Study of Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension
Condition(s) studied
Investigational drug(s) / intervention(s)
Tonlamarsen: Tonlamarsen will be administered subcutaneously (under the skin) every 4 weeks during the randomized part of the study
Placebo: Placebo will be administered subcutaneously (under the skin) every 4 weeks during the randomized part of the study
Study summary
The purpose of this study is to evaluate the blood pressure-lowering effect of tonlamarsen in adult participants who were recently hospitalized and concurrently experienced an episode of acute severe hypertension.
Eligibility
Primary outcome measure(s)
- Part A: To assess variability in clinical and biomarker measures to inform Part B sample-size estimation and study-design assumptions — Baseline through Week 12
* Change from baseline in plasma angiotensinogen (AGT) levels and systolic blood pressure * Variability in plasma AGT levels and systolic blood pressure - Part B: To assess the pharmacodynamic (PD) effect of tonlamarsen on plasma AGT levels — Week 4
Percent change in plasma AGT levels from Baseline to Week 4
Trial sites (13)
| Facility | City | Region | Status |
|---|---|---|---|
| Western Nephrology and Metabolic Bone Disease, PC - Arvada | Arvada | Colorado | Recruiting |
| Homestead Associates in Research | Homestead | Florida | Recruiting |
| Progressive Medical Research | Port Orange | Florida | Recruiting |
| Eagle Clinical Research | Chicago | Illinois | Recruiting |
| Henry Ford Hospital | Detroit | Michigan | Recruiting |
| Richmond University Medical Center (RUMC) | Staten Island | New York | Active Not Recruiting |
| Research Innovations, LLC | Beavercreek | Ohio | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| OnSite Clinical Solutions, LLC | Fort Mill | South Carolina | Recruiting |
| Chattanooga Research & Medicine CHARM | Chattanooga | Tennessee | Recruiting |
| Laguna Clinical Research Associates | Laredo | Texas | Recruiting |
| Tapia Internal Medicine Clinic | Paris | Texas | Recruiting |
| Baylor Scott and White Research Institute - Temple | Temple | Texas | Recruiting |
More Kardigan, Inc. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07511361 on ClinicalTrials.gov ↗ ← All trials in the USA