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NCT07511361
Study of Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension
Conditions: Hypertension, Acute Severe Hypertension, Hypertensive Emergency, Hypertensive Urgency
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 140
Sponsor: Kardigan, Inc.
Location: Western Nephrology and Metabolic Bone Disease, PC - Arvada Arvada Colorado
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 Criteria
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
Source: ClinicalTrials.gov (NCT07511361). StuddyBuddy aggregates publicly available trial information.