Clinical trials: PAH
Pulmonary Arterial Hypertension
Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso
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.
- Trial name
- BREEZE (NCT03950739)
- Testing
- Treprostinil Inhalation Powder
- Where
- 16 sites in United States
- Volunteers
- 51 people
- Sponsor
- United Therapeutics
Severe Pulmonary Arterial Hypertension
Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan
To provide continued treatment to Pulmonary Arterial Hypertension (PAH) patients who are benefitting from treatment with QTI571.
- Trial name
- NCT02042014
- Testing
- QTI571
- Where
- 3 sites in Japan
- Volunteers
- 8 people
- Sponsor
- Novartis Pharmaceuticals
Pulmonary Arterial Hypertension
Effects of Oral Sildenafil on Mortality in Adults With PAH
This is a blinded study in adult patients with PAH evaluating the relative effects of sildenafil on mortality when administered at the three doses (80 mg, 20 mg or 5 mg, all three times per day [TID]).
- Trial name
- AFFILIATE (NCT02060487)
- Testing
- sildenafil citrate
- Where
- 82 sites in United States, Australia and 21 more
- Volunteers
- 385 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Connective Tissue Disease-Associated Pulmonary Arterial Hypertension
Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST
This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with connective tissue disease-associated pulmonary arterial hypertension to determine the recommended dose range and evaluate the…
- Trial name
- NCT02657356
- Testing
- Bardoxolone methyl capsules
- Where
- 106 sites in United States, Argentina and 13 more
- Volunteers
- 202 people
- Sponsor
- Biogen
Pulmonary Arterial Hypertension
Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAH
Phase 3, placebo controlled, double-blind, randomized clinical study to determine safety, tolerability, and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in symptomatic subjects with pulmonary arterial…
- Trial name
- INOvation-1 (NCT02725372)
- Testing
- Inhaled Nitric Oxide 75 mcg/kg IBW/hr
- Where
- 109 sites in United States, Australia and 16 more
- Volunteers
- 207 people
- Sponsor
- Bellerophon Pulse Technologies
Pulmonary Arterial Hypertension
Selexipag (ACT-293987) in Pulmonary Arterial Hypertension
The AC-065A302 (GRIPHON) study is an event-driven Phase 3 study to demonstrate the effect of selexipag on time to first morbidity or mortality event in patients with pulmonary arterial hypertension.
- Trial name
- GRIPHON (NCT01106014)
- Testing
- Selexipag
- Where
- 182 sites in United States, Argentina and 37 more
- Volunteers
- 1,156 people
- Sponsor
- Actelion
Pulmonary Arterial Hypertension
Extension Study of Efficacy and Safety of LTP001 in Pulmonary Arterial Hypertension Participants
The purpose of this study was to measure the long-term safety and efficacy profile of LTP001 in participants with pulmonary arterial hypertension (PAH).
- Trial name
- NCT05764265
- Testing
- LTP001
- Where
- 12 sites in United States, Argentina and 5 more
- Volunteers
- 31 people
- Sponsor
- Novartis Pharmaceuticals
Pulmonary Arterial Hypertension
Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension
The primary objective of AC-052-373 was to assess the pharmacokinetic (PK) profile of two dosing regimens of the pediatric formulation of bosentan in children with pulmonary arterial hypertension (PAH) <12 years of age.
- Trial name
- FUTURE 3 (NCT01223352)
- Testing
- bosentan
- Volunteers
- 64 people
- Sponsor
- Actelion
Pulmonary Arterial Hypertension
A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR)
The objectives of this study are to evaluate the efficacy and safety of sotatercept (MK-7962) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) at 24 weeks in…
- Trial name
- NCT04576988
- Testing
- Sotatercept, Background PAH Therapy
- Where
- 120 sites in United States, Argentina and 19 more
- Volunteers
- 324 people
- Sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Pulmonary Arterial Hypertension
Iloprost Power 15 in Pulmonary Arterial Hypertension
Patients with symptomatic idiopathic pulmonary arterial hypertension (IPAH), or familial pulmonary arterial hypertension (FPAH) or pulmonary hypertension associated with Human immunodeficiency virus (HIV) or drugs/toxins in New…
- Trial name
- PROWESS 15 (NCT00709956)
- Testing
- iloprost (5 µg)
- Volunteers
- 64 people
- Sponsor
- Actelion
Pulmonary Arterial Hypertension
An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial Hypertension
This study provided/continued to provide oral treprostinil (UT-15C SR; treprostinil diethanolamine) to eligible subjects who participated in Studies TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, and TDE-PH-308.
- Trial name
- FREEDOM-EXT (NCT01027949)
- Testing
- Oral Treprostinil
- Where
- 134 sites in United States, Australia and 18 more
- Volunteers
- 894 people
- Sponsor
- United Therapeutics
Vascular Disease
Efficacy Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension (PAH)
This open label, single-arm, non-controlled, multicentre study will determine the effect of ambrisentan on exercise capacity (6MWT) in Chinese subjects with PAH.
- Trial name
- NCT01808313
- Testing
- ambrisentan
- Where
- 12 sites in China
- Volunteers
- 134 people
- Sponsor
- GlaxoSmithKline
Pulmonary Arterial Hypertension
Pharmacokinetics, Safety and Efficacy of BIA 5-1058 in PAH (Zamicastat)
This Study evaluates the pharmacokinetic (PK) profile of different zamicastat doses in Pulmonary arterial hypertension (PAH) patients to find the most promising therapeutic dosage range for the treatment of PAH disease
- Trial name
- NCT04316143
- Testing
- Oral zamicastat
- Where
- 13 sites in Austria, Germany and 5 more
- Volunteers
- 33 people
- Sponsor
- Bial - Portela C S.A.
Hypertension, Pulmonary
Study the Safety and Effectiveness of Tadalafil on High Blood Pressure in the Blood Vessel Going From the Heart to the Lungs
Study to determine the long term safety of tadalafil in patients with increased blood pressure in the blood vessel that carries blood from the right heart to the lungs and to see if it will keep the disease from getting worse.
- Trial name
- NCT00549302
- Testing
- tadalafil
- Where
- 10 sites in United States, Belgium and 8 more
- Volunteers
- 357 people
- Sponsor
- Eli Lilly and Company
Pulmonary Arterial Hypertension
A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension
The purpose of this study to confirm the selexipag starting dose(s), selected based on pharmacokinetic (PK) extrapolation from adults, that leads to similar exposure as adults doses in children from greater than or equal to (>=)…
- Trial name
- NCT03492177
- Testing
- selexipag (Uptravi)
- Where
- 34 sites in United States, Belarus and 14 more
- Volunteers
- 63 people
- Sponsor
- Actelion
Pulmonary Arterial Hypertension
Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Participants
The purpose of this study was to investigate the effects of QTI571 (imatinib) on pharmacokinetics of bosentan and sildenafil at steady state when co-administered to participants with pulmonary arterial hypertension.
- Trial name
- NCT01392469
- Testing
- Imatinib, Sildenafil, Bosentan
- Where
- 11 sites in United States, Australia and 5 more
- Volunteers
- 21 people
- Sponsor
- Novartis Pharmaceuticals
Pulmonary Arterial Hypertension
Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension
The AC-055-302/SERAPHIN study will be an event-driven Phase III study, comparing two different doses of macitentan (ACT-064992) (3 and 10 mg) vs placebo in patients with symptomatic PAH.
- Trial name
- SERAPHIN (NCT00660179)
- Testing
- macitentan (ACT-064992)
- Where
- 153 sites in United States, Argentina and 36 more
- Volunteers
- 742 people
- Sponsor
- Actelion
Pulmonary Arterial Hypertension
Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Patients With Pulmonary Arterial Hypertension
This study enrolls patients with pulmonary arterial hypertension (PAH) treated with inhaled treprostinil. During the study, the treatment with inhaled treprostinil will be tapered off and simultaneously replaced with an oral…
- Trial name
- TRANSIT-1 (NCT02471183)
- Testing
- Selexipag
- Where
- 15 sites in United States
- Volunteers
- 34 people
- Sponsor
- Actelion
Pulmonary Arterial Hypertension
Clinical Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument
SYMPHONY is prospective, multi-center, open-label, single-arm, Phase 3b psychometric validation study of the PAH-SYMPACT, a new quality of life questionnaire for patients with pulmonary arterial hypertension.
- Trial name
- NCT01841762
- Testing
- Macitentan
- Where
- 81 sites in United States
- Volunteers
- 284 people
- Sponsor
- Actelion
Pulmonary Arterial Hypertension, Hypertension, Pulmonary
Safety And Efficacy Of Sildenafil In Children With Pulmonary Arterial Hypertension
Pulmonary arterial hypertension (PAH) is a rare, progressive, and life-threatening disease. In many patients, the course of PAH is a steady deterioration and reduced life expectancy.
- Trial name
- NCT01642407
- Testing
- Sildenafil
- Where
- 5 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.