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
Kardigan, Inc.
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.
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 tonla…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 di…
Interventions
- DrugTonlamarsen
Tonlamarsen will be administered subcutaneously (under the skin) every 4 weeks during the randomized part of the study
- DrugPlacebo
Placebo will be administered subcutaneously (under the skin) every 4 weeks during the randomized part of the study
Locations (8)
- Western Nephrology and Metabolic Bone Disease, PC - ArvadaArvada, Colorado
- Homestead Associates in ResearchHomestead, Florida
- Progressive Medical ResearchPort Orange, Florida
- Richmond University Medical Center (RUMC)Staten Island, New York
- Research Innovations, LLCBeavercreek, Ohio
- Chattanooga Research & Medicine CHARMChattanooga, Tennessee