Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso
NCT03950739 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51
Last updated 2024-11-01
Summary
This was a Phase 1b safety and tolerability single-sequence study in which PAH subjects on a stable regimen of Tyvaso switched to a corresponding dose of TreT.
Conditions
Interventions
- DRUG
-
Treprostinil Inhalation Powder
Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)
Sponsors & Collaborators
-
United Therapeutics
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-17
- Primary Completion
- 2023-08-22
- Completion
- 2023-08-22
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Heart Failure With Preserved Ejection Fraction
NCT03037580 ·Status: TERMINATED ·Phase: PHASE3
-
Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH)
NCT00147199 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Inhaled Treprostinil in Patients With PAH
NCT01557647 ·Status: WITHDRAWN ·Phase: PHASE3
-
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension
NCT05147805 ·Status: COMPLETED ·Phase: PHASE2
-
Tyvaso Dosing and Titration Evaluation: TyTRATE Registry
NCT01799473 ·Status: COMPLETED
-
A Study of Treprostinil Palmitil Inhalation Powder (TPIP) In Pulmonary Arterial Hypertension (PAH)
NCT04791514 ·Status: TERMINATED ·Phase: PHASE2
-
Safety, Tolerability, Pharmacokinetics and Efficacy of Two Different Rates of Subcutanous Remodulin® Dose Titration in Pulmonary Arterial Hypertension
NCT02893995 ·Status: WITHDRAWN ·Phase: PHASE4
-
An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension
NCT01560637 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Observe the Safety, Tolerability, and Efficacy of Remodulin
NCT06603285 ·Status: NOT_YET_RECRUITING
-
A Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Participants With Pulmonary Arterial Hypertension
NCT05203510 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
Efficacy and Safety of Treprostinil in Intermediate-Risk Pulmonary Arterial Hypertension
NCT07177703 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Transition From Injectable Prostacyclin Medication to Inhaled Prostacyclin Medication
NCT01268553 ·Status: COMPLETED ·Phase: PHASE4
-
Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 Years
NCT02276872 ·Status: COMPLETED ·Phase: PHASE2
-
Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)
NCT03794583 ·Status: TERMINATED ·Phase: PHASE3
-
Effects of Inhaled Treprostinil on Exercise Performance in Exercise Induced Pulmonary Hypertension
NCT07116681 ·Status: NOT_YET_RECRUITING ·Phase: EARLY_PHASE1
-
Inhaled Treprostinil for PAH: Open-label Extension
NCT01557660 ·Status: WITHDRAWN ·Phase: PHASE3
-
A Pharmacokinetic Substudy of the TDE-PH-304 Protocol
NCT01934582 ·Status: COMPLETED ·Phase: PHASE3
-
Investigational Trial to Evaluate Safety and Tolerability of Treprostinil in Children Diagnosed With PAH
NCT06350032 ·Status: RECRUITING ·Phase: PHASE3
-
Study Of Right Ventricular Performance In PAH Patients Treated With Rapid Dose Treprostinil (Remodulin)
NCT02074449 ·Status: COMPLETED
-
Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF
NCT03043651 ·Status: TERMINATED ·Phase: PHASE3
-
This Study Tests the Safety of Inhaled BAY1237592, How the Drug is Tolerated and How it Effects Patients With High Blood Pressure in the Arteries of the Lungs in the Two Different Disease Groups Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
NCT03754660 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 3 Study to Evaluate the Safety and Tolerability of L606 in Subjects With PAH or PH-ILD
NCT04691154 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Dry Powder Inhalation of Treprostinil
NCT03992755 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Transitioning To IV Remodulin From Ventavis in Patients With PAH: Safety, Efficacy and Treatment Satisfaction
NCT00458042 ·Status: TERMINATED ·Phase: PHASE4
-
An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
NCT07234032 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3