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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKardigan, Inc.

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Tonlamarsen
  • Placebo

Treatment groups

140 Participants
are divided into 2 treatment groups

Sponsors and collaborators