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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04865406




Registration number
NCT04865406
Ethics application status
Date submitted
26/04/2021
Date registered
29/04/2021

Titles & IDs
Public title
Forxiga HF General Drug Use-Results Study
Scientific title
Forxiga Tablets General Drug Use-Results Study in Patients With HF
Secondary ID [1] 0 0
D1699C00017
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
frequency of adverse drug reactions (ADRs)
Timepoint [1] 0 0
1 year

Eligibility
Key inclusion criteria
* Patients aged more than 15 years
* Patients who have been prescribed Forxiga for the first time
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with a history of hypersensitivity to any ingredients of this drug.
* Patients with severe ketosis, diabetic coma or precoma
* Patients with severe infections, before or after a surgery, or with serious trauma

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/08/2024
Sample size
Target
Accrual to date
Final
1221
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Japan
State/province [1] 0 0
Aichi
Country [2] 0 0
Japan
State/province [2] 0 0
Akita
Country [3] 0 0
Japan
State/province [3] 0 0
Aomori
Country [4] 0 0
Japan
State/province [4] 0 0
Chiba
Country [5] 0 0
Japan
State/province [5] 0 0
Ehime
Country [6] 0 0
Japan
State/province [6] 0 0
Fukui
Country [7] 0 0
Japan
State/province [7] 0 0
Fukuoka
Country [8] 0 0
Japan
State/province [8] 0 0
Fukushima
Country [9] 0 0
Japan
State/province [9] 0 0
Gifu
Country [10] 0 0
Japan
State/province [10] 0 0
Gunma
Country [11] 0 0
Japan
State/province [11] 0 0
Hiroshima
Country [12] 0 0
Japan
State/province [12] 0 0
Hokkaido
Country [13] 0 0
Japan
State/province [13] 0 0
Hyogo
Country [14] 0 0
Japan
State/province [14] 0 0
Ibaraki
Country [15] 0 0
Japan
State/province [15] 0 0
Ishikawa
Country [16] 0 0
Japan
State/province [16] 0 0
Iwate
Country [17] 0 0
Japan
State/province [17] 0 0
Kagawa
Country [18] 0 0
Japan
State/province [18] 0 0
Kagoshima
Country [19] 0 0
Japan
State/province [19] 0 0
Kanagawa
Country [20] 0 0
Japan
State/province [20] 0 0
Kochi
Country [21] 0 0
Japan
State/province [21] 0 0
Kumamoto
Country [22] 0 0
Japan
State/province [22] 0 0
Kyoto
Country [23] 0 0
Japan
State/province [23] 0 0
Mie
Country [24] 0 0
Japan
State/province [24] 0 0
Miyagi
Country [25] 0 0
Japan
State/province [25] 0 0
Miyazaki
Country [26] 0 0
Japan
State/province [26] 0 0
Nagano
Country [27] 0 0
Japan
State/province [27] 0 0
Nagasaki
Country [28] 0 0
Japan
State/province [28] 0 0
Nara
Country [29] 0 0
Japan
State/province [29] 0 0
Oita
Country [30] 0 0
Japan
State/province [30] 0 0
Okayama
Country [31] 0 0
Japan
State/province [31] 0 0
Okinawa
Country [32] 0 0
Japan
State/province [32] 0 0
Osaka
Country [33] 0 0
Japan
State/province [33] 0 0
Saga
Country [34] 0 0
Japan
State/province [34] 0 0
Saitama
Country [35] 0 0
Japan
State/province [35] 0 0
Shiga
Country [36] 0 0
Japan
State/province [36] 0 0
Shimane
Country [37] 0 0
Japan
State/province [37] 0 0
Shizuoka
Country [38] 0 0
Japan
State/province [38] 0 0
Tochigi
Country [39] 0 0
Japan
State/province [39] 0 0
Tokushima
Country [40] 0 0
Japan
State/province [40] 0 0
Tokyo
Country [41] 0 0
Japan
State/province [41] 0 0
Toyama
Country [42] 0 0
Japan
State/province [42] 0 0
Wakayama
Country [43] 0 0
Japan
State/province [43] 0 0
Yamagata
Country [44] 0 0
Japan
State/province [44] 0 0
Yamaguchi
Country [45] 0 0
Japan
State/province [45] 0 0
Yamanashi

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04865406