UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000008092
Receipt number	R000009514
Scientific Title	Drug use survey for LIXIANA
Date of disclosure of the study information	2012/06/04
Last modified on	2015/04/23 10:49:53

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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

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

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 or person

Institute

DAIICHI SANKYO COMPANY, LIMITED

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.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