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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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The purpose of this study is to evaluate the efficacy, pharmacodynamics (PD), and safety of ALN-AGT01 RVR in participants with mild to moderate hypertension pretreated with zilebesiran.
This study will be conducted in 2 parts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALN-AGT1 RVR | Experimental | Participants will be administered a single dose of zilebesiran followed by a single dose of ALN-AGT01 RVR. |
|
| Placebo | Placebo Comparator | Participants will be administered a single dose of zilebesiran followed by a single dose of placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALN-AGT01 RVR | Drug | ALN-AGT01 RVR will be administered subcutaneously (SC) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Percentage recovery from baseline in serum AGT | Up to Day 4 | |
| Part B: Percentage recovery from baseline in mean seated office SBP | At Day 4 and Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Both Parts: Frequency of Adverse Events (AEs) | Up to 10 months | |
| Part A: Percentage recovery from baseline in serum AGT | Up to Day 7 | |
| Part B: Percentage recovery from baseline in serum AGT |
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Part A: Inclusion Criteria
Part B: Inclusion Criteria
Both Parts: Exclusion Criteria
Note: other protocol defined inclusion / exclusion criteria apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alnylam Clinical Trial Information Line | Contact | 1-877-ALNYLAM | clinicaltrials@alnylam.com | |
| Alnylam Clinical Trial Information Line | Contact | 1-877-256-9526 | clinicaltrials@alnylam.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Alnylam Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Recruiting | Lake Forest | California | 92630 | United States | |
Access to Anonymized individual participant data that support these results is made available 12 months after study completion and not less than 12 months after the product and indication have been approved in the US and/or the EU.
Access to data may be declined where there is likelihood a patient could be identified or other feasibility issue, where there is a potential conflict of interest, a planned business activities or an actual or potential competitive risk. Data will be provided contingent upon the approval of a research proposal and the execution of a data sharing agreement. Timeframes for data access may vary and can take up to 6 months or more.
Requests for access to data can be submitted via the website www.vivli.org. Questions can also be directed to datasharing@alnylam.com.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo |
| Drug |
Placebo will be administered SC |
|
| Zilebesiran | Drug | Zilebesiran will be administered SC |
|
| At Day 4 and Day 7 |
| Part B: Change from baseline in mean seated office SBP | At Day 4 and Day 7 |
| Clinical Trial Site |
| Recruiting |
| Tampa |
| Florida |
| 33613 |
| United States |
| Clinical Trial Site | Recruiting | Savannah | Georgia | 31405 | United States |