Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study
Public ClinicalTrials.gov record NCT04266197. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2b, Open-label, Single Dose Study to Evaluate the Safety and Efficacy of RT234 on Exercise Parameters Assessed by Cardiopulmonary Exercise Testing (CPET) in Subjects With Pulmonary Arterial Hypertension (PAH)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT04266197
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 42 participants
Conditions and interventions
Conditions
Interventions
- Drug: RT234 - vardenafil inhalation powder; Device: Axially Oscillating Sphere dry powder inhaler (AOS DPI) Combination Product
Combination Product
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 25, 2020 (Actual)
- Primary completion
- Nov 20, 2024 (Actual)
- Completion
- Jan 7, 2025 (Actual)
- Last update posted
- Jul 13, 2026
2020 – 2025
United States locations
- U.S. sites
- 26
- U.S. states
- 19
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | — |
| University of Arizona | Tucson | Arizona | 85724 | — |
| UCLA | Los Angeles | California | 90024 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| UC Davis | Sacramento | California | 95618 | — |
| University of California San Francisco | San Francisco | California | 94143 | — |
| The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | 90502 | — |
| MedStar Heart and Vascular Institute | Washington D.C. | District of Columbia | 20010 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Norton Health | Louisville | Kentucky | 40202 | — |
| Ochsner Louisiana State University Health | Shreveport | Louisiana | 71103 | — |
| Tufts University | Boston | Massachusetts | 02111 | — |
| Mayo Clinic | Rochester | Minnesota | 20010 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| University of New Mexico | Albuquerque | New Mexico | 87131 | — |
| Mount Sinai Hospital | New York | New York | 10029 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | — |
| University Hospital | Cleveland | Ohio | 44106 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Ascension Seton Medical Center Austin | Austin | Texas | 78705 | — |
| Baylor Scott and White Institute | Dallas | Texas | 75246 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23284 | — |
| Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04266197, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 13, 2026 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04266197 live on ClinicalTrials.gov.