An observational study in Hypertension, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Brigham and Women's Hospital · Observational
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.
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 63,744 is above the median of 210 across 1,359 observational studies indexed under Hypertension.
Browse Hypertension studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
This study will involve a new user, parallel group, cohort study design comparing telmisartan to ramipril. The patients will be required to have continuous enrollment during baseline period of 180 days before initiation of telmisartan or the comparator drug (cohort entry date). Follow-up for the outcome, begins the day after drug initiation. As in the trial, patients are allowed to take other antihypertensive medications during the study.
Please see: https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.
Eligible cohort entry dates: Market availability of telmistartan in the U.S. started on November 10, 1998, however, the Marketscan and Optum data are available at BWH only from Jan 1, 2003 and Jan 1, 2004, respectively. For Marketscan: Jan 1, 2003 -Dec 2017 (end of data availability). For Optum: Jan 1, 2004-June 30, 2019 (end of data availability).
Inclusion Criteria:
Individuals 55 years of age with 1 of the following:
Coronary artery disease
Peripheral artery disease
Cerebrovascular disease
Diabetus mellitus
Exclusion Criteria:
Medication use
Cardiovascular disease (HF)
Other conditions
Reference group
Drug: Ramipril
Exposure group
Drug: Telmisartan
Ramipril dispensing claim is used as the reference
Telmisartan dispensing claim is used as the exposure
Relative hazard of composite outcome of Heart Failure, Stroke, MI, and Mortality
Relative hazard of composite outcome of Heart Failure, Stroke, MI, and Mortality - Please refer to uploaded protocol for full definition due to size limitations.
Time frame: [Time Frame: Through study completion (a median of ***118-123**** days)]
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Brigham and Women's Hospital