Overview
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.
Description
The Sponsor is studying an investigational medication called tonlamarsen to determine if it can help people recently treated for acute severe hypertension (hypertensive emergency and urgency).
The purpose of this study is to evaluate how well tonlamarsen works compared to a placebo and to see how safe it is for people following a recent episode of acute severe hypertension. Tonlamarsen is designed to block the body's liver from making a protein called angiotensinogen (AGT), which plays a key role in controlling blood pressure.
The main goals of the study are:
- To assess the effect of tonlamarsen on the amount of AGT in blood over time
- To assess the effect of tonlamarsen on blood pressure
- To evaluate the safety and tolerability of tonlamarsen
Participants will:
- Receive monthly doses of tonlamarsen for approximately 3 months
- Visit the clinic about 6 times, including initial evaluation, checkups, tests, and follow-up
Eligibility
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
