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Study of Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension

Sponsored by Kardigan, Inc.

About this study

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.

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 d…

Where this study is enrolling (11)

Show all 11 locations
Who can participate

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

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

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Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.