Post-Marketing Surveillance of Prazaxa® on the Long-term Use in Patients With Nonvalvular Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT01491178|
Recruitment Status : Completed
First Posted : December 13, 2011
Results First Posted : January 30, 2018
Last Update Posted : January 30, 2018
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation||Drug: Prazaxa|
|Study Type :||Observational|
|Actual Enrollment :||6772 participants|
|Official Title:||Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in Patients With Nonvalvular Atrial Fibrillation|
|Actual Study Start Date :||December 12, 2011|
|Actual Primary Completion Date :||August 2, 2016|
|Actual Study Completion Date :||August 2, 2016|
|Patients with NVAF||
- Frequency (Percentage) of Participants With Adverse Drug Reactions [ Time Frame: Up to 104 weeks from first administration of study drug ]Percentage of participants with adverse drug reactions (ADRs) is presented. An ADR is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Prazaxa® Capsules either as "Related", "Probably related", or "Cannot be denied".
- Incidences of Stroke and Systemic Embolism (SEE) [ Time Frame: Up to 104 weeks from first administration of study drug ]Incidence rate of Stroke and SEE (number of patients per 100 patient year) with 95% confidence interval (CI) is reported. Stroke and SEE were recorded as adverse events (AEs) of special interest. Exact Poisson confidence intervals are presented for incidence rate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491178
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|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|