An Adaptive Program of IKT-001 in Pulmonary Arterial Hypertension (PAH)
ConditionPulmonary Arterial Hypertension
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInhibikase Therapeutics
About this trial
This is an adaptive, 2-part, randomized, multicenter, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of IKT-001 in adult participants with WHO Group 1 PAH.
Eligibility criteria
Qualifiers
Idiopathic PAH
Heritable PAH
Drug/toxin-induced PAH
PAH associated with connective tissue disease (CTD)
Disqualifiers
Diagnosis of PAH WHO Groups 2, 3, 4, or 5.
Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension, schistosomiasis-associated PAH, and pulmonary veno-occlusive disease.
Any of the following blood pressure-related values or abnormalities: Uncontrolled systemic hypertension as evidenced by sitting systolic BP >160 mmHg or sitting diastolic BP >100 mmHg at screening, Baseline systolic BP <90 mmHg at screening, Syncope within 3 months prior to screening
History of restrictive, constrictive, or congestive cardiomyopathy.
Trial design
Treatments tested in this trial
- IKT-001
- Placebo
Treatment groups
486 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov