A Dose Escalation Study to Evaluate the Effect of RT234 in Subjects With Pulmonary Arterial Hyper… (NCT05343637) | Clinical Trial Compass
CompletedPhase 2
A Dose Escalation Study to Evaluate the Effect of RT234 in Subjects With Pulmonary Arterial Hypertension
Australia14 participantsStarted 2019-07-30
Plain-language summary
This multicenter, open label, Phase 2a study is designed to evaluate the effect of inhaled RT234 delivered in a dose escalation manner on the change in pulmonary vascular resistance (PVR) in subjects with Pulmonary Arterial Hypertension (PAH) undergoing Right heart catheterization (RHC).
This study is also known as Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2a (VIPAH-PRN 2a) study
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Between 18 and 80 years of age, inclusive.
✓. Diagnosis of RHC-confirmed WHO Group 1 PAH in any of the following three categories: Idiopathic, primary or familial pulmonary arterial hypertension (IPAH, PPH, or FPAH); OR PAH associated with one of the following connective tissue diseases (CTD):
✓. Systemic sclerosis (scleroderma)
✓. Limited scleroderma
✓. Mixed connective tissue disease
✓. Systemic lupus erythematosus
✓. Overlap syndrome
✓. Other autoimmune disorders;
Exclusion criteria
✕. Baseline systemic hypotension, defined as MAP \< 50 mmHg or systolic blood pressure (SBP)\< 90 mmHg at Screening.
✕. Requirement of intravenous inotropes within 30 days prior to RHC procedure.
✕. Use of oral, topical or inhaled nitrates within 14 days prior to RHC procedure.
✕. Uncontrolled systemic hypertension: SBP \> 160 mmHg or diastolic blood pressure (DBP) \>100 mmHg at Screening.
✕. History of portal hypertension or chronic liver disease, including active viral replication of hepatitis B and/or hepatitis C or classified as having moderate to severe hepatic impairment (Child-Pugh Class B-C).
What they're measuring
1
Evaluation of adverse events (AEs)
Timeframe: Screening to Day 30
2
Peak plasma concentration (Cmax)
Timeframe: At baseline, 5, 15, 30, 45 and 60 minutes post-end of inhalation for the first RT234 dose and at 5, 15, 30, 45, 60, 75, 90, 105 and 120 minutes post-end of inhalation for the second RT234 dose.
3
Time to peak plasma concentration (Tmax)
Timeframe: At baseline, 5, 15, 30, 45 and 60 minutes post-end of inhalation for the first RT234 dose and at 5, 15, 30, 45, 60, 75, 90, 105 and 120 minutes post-end of inhalation for the second RT234 dose.
4
Area under the plasma concentration versus time curve (AUC)
Timeframe: At baseline, 5, 15, 30, 45 and 60 minutes post-end of inhalation for the first RT234 dose and at 5, 15, 30, 45, 60, 75, 90, 105 and 120 minutes post-end of inhalation for the second RT234 dose.
5
Terminal half-life
Timeframe: At baseline, 5, 15, 30, 45 and 60 minutes post-end of inhalation for the first RT234 dose and at 5, 15, 30, 45, 60, 75, 90, 105 and 120 minutes post-end of inhalation for the second RT234 dose.
6
Change in pulmonary vascular resistance (PVR)
Timeframe: At baseline, 5, 15, 30, 45 and 60 minutes post-end of inhalation for the first RT234 dose and at 5, 15, 30, 45, 60, 75, 90, 105 and 120 minutes post-end of inhalation for the second RT234 dose on Day 1.