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Pulmonary Arterial Hypertension clinical trials

View clinical trials related to Pulmonary Arterial Hypertension.

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NCT ID: NCT01431716 Completed - Clinical trials for Pulmonary Arterial Hypertension

Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial Hypertension

EPITOME-2
Start date: March 2011
Phase: Phase 3
Study type: Interventional

This study is investigating the effect of switching from Flolan® to Epoprostenol for Injection (EFI/ACT-385781A) in pulmonary arterial hypertension patients currently treated with Flolan®. For this purpose patients being treated for at least 12 months with Flolan® will be switched from Flolan® to EFI/ACT-385781A and followed-up for 90 days. During these 90 days safety and tolerability of EFI/ACT-385781A will closely be monitored in all treated patients. This 90 follow-up will provide clinical evidence on the safety, tolerability, efficacy and treatment satisfaction of switching from Flolan® to EFI/ACT-385781A in patients with pulmonary arterial hypertension.

NCT ID: NCT01431326 Completed - Hypertension Clinical Trials

Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

PTN_POPS
Start date: November 2011
Phase:
Study type: Observational

Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).

NCT ID: NCT01409122 Completed - Clinical trials for Pulmonary Hypertension

Safety, Tolerability, and PK Parameters of Sodium Nitrite Inhalation Solution in Healthy Subjects

Start date: July 2011
Phase: Phase 1
Study type: Interventional

This is a four-part study of the safety, tolerability, and PK profile of sodium nitrite inhalation solution (AIR001) of ascending multiple doses (Part A) and of escalating doses with steady-state sildenafil (Part B) to healthy male and female subjects, as well as assessment of the safety and tolerability of multiple doses of AIR001 to patients with pulmonary arterial hypertension (part C) with a single dose PK study of AIR001 utilizing three different nebulizers (Part D).

NCT ID: NCT01393795 Completed - Pain Clinical Trials

Qutenza®-Remodulin® in Pulmonary Arterial Hypertension Patients

Start date: August 2011
Phase: Phase 2
Study type: Interventional

The investigators hypothesise that pre-application of Qutenza® patches to the skin may reduce pain at the site of Remodulin® SC infusion (sited 1 to 2 weeks later at the site of Qutenza pre-application), in which case it would greatly improve the quality of life of the patients, and enable many more to continue with this treatment. It may also provide new information to support the use of Qutenza® patches for preventing and reducing pain produced by inflammation. The present study will explore the efficacy of single applications of Qutenza® (capsaicin 8% patch) in reducing site pain caused by continuous SC infusion of Remodulin®, in pulmonary arterial hypertension patients, as assessed by changes in subjective pain rating score and/or pain and sensory testing.

NCT ID: NCT01392469 Completed - Clinical trials for Pulmonary Arterial Hypertension

Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Participants

Start date: April 20, 2011
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT01391104 Completed - Clinical trials for Pulmonary Arterial Hypertension

Responsiveness of Exercise Tests in Pulmonary Arterial Hypertension

RESPONS
Start date: April 2009
Phase: N/A
Study type: Interventional

Pulmonary arterial hypertension (PAH) is characterized by the progressive increase in pulmonary vascular resistance leading to shortness of breath and exercise intolerance. Exercise capacity has been used as the primary endpoint in most recent randomized controlled trials evaluating PAH-specific therapies as it correlates with functional class and survival in PAH. Exercise test is commonly assessed by the six-minute walk test (6MWT). However, there is commonly some discrepancy between significant clinical improvement and minor changes (generally <10% from baseline) in 6WMT following therapy. Because important clinical decisions are based on patients' functional capacity, a reproducible and sensitive exercise test is needed in PAH. The aim of this study was to compare the reproducibility and the responsiveness of the 6MWT, the endurance shuttle walk test (ESWT) and the cycle endurance test (CET) following pharmacological therapy in this disease.

NCT ID: NCT01389206 Completed - Clinical trials for Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program

PAH QuERI Ext
Start date: June 1, 2011
Phase:
Study type: Observational [Patient Registry]

Knowledge Translation Program for the guidelines and evidence-based management of PAH patients

NCT ID: NCT01365585 Completed - Clinical trials for Pulmonary Arterial Hypertension

Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ≥20mg TID For The Treatment Of Pulmonary Arterial Hypertension

Start date: July 2011
Phase:
Study type: Observational

The objective of this observational study is to gain clinical insight on the actual use of sildenafil citrate (Revatio™) for the treatment of pulmonary arterial hypertension (PAH). The primary objective is to assess effectiveness and safety of sildenafil at doses ≥20mg three times daily for the treatment of PAH.

NCT ID: NCT01355380 Completed - Clinical trials for Pulmonary Arterial Hypertension

Efficacy of Ventavis Used in Real-life Setting.

SPHERA
Start date: August 5, 2010
Phase: N/A
Study type: Observational

This is a registry of patients diagnosed with pulmonary arterial hypertension, scheduled for treatment with Ventavis. Typical clinical measures and quality of life will be prospectively followed in 12 months period.

NCT ID: NCT01342952 Completed - Clinical trials for Hypertension, Pulmonary

Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529

Start date: June 21, 2011
Phase: Phase 2
Study type: Interventional

An open label, long term extension to Study AMB112529. All subjects may remain in the extension study for a minimum of six months. Beyond the six month period, subjects may continue in the extension study until one of the following conditions is met: the subject turns 18 years of age (when the subject can receive marketed product) the product is approved and available for use in the subject's age group, development for use in the paediatric population is discontinued. the subject decides he/she no longer wants to participate in the study, the investigator considers it is in the best interest of the subject to discontinue ambrisentan (e.g. for safety reasons). The primary objective is the long-term safety and tolerability of ambrisentan in the paediatric PAH population. Secondary objectives are all cause mortality and change from baseline in Study AMB112529 on efficacy parameters.