Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
NCT ID:
NCT05103332
Pre Assignment Details:
Before Protocol Amendment 3 (PA3), participants completing DB period could join a separate zilebesiran OLE study. Those completing DB before OLE study availability entered OLE period in this study to receive zilebesiran until transition. Others ineligible for OLE study/discontinued drug in DB could enter safety follow-up(SFU). With PA3, OLE period was closed \& plans for OLE study canceled. Ongoing DB participants entered SFU at completion; those in OLE stopped treatment \& transitioned to SFU.
Recruitment Details:
A total of 78 clinical sites in North America (66=United States \[US\] \& 12=Canada) \& 24 clinical sites in Europe (10=United Kingdom \[UK\]) enrolled participants in this study. 663 participants who met eligibility criteria after run-in with protocol-assigned background medication (indapamide, amlodipine, olmesartan) were randomized to zilebesiran or placebo in double-blind (DB) period, with the option to receive zilebesiran in open-label extension period (OLE). 1 month=28 days for this study.
Study:
NCT05103332
Study Brief:
Results Section:
NCT05103332