Dysautonomia International

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

Purpose

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.

Conditions

Hypertension
Acute Severe Hypertension
Hypertensive Emergency
Hypertensive Urgency

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Double-Blind, Placebo-Controlled, Multicenter Two-Part study. Once eligibility is confirmed, eligible participants will then be randomized to tonlamarsen or placebo. The randomized treatment period will be followed by a 24-week safety follow-up period.
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Tonlamarsen	3 doses active drug will be administered by subcutaneous (under the skin) injection (one dose every 4 weeks)	Drug: Tonlamarsen Tonlamarsen will be administered subcutaneously (under the skin) every 4 weeks during the randomized part of the study
Placebo Comparator Placebo	3 doses of placebo will be administered by subcutaneous (under the skin) injection (one dose every 4 weeks)	Drug: Placebo Placebo will be administered subcutaneously (under the skin) every 4 weeks during the randomized part of the study