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A Dose Escalation Study to Evaluate the Effect of RT234 in Subjects With Pulmonary Arterial Hypertension | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Dose Escalation Study to Evaluate the Effect of RT234 in Subjects With Pulmonary Arterial Hypertension

A Phase 2a, Dose Escalation Study to Evaluate the Effect of RT234 on Cardiopulmonary Hemodynamics in Subjects With Pulmonary Arterial Hypertension

NCT05343637•Respira Therapeutics, Inc.

View on ClinicalTrials.gov

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

Detailed Description

The drawbacks of current therapies and the lack of an approved as needed (PRN) treatment for PAH that improves exercise ability and quality of life, form the basis for development of RT234 (inhaled vardenafil). The current study will identify the effective dose(s) of RT234 to acutely improve pulmonary vascular hemodynamics when delivered in a dose escalation manner in subjects with World Health Organization (WHO) Group 1 PAH undergoing RHC. In addition, this study will also provide valuable efficacy and safety insights into the interactions between RT234 and background disease-specific PAH therapy on pulmonary hemodynamics and right heart function.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Between 18 and 80 years of age, inclusive.
•2. 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):
•1. Systemic sclerosis (scleroderma)
•2. Limited scleroderma
•3. Mixed connective tissue disease
•4. Systemic lupus erythematosus
•5. Overlap syndrome
•6. Other autoimmune disorders;
•OR PAH associated with:
•1. Human immunodeficiency virus (HIV) infection with no evidence of opportunistic infection in the preceding 6 months;
+9 more criteria

Exclusion Criteria

•1. Baseline systemic hypotension, defined as MAP \< 50 mmHg or systolic blood pressure (SBP)\< 90 mmHg at Screening.
•2. Requirement of intravenous inotropes within 30 days prior to RHC procedure.
•3. Use of oral, topical or inhaled nitrates within 14 days prior to RHC procedure.
•4. Uncontrolled systemic hypertension: SBP \> 160 mmHg or diastolic blood pressure (DBP) \>100 mmHg at Screening.
•5. 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).
•6. Chronic renal insufficiency as defined by serum creatinine \> 2.5 mg/dL at Screening or requires dialysis.
•7. History of atrial septostomy.
•8. Unrepaired congenital heart disease (CHD).
•9. Pericardial constriction; restrictive or congestive cardiomyopathy.
•10. History of left ventricular ejection fraction (EF) \< 40% by multiple gated acquisition scan (MUGA), angiography, echocardiography, or cardiac magnetic resonance imaging (CMRI).
+5 more criteria

Locations (3)

St Vincent's Hospital

Darlinghurst, New South Wales, Australia

Royal Hobart Hospital

Hobart, Tasmania, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Key Dates

Start Date

July 30, 2019

Primary Completion Date

January 17, 2020

Completion Date

January 17, 2020

Last Updated

April 25, 2022

Enrollment

ACTUAL participants

Conditions

Pulmonary Arterial Hypertension

Interventions

Drug: RT234 - vardenafil inhalation powder; Device: RS01 dry powder inhaler (RS01 DPI)

COMBINATION_PRODUCT

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A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 25, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Dose Escalation Study to Evaluate the Effect of RT234 in Subjects With Pulmonary Arterial Hypertension

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

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