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Clinical Trial Details

Trial ID: L4604
Source ID: NCT01944618
Associated Drug: Forxiga
Title: forREAL: FORXIGA PRESCRIPTION EVENT MONITORING PROGRAM (PEMP)
Acronym: forREAL
Status: TERMINATED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Forxiga
Outcome Measures: Primary: Incidence rates of adverse events, specifically genital infections, urinary tract infections, increased haematocrit, renal impairment, hepatic impairment, bone fractures and cancers, in particular breast, bladder, and prostate cancers, Assessed in patients with Type 2 diabetes who are treated with Forxiga in routine Australian clinical practice, Up to 6 months|Any early adverse effects as a result of drug interactions in patients with Type 2 diabetes who are treated with Forxiga in routine Australian clinical practice, Up to 6 months|Incidence rates of spontaneously reported hypoglycaemia in patients with Type 2 diabetes who are treated with Forxiga in routine Australian clinical practice, Up to 6 months | Secondary: Rate of prescribing of Forxiga after its introduction to routine Australian clinical practice, Upto 6 months|Indication for prescription of Forxiga in routine Australian clinical practice, Upto 6 months|Change in efficacy and safety variables after treatment with Forxiga for at least 3 months, Including: * HbA1c * Weight * Systolic blood pressure * Diastolic blood pressure * Heart rate * Serum creatinine * Estimated glomerular filtration rate * Liver function tests \[Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), or bilirubin\], Baseline and 3 months|Subgroup analyses may be conducted for selected safety parameters, Subgroups to be evaluated will include gender, age, diabetes duration, concomitant medication, past medical history, and measured laboratory variables (if available), Upto 6 months
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Monash University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 5000
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2013-10
Completion Date: 2015-10
Results First Posted:
Last Update Posted: 2016-09-13
Locations: Local Institution, Clayton, Victoria, VIC 3168, Australia
URL: https://clinicaltrials.gov/show/NCT01944618