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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.
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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tonlamarsen | Experimental | 3 doses active drug will be administered by subcutaneous (under the skin) injection (one dose every 4 weeks) |
|
| Placebo | Placebo Comparator | 3 doses of placebo will be administered by subcutaneous (under the skin) injection (one dose every 4 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tonlamarsen | Drug | Tonlamarsen will be administered subcutaneously (under the skin) every 4 weeks during the randomized part of the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: To assess variability in clinical and biomarker measures to inform Part B sample-size estimation and study-design assumptions |
| Baseline through Week 12 |
| Part B: To assess the pharmacodynamic (PD) effect of tonlamarsen on plasma AGT levels | Percent change in plasma AGT levels from Baseline to Week 4 | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: To assess the safety and tolerability of tonlamarsen compared with placebo |
| Week 36 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kardigan Clinical Study Information Team | Contact | +1-877-310-5135 | clinicaltrials@kardigan.bio |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Nephrology and Metabolic Bone Disease, PC - Arvada | Recruiting | Arvada | Colorado | 80002 | United States |
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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.
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| Placebo | Drug | Placebo will be administered subcutaneously (under the skin) every 4 weeks during the randomized part of the study |
|
| Part A: To assess the feasibility of using AGT levels and systolic blood pressure as efficacy endpoints |
| Baseline through Week 12 |
| Part B: To assess the safety and tolerability of tonlamarsen compared with placebo |
| Week 36 |
| Part B: To evaluate the effect of tonlamarsen on systolic blood pressure measured via daily home blood pressure monitoring | Change in time-averaged systolic blood pressure measured via daily home blood pressure monitoring from Baseline during Week 4 | Week 4 |
| Part B: To evaluate the effect of tonlamarsen on office systolic blood pressure | Change in office systolic blood pressure from Baseline to Week 4 | Week 4 |
| Part B: To assess the PD effect of tonlamarsen on plasma AGT levels | Percent change in plasma AGT levels from Baseline to Week 12 | Week 12 |
| Part B: To evaluate the effect of tonlamarsen on systolic blood pressure measured via daily home blood pressure monitoring | Change in time-averaged systolic blood pressure measured daily via home blood pressure monitoring from Baseline during Week 12 | Week 12 |
| Part B: To evaluate the effect of tonlamarsen on office systolic blood pressure | Change in office systolic blood pressure from Baseline to Week 12 | Week 12 |
| Homestead Associates in Research | Recruiting | Homestead | Florida | 33033 | United States |
|
| Progressive Medical Research | Recruiting | Port Orange | Florida | 32127 | United States |
|
| Richmond University Medical Center (RUMC) | Recruiting | Staten Island | New York | 10310 | United States |
|
| Research Innovations, LLC | Recruiting | Beavercreek | Ohio | 05431 | United States |
|
| Chattanooga Research & Medicine CHARM | Recruiting | Chattanooga | Tennessee | 37404 | United States |
|
| Laguna Clinical Research Associates | Recruiting | Laredo | Texas | 78041 | United States |
|
| Baylor Scott and White Research Institute - Temple | Recruiting | Temple | Texas | 76502 | United States |
|
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000096003 | Hypertensive Crisis |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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