Safety, Pharmacokinetics and Efficacy Study of QCC374 in PAH Patients (NCT02927366) | Clinical Trial Compass
TerminatedPhase 2
Safety, Pharmacokinetics and Efficacy Study of QCC374 in PAH Patients
Stopped: Study was terminated early for strategic reasons. Only Part I of the study was completed.
United States, Germany, South Korea8 participantsStarted 2017-09-19
Plain-language summary
This was a non-confirmatory, randomized, placebo controlled, subject and investigator blinded study of QCC374 in PAH subjects. The study was planned to have 2 Parts: Part 1, an initial safety cohort with a 0.03 mg bid starting dose, and Part 2, a larger cohort with a 0.06 mg bid starting dose. However, due to early study termination following Part 1, Part 2 was not completed. Both study parts were comprised of four phases: a screening period for up to 28 days, a titration period of 2 weeks, a stable dose period of 14 weeks and safety follow-up period for 28 days. At the end of the treatment period of 16 weeks, eligible patients were given the option to participate in a separate long-term extension study (CQCC374X2201E1 (NCT02939599)), where all patients were treated with an individual optimal dose of QCC374.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female patients 18 years of age or older with symptomatic PAH.
* Subjects with PAH belonging to one of the following subgroups of the Updated Clinical Classification Group 1 (Nice, 2013):
* Idiopathic PAH
* familial PAH
* PAH associated with connective tissue disease, congenital heart disease (surgically repaired at least 12 months prior to screening) or drug or toxin induced (for example, anorexigen use).
* Subjects must have persistent symptoms due to PAH despite therapy with at least one of the following PAH medications: an endothelin receptor antagonist, asoluble guanylate cyclase stimulator or a phosphodiesterase inhibitor. The subjects' PAH medication regimen, with typical medications including calcium channel blockers, endothelin receptor antagonists, soluble guanylate cyclase stimulators and/or phosphodiesterase inhibitors, must have been used at a stable dose and frequency for at least 12 weeks before the screening visit and during the screening period.
* Diagnosis of PAH established according to the standard criteria before the screening visit:
* Resting mean pulmonary arterial pressure \> 25 mmHg.
* PVR \> 240 dynes s/cm5.
* Pulmonary capillary wedge pressure or left ventricular end diastolic pressure \< 15 mmHg
* PVR \> 400 dynes s/cm5 at the time of the baseline right heart catheterization (RHC) (if a RHC was completed within one month of the screening visit, that result may be used for inclusion).
* 6-minute walk distance greater …
What they're measuring
1
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 16 (Day 111)