NCT04354376|CompletedFDA Drug
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Sponsor study identifier
observational
40,048
1 country
1
Study Start
September 22, 2017
Actual (reported)Primary Completion
February 8, 2021
Actual (reported)Study Completion
February 8, 2021
Actual (reported)Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 8, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 22, 2017
Actual (reported)April 17, 2020
Actual (reported)April 21, 2020
Actual (reported)February 8, 2021
Actual (reported)February 8, 2021
Actual (reported)Relative hazard of composite outcome of Congestive Heart Failure, Stroke, MI, and Mortality
Relative hazard of composite outcome of Congestive Heart Failure, Stroke, MI, and Mortality - Please refer to uploaded protocol for full definition due to size limitations.
Through study completion (a median of ***118-123**** days)
Reference group
Exposure group
Loop diuretics, thiazides, or dihydropyridines dispensing claim is used as the reference
Telmisartan dispensing claim is used as the exposure
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
This study will involve a new user, parallel group, propensity score-matched, retrospective cohort study design comparing telmisartan to other antihypertensives, including loop diuretics, thiazides, and dihydropyridines. Although the trial compared telmisartan with placebo added to usual care, the investigators selected an active comparator for this study because non-user comparator groups are known to often lead to confounding by indication and biased treatment effect estimates. This group of other antihypertensives were selected as the primary comparator because intolerance to ACEi was a primary inclusion criteria for the trial. Therefore, patients in both arms were on a mix of non-ACEi and non-ARB antihypertensives as background therapy.
Brigham And Women's Hospital
Boston, Massachusetts, 02120, United States
Shirley Wang, PhD, ScM
Brigham and Women's Hospital
40,048 participants (actual enrollment reported by the registry).
First Submitted
April 17, 2020
First Posted
April 21, 2020
Study Start
September 22, 2017
Actual (reported)Micardis®. Observational Study in Patients With Essential Hypertension
Contact the study team to confirm eligibility.
Primary Completion
February 8, 2021
Actual (reported)Study Completion
February 8, 2021
Actual (reported)Last Updated
July 27, 2023
Record last verified: 2023-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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