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Inhaled Vardenafil for Pulmonary Arterial Hypertension (VIPAH-PRN 2B Trial)
VIPAH-PRN 2B Trial Summary
This trial is testing a new drug to see if it can help people with pulmonary arterial hypertension by improving their exercise parameters.
VIPAH-PRN 2B Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowVIPAH-PRN 2B Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.VIPAH-PRN 2B Trial Design
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Who is running the clinical trial?
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- I've had a scan that shows I don't have CTEPH.I am using non-oral medication for pulmonary arterial hypertension.I have severe liver disease or hypertension related to liver problems.I have irregular heartbeats that are sudden or not well-controlled.I am between 18 and 80 years old.I have a history of fainting or sudden drops in blood pressure.I have a history of heart disease affecting the left side of my heart.I have experienced sudden hearing loss.I haven't used any nitrates in any form for at least 2 weeks.You have a specific heart condition called Eisenmenger's syndrome or a certain type of heart defect.I have a long-term asthma condition that is not well-controlled.My heart's electrical activity, measured by ECG, is within normal limits.My pulmonary arterial hypertension is stable without major treatment changes.I have HIV with PAH and meet specific health criteria.I have been on a stable dose of my current medications for at least 1 month.I have had a right heart catheterization confirming pulmonary arterial hypertension.I can walk at least 150 meters without stopping.I experience moderate to severe symptoms affecting my daily activities.I am on up to 3 oral or inhaled treatments for PAH and my condition is stable.I have vision loss due to a specific type of optic nerve damage.Your hemoglobin level is less than 9 grams per deciliter at the initial check-up.I haven't had cancer, except for specific skin or cervical types, in the last 5 years.I have been part of a lung rehab or exercise program in the last 6 months.My pulmonary arterial hypertension is confirmed by a right heart catheterization.Your platelet count is less than 50,000 per microliter at the time of screening.I have needed IV medication to help my heart pump better within the last 30 days.Your blood pressure is too low at the start of the study.Your blood test shows that your ALT or AST levels are more than three times the normal range.I have had a procedure to create a hole in the wall between the upper chambers of my heart.I have severe kidney problems or need dialysis.My high blood pressure is not under control.
- Group 1: RT234 1.0 mg Cohort 2
- Group 2: RT234 0.5 mg Cohort 1
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this particular research project allow for elderly participation?
"The age range for this study is 18-80 years old."
Where can patients enroll in this study?
"This phase 3 clinical trial is being conducted at various locations throughout the United States, including but not limited to: University of Chicago Medical Center in Chicago, Illinois; Washington University in Saint Louis, Missouri; and Ochsner Louisiana State University Health in Shreveport, Louisiana."
How many people fit the criteria to join this experiment?
"That is correct, the online clinicaltrial database has this trial listed as currently looking for 86 participants from 16 different locations. The posting dates indicate that the study was first put up on September 25th 2020 with the most recent update being October 27th 2022."
Are there any documented dangers of RT234 - vardenafil inhalation powder; when used with the Axially Oscillating Sphere dry powder inhaler (AOS DPI)?
"This particular Phase 2 trial for the new drug RT234 - vardenafil inhalation powder; Device: Axially Oscillating Sphere dry powder inhaler (AOS DPI) has not yet yielded data to support efficacy, only safety. Therefore, it was given a score of 2."
Are there any unfilled positions in this research project?
"The most recent information on clinicaltrials.gov reveals that this experiment is still looking for participants. The listing was first posted on September 25th, 2020 with the last update being October 27th, 2020."
What goals does this research aim to achieve?
"The primary outcome variable that will be monitored over the course of the study is change in blood pressure. Additionally, researchers will compare changes in pulse oximetry response to exercise, oxygen uptake efficiency slope, and ventricular arrhythmia frequency from baseline to post-treatment."
Are there any precedents for the use of RT234 - vardenafil inhalation powder with the Axially Oscillating Sphere dry powder inhaler (AOS DPI)?
"Currently, there are 3 ongoing studies for the combination of Drug: RT234 - vardenafil inhalation powder and Device: Axially Oscillating Sphere dry powder inhaler (AOS DPI). 0 of those studies are in Phase 3. Most of these investigations are taking place in Temple, Texas, but 20 other locations across the United States are also conducting research."
Could I qualify to take part in this clinical trial?
"This study is currently enrolling 86 participants that have been diagnosed with pulmonary arterial hypertension. ages ranging from 18 to 80 years old are eligible. There are a few key points worth mentioning in regards to the inclusion criteria: first, patients must have had a V/Q scan, CT angiogram, or pulmonary arteriogram within 6 months of Screening Visit 1 which rules out chronic thromboembolic pulmonary hypertension. Secondly, patients must be on stable PAH medication for 3 months prior to the CPET procedure and cannot have changed their dose within 1 month of Screening. Lastly, if the patient is taking corticoster"
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