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Clinical Trial Details

Trial ID: L1120
Source ID: NCT04764097
Associated Drug: Dapagliflozin
Title: Dapagliflozin Effect on Cardiovascular Outcomes in Haemodialysis for End Stage Renal Disease
Acronym: DECODED
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Cardiovascular Diseases|End Stage Renal Disease
Interventions: DRUG: Dapagliflozin|DRUG: Placebo
Outcome Measures: Primary: Subjects included in the composite endpoint of cardiovascular death, myocardial infarction or ischemic stroke (time to first or recurrent event)., Data will be derived from 3 monthly telephone follow-up and 6monthly physical site visits and events are documented in eCRF, Up to 3 years | Secondary: Subjects included in the composite endpoint of all-cause death or hospitalization for unstable angina (time to first or recurrent event)., Data will be derived from 3 monthly telephone follow-up and 6monthly physical site visits and events are documented in eCRF, Up to 3 years | Other: Safety and tolerability will be assessed from overall adverse events, serious adverse events, adverse events of special interest, The assessment will include an evaluation of the incidence of adjudicated hyperkalemia, diabetic ketoacidosis, thromboembolic event, genital infections, bone fractures,amputation, liver injury etc.Data will be derived from 3 monthly telephone follow-up and 6monthly physical site visits and events are documented in eCRF, Up to 3 years
Sponsor/Collaborators: Sponsor: Tan Tock Seng Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2|PHASE3
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2021-06
Completion Date: 2026-06
Results First Posted:
Last Update Posted: 2021-10-21
Locations:
URL: https://clinicaltrials.gov/show/NCT04764097