Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study (NCT04266197) | Clinical Trial Compass
CompletedPhase 2
Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study
United States42 participantsStarted 2020-09-25
Plain-language summary
The objectives of this study are to evaluate the safety of RT234 and the effects of RT234 on exercise capacity as assessed by Cardiopulmonary Exercise Testing (CPET) and six minute walk testing (6MWT) as well as exertional symptoms in patients with pulmonary arterial hypertension (PAH).
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Must be between 18 and 80 years of age, inclusive.
. Must be willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to undergoing any research-related procedures.
. Must be willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
. Able to exercise during CPET and ambulate independently.
. Diagnosis documented and confirmed by Right Heart Catheterization (RHC)-confirmed WHO Group 1 PAH in any of the following 3 categories:
. Idiopathic, primary, or familial pulmonary arterial hypertension (IPAH, PPH, or FPAH) OR
. PAH associated with one of the following connective tissue diseases:
. Subjects with a diagnosis of HIV must have stable disease, defined by:
Exclusion criteria
. Baseline systemic hypotension defined as mean arterial pressure (MAP) \< 50 mmHg or SBP \< 90 mmHg at Screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Change in Peak Oxygen Uptake at Peak Exercise During CPET (Peak VO2)
Timeframe: Comparison of measure between baseline and treatment CPETs, typically ~14 days apart
2
Median Change in Peak Oxygen Uptake at Peak Exercise During CPET (Peak VO2)
Timeframe: Comparison of measure between baseline and treatment CPETs, typically ~14 days apart
. History of chronic uncontrolled asthma; subjects with inability to use, or may have potential difficulties using, an inhaler device.
. Use of continuous, supplemental oxygen. Subject must be able to complete exercise tests without the use of supplemental oxygen.
. Requirement of intravenous inotropic therapies within 30 days prior to the Baseline CPET procedure.
. Use of riociguat (Adempas®) as background PAH therapy as of 1 month prior to initiating Screening or during the study through the end of Visit 4.
. Use of oral, topical, or inhaled nitrates within 2 weeks prior to the Baseline CPET procedure.
. Has history of uncontrolled systemic hypertension as evidenced by sitting SBP \> 175 mmHg or sitting diastolic blood pressure (DBP) \> 110 mmHg at Screening.
. Portopulmonary hypertension, portal hypertension, or chronic liver disease determined to be Child-Pugh B or C, including hepatitis B virus and/or hepatitis C virus (HCV). Subjects who have had a previous infection with HCV and who have a negative viral load after receiving a course of curative treatment are