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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
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Two-Part Study to Evaluate the Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension
Who can join
Ages 18 and older · All sexes
Full 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
About the 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.
What is being tested
- Tonlamarsen (drug)
- Placebo (drug)
Sponsor: Kardigan, Inc. · Participants: 140 · Started: Jun 23, 2026
Contact the study team
- Kardigan Clinical Study Information Team · Phone: +1-877-310-5135
Official record on ClinicalTrials.gov — NCT07511361
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.