Study of Efficacy and Safety of Tonlamarsen in Participants With Acute Severe Hypertension Recent… (NCT07511361) | Clinical Trial Compass
RecruitingPhase 2
Study of Efficacy and Safety of Tonlamarsen in Participants With Acute Severe Hypertension Recently Discharged From the Hospital
United States100 participantsStarted 2026-04-20
Plain-language summary
The purpose of this study is to evaluate the blood pressure-lowering effect of tonlamarsen in adult participants who were recently discharged from the hospital, after treatment for acute severe hypertension.
Who can participate
Age range18 Years
SexALL
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Key Inclusion Criteria:
* Age 18 or older, body weight ≥ 50 kg
* Recently discharged from the hospital to home within the past 3 days during which evaluation and/or treatment of acute severe hypertension (documented systolic blood pressure \>180 mmHg and/or diastolic \>110 mmHg) occurred, as measured by a healthcare provider within the 24 hours preceding hospitalization or during the initial 24 hours of hospitalization
* At Screening and Randomization visit, average systolic blood pressure \> 145 mmHg
* Presence of established cardiovascular or renal comorbidities
Key Exclusion Criteria:
* Has known history of secondary hypertension
* Any malignancy requiring treatment within 5 years
* Has abnormal thyroid function with clinical significance
* Recent hospitalization for stroke, type 1 myocardial infarction or coronary revascularization within 3 months prior to the first on-study visit
* 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
What they're measuring
1
To assess the effect of tonlamarsen on plasma angiotensinogen (AGT) levels
Timeframe: Week 12
2
To assess the systolic blood pressure-lowering effect of tonlamarsen