Scientific Title Drug use survey for LIXIANA
Date of disclosure of the study information 2012/06/04
Last modified on 2015/04/23

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Basic information
Public title Drug use survey for LIXIANA
Acronym Drug use survey for LIXIANA
Scientific Title Drug use survey for LIXIANA
Scientific Title:Acronym Drug use survey for LIXIANA
Region
Japan

Condition
Condition Prevention of venous thromboembolism in patients who have undergone total knee arthroplasty (TKA) or total hip arthroplasty (THA), or hip fracture surgery (HFS)
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate below in relation to LIXIANA treatment

-incidence of unknown adverse drug reactions
-frequency of adverse drug reactions
-overall safety and efficacy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Safety
-frequency of adverse drug reactions
-frequency of severe adverse events
-frequency of bleeding events
Efficacy
-frequency of venous thromboembolism
Special population
-safety and efficacy in patients with hepatic disease, renal disease, and elderly
Key secondary outcomes

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

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who were administrated LIXIANA for the first time after undergoing TKA, THA, and HFS.
Key exclusion criteria None
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Miyuki Arai
Organization DAIICHI SANKYO COMPANY, LIMITED
Division name Pharmacovigilance Department
Zip code
Address 3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo 103-8426, Japan
TEL +81-3-6225-1044
Email arai.miyuki.ue@daiichisankyo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chikada Shuichi
Organization DAIICHI SANKYO COMPANY, LIMITED
Division name Pharmacovigilance Department
Zip code
Address 3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo 103-8426, Japan
TEL +81-3-6225-1044
Homepage URL
Email chikada.shuichi.ic@daiichisankyo.co.jp

Sponsor
Institute DAIICHI SANKYO COMPANY, LIMITED
Institute
Department

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
Email

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
2012 Year 06 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
A total of 2,419 patients were registered. Of 2,406 patients whose case report forms were collected, 2,353 were included in the analysis. Adverse drug reactions occurred in 8.92% (210) of patients. Serious adverse reactions occurred in 0.64% (15) of patients, and all patients recovered or improved. Bleeding events included all bleeding (4.42%, 104 patients), major bleeding (1.10%, 26 patients), clinically relevant non-major bleeding (0.98%, 23 patients), and minor bleeding (2.34%, 55 patients). This survey found no increase of bleeding events in the following group: dosage(15mg or 30mg). All patients recovered or improved. No patients had fatal bleeding events or intracranial bleeding. The incidences of symptomatic VTE was 0.38% (9 patients). Symptomatic VTE included proximal deep vein thrombosis (DVT) (0.08%, 2 patients), distal DVT (0.21%, 5 patients), and pulmonary thromboembolism (0.08%, 2 patients). All patients recovered or improved. Lixiana tablets were shown to be well-tolerated in preventing VTE in patients undergoing lower limb orthopaedic surgery in clinical practice.
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
2011 Year 10 Month 14 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
2013 Year 03 Month 31 Day
Date of closure to data entry
2013 Year 12 Month 26 Day
Date trial data considered complete
2014 Year 02 Month 24 Day
Date analysis concluded
2014 Year 06 Month 26 Day

Other
Other related information prospective study

Management information
Registered date
2012 Year 06 Month 04 Day
Last modified on
2015 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009514

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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