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Completed Phase 2 Interventional

Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study

ClinicalTrials.gov ID: NCT04266197

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.

ClinicalTrials.gov public records Last synced May 6, 2026, 2:06 AM EDT

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)

Study identification

NCT ID
NCT04266197
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Respira Therapeutics, Inc.
Industry
Enrollment
42 participants

Conditions and interventions

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 24, 2020
Primary completion
Nov 19, 2024
Completion
Jan 6, 2025
Last update posted
Sep 17, 2025

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 Sep 17, 2025 · Synced May 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04266197 live on ClinicalTrials.gov.

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