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) |
|
|
Placebo Comparator Placebo |
3 doses of placebo will be administered by subcutaneous (under the skin) injection (one dose every 4 weeks) |
|
Recruiting Locations
Arvada, Colorado 80002
Homestead, Florida 33033
Port Orange, Florida 32127
Staten Island, New York 10310
Beavercreek, Ohio 05431
Chattanooga, Tennessee 37404
Laredo, Texas 78041
Temple, Texas 76502
More Details
- Status
- Recruiting
- Sponsor
- Kardigan, Inc.
Detailed Description
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 doses of tonlamarsen for approximately 3 months - Visit the clinic about 7 times, including initial evaluation, checkups, tests, and follow-up