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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01632878
Other study ID # P13-764
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2012
Est. completion date December 2014

Study information

Verified date April 2016
Source Viatris Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The OPTIMISE study is a prospective, multi-center, multi-national, structured data collection initiative, first compiling data on the current treatment of post myocardial infarction patients (screening-log) and then, prospectively evaluating only those patients being prescribed Omacor as part of their standard secondary prevention treatment. The aim is to observe the Omacor cohort of patients for a period of 12 months, collecting long term observational data as clinical and patient-reported outcomes, especially, but not exclusively, recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive Heart Failure (CHF). No predefined additional visits, medical tests, labs, procedures or interventions will be mandated. Only results from routinely performed tests, labs, procedures and/or interventions will be collected if available.


Recruitment information / eligibility

Status Completed
Enrollment 1531
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria - Male and female patients, from the screening-log, having been prescribed prior to their inclusion in the study Omega-3-fatty-acid ethyl esters (Omacor) as adjuvant treatment in secondary prevention after their myocardial infarction, in addition to standard therapy [e.g. statins, antiplatelet medicinal products, beta blockers, Angiotensine Converting Enzyme (ACE) inhibitors/Angiotensine II Receptor Blockers (ARBs), etc]. Exclusion Criteria - Omega-3-fatty-acid ethyl esters (Omacor) approved contra-indication as per the labeling information in participating countries

Study Design


Locations

Country Name City State
Bulgaria Site Reference ID/Investigator# 81558 Plovdiv

Sponsors (3)

Lead Sponsor Collaborator
Mylan Inc. EBC - Evidence Based Communication, inVentiv Health Germany GmbH

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Occurrences of Cardio-vascular Events Such as: recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive Heart Failure (CHF) 12 months
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