Clinical trials: PAH
Pulmonary Arterial Hypertension
Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1)
To evaluate the change from baseline in pulmonary vascular resistance (PVR), and other hemodynamic parameters, following the addition of ambrisentan to background phosphodiesterase type-5 inhibitor (PDE-5i) therapy in subjects…
- Trial name
- ATHENA-1 (NCT00617305)
- Testing
- Ambrisentan, Sildenafil, Tadalafil
- Where
- 30 sites in United States
- Volunteers
- 38 people
- Sponsor
- Gilead Sciences
Pulmonary Arterial Hypertension
BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology
This 6-month open label study will evaluate the long term safety of bosentan (via oxygen saturation) and efficacy (exercise capacity) in patients who have completed the BREATHE-5 study (PAH related to Eisenmenger physiology).
- Trial name
- NCT00367770
- Testing
- Tracleer®
- Where
- 17 sites in United States, Australia and 9 more
- Volunteers
- 37 people
- Sponsor
- Actelion
Pulmonary Arterial Hypertension
Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH
An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for Pulmonary Arterial Hypertension (PAH)
- Trial name
- NCT02652429
- Testing
- Inhaled Nitric Oxide
- Where
- 17 sites in United States, Canada
- Volunteers
- 22 people
- Sponsor
- Bellerophon Pulse Technologies
PAH
Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 Years
This was a multi-center, open-label, safety, tolerability and pharmacokinetic study of oral treprostinil in pediatric subjects with stable PAH aged 7 to 17 years who were (1) transitioning from parenteral Remodulin therapy; (2)…
- Trial name
- NCT02276872
- Testing
- oral treprostinil
- Where
- 9 sites in United States
- Volunteers
- 32 people
- Sponsor
- United Therapeutics
Pulmonary Arterial Hypertension
A Pharmacokinetics Study for Pediatric Participants With Pulmonary Arterial Hypertension
The purpose of this study is to see how much study drug is in the blood of children with pulmonary arterial hypertension (PAH) after dosing to establish the correct dose for further clinical research.
- Trial name
- NCT01484431
- Testing
- Tadalafil- Tablet or Oral suspension
- Where
- 16 sites in United States, Canada and 4 more
- Volunteers
- 20 people
- Sponsor
- Eli Lilly and Company
Hypertension, Pulmonary
Safety of Terbogrel in Patients With Primary Pulmonary Hypertension
Study to assess the safety of terbogrel during open-label, long-term treatment in medically stable or improving patients with primary pulmonary hypertension who have completed the 12-week, double-blind randomized trial of…
- Trial name
- NCT02223494
- Testing
- Terbogrel
- Volunteers
- 33 people
- Sponsor
- Boehringer Ingelheim
Interstitial Lung Disease, COPD
Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs
The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor lung that were preserved and transported within the LUNGguard system, as well as…
- Conditions
- Interstitial Lung Disease, COPD, Cystic Fibrosis, Pulmonary Fibrosis
- Trial name
- GUARDIANLUNG (NCT04930289)
- Testing
- LungGuard, BAROGuard
- Where
- 15 sites in United States, Belgium
- Volunteers
- 3,500 people
- Sponsor
- Paragonix Technologies
Hypertension, Pulmonary
Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients
The safety and efficacy at 100 mg once daily for oral dose of sitaxentan sodium were demonstrated in the STRIDE clinical trial program. Sitaxentan sodium was approved in the EU, Canada and Australia.
- Trial name
- NCT01210443
- Testing
- Sitaxentan
- Where
- 2 sites in Japan
- Volunteers
- 2 people
- Sponsor
- Pfizer
Pulmonary Arterial Hypertension
A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension
This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily by subjects with PAH until sitaxsentan, in a particular country or region, is commercially available for the treatment of PAH or the…
- Trial name
- STRIDE-3 (NCT00811018)
- Testing
- Sitaxsentan
- Where
- 91 sites in United States, Argentina and 14 more
- Volunteers
- 1,192 people
- Sponsor
- Pfizer
Phenylketonurias
A Prospective Clinical Study of Phenylketonuria (PKU)
This is a study for adults and children ≥ 14 years old who have Phenylketonuria (PKU) with uncontrolled plasma Phe levels. No clinical intervention or study drug is provided by BioMarin in this study.
- Trial name
- NCT04452513
- Where
- 14 sites in United States
- Volunteers
- 32 people
- Sponsor
- BioMarin Pharmaceutical
Pulmonary Arterial Hypertension
OPsumit USers Registry
Prospective observational drug registry developed to characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with…
- Trial name
- OPUS (NCT02126943)
- Testing
- Opsumit (macitentan)
- Where
- 146 sites in United States, Puerto Rico
- Volunteers
- 2,686 people
- Sponsor
- Actelion
Pulmonary Arterial Hypertension
Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States
The Opsumit Users registry (OPUS; NCT02126943) was developed to characterize the safety profile of Opsumit and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing…
- Trial name
- OrPHeUS (NCT03197688)
- Testing
- Notapplicable
- Where
- 106 sites in United States, Puerto Rico
- Volunteers
- 2,200 people
- Sponsor
- Actelion
Pulmonary Arterial Hypertension, Pulmonary Hypertension
Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety
As sitaxsentan is the agent most highly selective for ETA (Endothelin Type A (receptor)), and does not significantly impact sildenafil pharmacokinetics the combination of most promise for pulmonary arterial hypertension (PAH)…
- Trial name
- NCT00796510
- Testing
- Sitaxsentan, Sitaxsentan and Sildenafil
- Where
- 3 sites in United States, Romania and 1 more
- Volunteers
- 3 people
- Sponsor
- Pfizer
Idiopathic Pulmonary Arterial Hypertension, Cardiomyopathy
Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing
The primary purpose of this study is to compare the number of participants with reversible pulmonary hypertension (vasoreactivity) due to nitric oxide for inhalation and oxygen as compared to 100% oxygen.
- Trial name
- NCT00626028
- Testing
- Nitric Oxide for inhalation, Oxygen, Nitric Oxide plus Oxygen
- Where
- 18 sites in United States, France and 3 more
- Volunteers
- 136 people
- Sponsor
- Mallinckrodt
Hypertension, Pulmonary
Non-interventional, Postauthorization Safety Study of Ventavis for Pulmonary Arterial Hypertension (PAH)
This study is collecting post-marketing information on the safety and effectiveness of Ventavis under the routine clinical practice for patients with PAH
- Trial name
- NCT02825160
- Testing
- Ventavis (Iloprost, BAYQ6256)
- Where
- Japan
- Volunteers
- 282 people
- Sponsor
- Bayer
Hypertension, Pulmonary
Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)
The objective of this post-marketing surveillance study is to evaluate the incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan basd on prescribing information under the…
- Trial name
- NCT01406327
- Testing
- Ambrisentan
- Volunteers
- 900 people
- Sponsor
- GlaxoSmithKline
Hypertension, Pulmonary
Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529
An open label, long term extension to Study AMB112529. All subjects may remain in the extension study for a minimum of six months.
- Trial name
- NCT01342952
- Testing
- Ambrisentan
- Where
- 22 sites in United States, Argentina and 7 more
- Volunteers
- 38 people
- Sponsor
- GlaxoSmithKline
Hypertension, Pulmonary
Riociguat in Children With Pulmonary Arterial Hypertension (PAH)
This study was designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of riociguat at age-, sex- and body-weight-adjusted doses of 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID in children from ≥6 to…
- Trial name
- PATENT-CHILD (NCT02562235)
- Testing
- Riociguat (Adempas, BAY63-2521)
- Where
- 16 sites in Colombia, Germany and 7 more
- Volunteers
- 24 people
- Sponsor
- Bayer
Pulmonary Hypertension
Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension
To assess the safety of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1 and 2) To assess the efficacy after 12 weeks of treatment of sildenafil 20 mg TID orally given to Japanese…
- Trial name
- NCT00454207
- Testing
- sildenafil citrate (UK-92,480)
- Where
- 8 sites in Japan
- Volunteers
- 44 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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