HypertensionAcute Severe HypertensionHypertensive EmergencyHypertensive Urgency
Investigational drug(s) / intervention(s)
TonlamarsenPlacebo
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria:
* Age 18 or older, body weight ≥ 50 kg with BMI ≤45.0 kg/m2
* Ready for discharge or recently discharged from the hospital to home (within the past 7 days) during which evaluation and/or treatment of acute severe hypertension (documented SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg) occurred, as measured by a healthcare provider (HCP) within the 24 hours preceding hospitalization or during the initial 24 hours of hospitalization
* At Screening and Randomization visit, average resting office systolic blood pressure ≥ 145 mmHg
* Presence of established cardiovascular or renal disease
Key Exclusion Criteria:
* Has known history of secondary hypertension
* Any malignancy requiring treatment within 5 years (except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated)
* Has abnormal thyroid function with clinical significance
* Recent hospitalization for stroke, myocardial infarction or coronary revascularization within 30 days prior to screening
* History of and/or obvious clinical signs or symptoms of cirrhosis or other significant liver disease
* Alanine aminotransferase or aspartate aminotransferase \>2 x upper limit of normal
* Most recent hospitalization was for non-cardiovascular or non-renal conditions
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 (11)
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
Richmond University Medical Center (RUMC)
Staten Island
New York
Recruiting
Research Innovations, LLC
Beavercreek
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
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.
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