A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tonlamarsen in Participants With Acute Severe Hypertension Recently Discharged From the Hospital
Kardigan, Inc.
Summary
The purpose of this study is to evaluate the blood pressure-lowering effect of tonlamarsen in adult participants who were recently discharged from the hospital, after treatment for 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 * Recently discharged from the hospital to home within the past 3 days during which evaluation and/or treatment of acute severe hypertension (documented systolic blood pressure \>180 mmHg and/or diastolic \>110 mmHg) occurred, as measured by a healthcare provider within the 24 hours preceding hospitalization or during the initial 24 hours of hospitalization * At Screening and Randomization visit, average systolic blood pressure \> 145 mmHg * Presence of established cardiovascular or renal comorbidities Key Exclusion Criteria: *…
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 (4)
- Western Nephrology and Metabolic Bone Disease, PC - ArvadaArvada, Colorado
- Homestead Associates in ResearchHomestead, Florida
- Progressive Medical ResearchPort Orange, Florida
- Chattanooga Research & Medicine CHARMChattanooga, Tennessee