Ninerafaxstat 200mg MR
DrugNinerafaxstat 200mg Modified Release tablet administered BID
NCT Number: NCT07023614
FORTITUDE-HCM is a global, multicenter, double-blind, parallel-group, placebo-controlled Phase 2b study that will assess the efficacy and safety of ninerafaxstat compared to placebo on top of Standard of Care in patients with symptomatic nHCM
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Imbria Investigational Site, Graz, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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Other protocol-defined inclusion and exclusion criteria apply.
Ninerafaxstat 200mg Modified Release tablet administered BID
Matching placebo tablet administered BID
Time frame: Baseline to Week 12
The Clinical Summary Score is a merging of symptom frequency and symptom burden domains into a total symptom score combined with the physical limitation domain. Scoring ranges from 0 to 100, with higher scores indicating better health status.
Time frame: Baseline to Week 12
Time frame: Baseline to Week 12
The Total Symptom Score is a merging of symptom frequency and symptom burden domains. Scoring ranges from 0 to 100, with higher scores indicating better health status.
Time frame: Baseline to Week 12
The Physical Limitations Score is a single-domain score. Scoring ranges from 0 to 100, with higher scores indicating better health status.
Time frame: Baseline to Week 12
The Overall Summary Score is a merging of symptom, physical limitations, social limitations, and quality of life domains. Scoring ranges from 0 to 100, with higher scores indicating better health status.
Contact information is provided by the study sponsor or research team.
Imbria Pharmaceuticals, Inc.
Industry
A Global Phase 2b, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy - FORTITUDE-HCM
Acronym: FORTITUDE-HCM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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