GLORIA-AF Registry Program - Second and Third Phases
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ClinicalTrials.gov Identifier: NCT01468701 |
Recruitment Status
:
Active, not recruiting
First Posted
: November 9, 2011
Last Update Posted
: March 29, 2018
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
Tracking Information | ||||
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First Submitted Date | October 28, 2011 | |||
First Posted Date | November 9, 2011 | |||
Last Update Posted Date | March 29, 2018 | |||
Actual Study Start Date | November 7, 2011 | |||
Estimated Primary Completion Date | January 14, 2020 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
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Original Primary Outcome Measures |
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Change History | Complete list of historical versions of study NCT01468701 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | GLORIA-AF Registry Program - Second and Third Phases | |||
Official Title | GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients With Atrial Fibrillation (Phase II/III) | |||
Brief Summary | In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. For administrative purposes the study is divided into two protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European Economic Area) countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in both protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129. | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | patients with non-valvular AF | |||
Condition |
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Intervention | Not Provided | |||
Study Groups/Cohorts | Not Provided | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Active, not recruiting | |||
Estimated Enrollment |
19000 | |||
Original Estimated Enrollment |
30000 | |||
Estimated Study Completion Date | January 14, 2020 | |||
Estimated Primary Completion Date | January 14, 2020 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion criteria:
Other inclusion criteria apply. Exclusion criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Argentina, Brazil, Canada, Chile, China, Colombia, Ecuador, Hong Kong, Japan, Korea, Republic of, Lebanon, Mexico, Peru, Russian Federation, Saudi Arabia, Singapore, South Africa, Taiwan, United Arab Emirates, United States, Venezuela | |||
Removed Location Countries | Croatia, Puerto Rico, Turkey | |||
Administrative Information | ||||
NCT Number | NCT01468701 | |||
Other Study ID Numbers | 1160.129 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Boehringer Ingelheim | |||
Study Sponsor | Boehringer Ingelheim | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Boehringer Ingelheim | |||
Verification Date | March 2018 |