Study of Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension
Recruiting · NCT07511361 · Interventional (participants receive a specific treatment) · Lead sponsor: Kardigan, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboTonlamarsen
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
- Key
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
Where it is running
11 locations listed across 8 US states.
- Western Nephrology and Metabolic Bone Disease, PC - Arvada - Arvada, Colorado, United States
- Homestead Associates in Research - Homestead, Florida, United States
- Progressive Medical Research - Port Orange, Florida, United States
- Eagle Clinical Research - Chicago, Illinois, United States
- Richmond University Medical Center (RUMC) - Staten Island, New York, United States
- Research Innovations, LLC - Beavercreek, Ohio, United States
- OnSite Clinical Solutions, LLC - Fort Mill, South Carolina, United States
- Chattanooga Research & Medicine CHARM - Chattanooga, Tennessee, United States
- Laguna Clinical Research Associates - Laredo, Texas, United States
- Tapia Internal Medicine Clinic - Paris, Texas, United States
- Baylor Scott and White Research Institute - Temple - Temple, Texas, United States