Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Riociguat for Chronic...
HypertensionPulmonaryThis local, prospective, non-interventional, multi-center study includes patients treated with Riociguat for inoperable CTEPH(Chronic thromboembolic pulmonary hypertension)/ persistent or recurrent CTEPH after surgical treatment. It is planned to include a total of 400 patients (valid for safety analysis). This study is performed as an all-case investigation. The treatment of Riociguat is performed based on the product label in Japan. The standard observation period is 12 months from the 1st treatment of Riociguat. Safety and effectiveness are evaluated at 4th and 12th month. In addition, the extension observation is carried out once a year for 7 years at the longest to collect information on safety and effectiveness as long as Riociguat treatment continues. When the treatment of Riociguat is terminated, observation of a patient ends. For each patient, the investigator records data as defined in the protocol at each evaluation point by using the Electronic Data Capture (EDC) system. The duration of the study is approximately 9 years from launch.
Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure
Heart FailurePulmonary HypertensionThis study is a multi-center, prospective, randomized, double blind, placebo-controlled clinical trial. Subjects in the study will be adults with New York Heart Association (NYHA) Class II-IV heart failure (HF) due to left ventricular systolic dysfunction (LVSD), left ventricular ejection fraction (LVEF) <0.40, and secondary pulmonary hypertension (PH). The purpose of the study is to evaluate the safety, effectiveness, and effects of tadalafil compared to placebo on the subjects' functional capacity / quality of life.
Efficacy and Safety of Riociguat in Patients With Symptomatic Pulmonary Hypertension (PH) Associated...
Idiopathic Interstitial Pneumonias / Hypertension,PulmonaryTo evaluate the efficacy and safety of 26-weeks of treatment with riociguat vs. placebo in patients with symptomatic PH (pulmonary hypertension) associated with IIP (idiopathic interstitial pneumonias).
A Open Label Study to Assess the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects...
HypertensionThis is an open label, long term extension to Study AMB115811. All subjects may remain in the extension study for a minimum of 18 months. Beyond the 18-month period, subjects may continue in the extension study until one of the following: the product is approved locally for use in inoperable CTEPH patients; development for use in the CTEPH population is discontinued or product is not approved by the local regulatory authorities; or the investigator decides to discontinue the subject or subject decides to discontinue from the study. The primary purpose of this study is to provide clinically relevant information on the long term safety of ambrisentan in subjects with inoperable CTEPH.
Effects of Ventavis in Patients With Pulmonary Hypertension (PH) Secondary to Chronic Obstructive...
Chronic Obstructive Pulmonary DiseasePulmonary HypertensionThis is a phase 2, Multi-center, double-blind, randomized, placebo-controlled study to evaluate the effects of inhaled Iloprost in patients with pulmonary hypertension secondary to COPD. The main objective is to investigate the effect of iloprost on exercise endurance time during constant work rate cardiopulmonary exercise testing. Other efficacy and safety endpoints will additionally be analyzed.
Inhaled Prostaglandin E1 (IPGE1) for Hypoxemic Respiratory Failure (NHRF)
PrematurityRespiratory Insufficiency3 moreThis is a randomized controlled trial (RCT) on the use of Inhaled prostaglandin E1 (IPGE1) in Neonatal Hypoxemic Respiratory Failure (NHRF). Fifty patients recruited at 10 high volume sites within the NICHD Neonatal Research Network will constitute a pilot sample to evaluate the feasibility and safety of prolonged IPGE1 administration and determination of optimal dose. In this Pilot RCT, two doses of IPGE1 (300 and 150 ng/kg/min) will be administered over a maximum duration of 72 hours and compared with placebo. Once feasibility and safety of IPGE1 administered over 72 hours has been demonstrated in the pilot trial, a full scale randomized controlled trial will be planned.
Rapid Switch From Flolan to Remodulin in the Outpatient Clinic
HypertensionPulmonaryThe purpose of this 8-week study is to compare the effects of switching from therapy with epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing to Remodulin will have on patient satisfaction with their treatment and impact on quality of life.
Vasopressin and Inhaled Prostacyclin in Pediatric Pulmonary Hypertension
Pulmonary HypertensionTo diagnose pulmonary hypertension, children have a cardiac catheterization to check the blood pressure in their lungs. Children with pulmonary hypertension have high blood pressure in their lungs. The right ventricle of the heart has to do more work to pump against this higher pressure. The investigators do not know the best medicine(s) to help children with pulmonary hypertension when their right ventricles fail. The purpose of the study is to look at the effects of two different medicines on the blood pressure in the lungs of a child with pulmonary hypertension. The investigators hope to then be able to choose the best medicine for children with pulmonary hypertension and right ventricular failure. The first medicine is called vasopressin. It is a hormone that your body makes on its own. The investigators will be giving it through an intravenous infusion. The investigators think that vasopressin works differently in different parts of your body. The investigators are looking to see the different effects that vasopressin has in the lungs compared to the rest of the body. The second medicine is called prostacyclin and is something that your body also makes by itself. Prostacyclin, given via an intravenous infusion, is a treatment for pulmonary hypertension as it decreases pressure in the blood vessels. In the catheterization laboratory, patients breathe in this medicine to measure specific changes in the blood pressure in their lungs.
Inhaled Iloprost for the Treatment of Persistent Pulmonary Hypertension in the Term and Near Term...
Pulmonary HypertensionInhaled Iloprost will be administered to near term infants with Persistent Pulmonary Hypertension of the Newborn in two different doses in order to test safety and efficacy in reducing pulmonary artery pressure.
The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting
Pulmonary HypertensionA Comparison of Safety and Inhalation Times of Ventavis (iloprost) Inhalation Solution delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 "Power 15 Study"