This is a multicenter, open-label extension (OLE), single-arm study designed to assess the long-term safety and tolerability of oral IKT-001 administered once daily.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
484
IKT-001 tablets for PO administration
Incidence of Treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs of special interest
The number of participants who experience a TEAE, serious TEAE or TEAE of special interest will be reported.
Time frame: From baseline to end of study (up to 2 years or availability of commercial product)
Change from baseline in 6-minute walk distance (6MWD)
Time frame: From baseline to end of study (up to 2 years or availability of commercial product)
Change from baseline in NT-proBNP
Time frame: From baseline to end of study (up to 2 years or availability of commercial product)
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