A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH

Date Added
July 6th, 2021
PRO Number
Pro00109809
Researcher
Rahul Argula

List of Studies


Keywords
Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

The purpose of this study is to evaluate the efficacy and safety of sotatercept treatment (plus background PAH therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH. The study is divided into a Screening Period (up to 4 weeks), Double-Blind Placebo-Controlled (DBPC) Treatment Period (24 weeks), a Long-Term Double-Blind (LTDB) Treatment Period (until last participant completes the DBPC treatment period, up to approximately 72 weeks), and a Follow-Up Period (at least 8 weeks). Approximately 284 research participants will participate in this study. These participants will be enrolled at approximately 191 clinical centers around the world.

Institution
MUSC
Recruitment Contact
Abigail Grady
(843) 792-2072
gradyabi@musc.edu

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose MK-5475 in Participants with Pulmonary Hypertension Associated with COPD

Date Added
November 24th, 2020
PRO Number
Pro00105459
Researcher
Rahul Argula

List of Studies


Keywords
Lung, Pulmonary
Summary

This study is testing MK-5475 in people with pulmonary hypertension (high blood pressure in the blood vessel of the lung) linked to COPD (a chronic lung disease where it is hard to breathe). You may be able to join Part 2 of this study if you have pulmonary hypertension linked to COPD, and you are at least 40 years old but not more than 80 years old. About 24 subjects will be in Part 2 of this research. People from Part 1 of this study may be allowed to enter Part 2.

Institution
MUSC
Recruitment Contact
Angel Darrow
(843) 792-8092
darrowa@musc.edu

An Open-Label Extension Study of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD)

Date Added
March 24th, 2020
PRO Number
Pro00097579
Researcher
Rahul Argula

List of Studies


Keywords
Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

The purpose of this study is to assess safety of the study drug, inhaled treprostinil, and the ability to tolerate long-term treatment with the study drug in patients with PH-COPD. The study will also evaluate the effectiveness of the study drug over long-term treatment. Inhaled treprostinil is a medication that will be given to you by a handheld inhalation device (study nebulizer) called the Tyvaso® Inhalation System. The study is estimated to last 2 to 3 years but could be much shorter or longer. Depending on the final number of subjects who participated in the RIN-PH-304 study, either approximately 136 or approximately 314 subjects may be eligible to participate in this study from the U.S. study centers.

Institution
MUSC
Recruitment Contact
April Rasberry
(843) 792-2375
rasberry@musc.edu

Pulmonary Hypertension Association Registry (PHAR)

Date Added
March 18th, 2020
PRO Number
Pro00097483
Researcher
Rahul Argula

List of Studies


Keywords
Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

The PHAR is a multicenter, prospective registry of newly evaluated patients at PHCCs in the United States who have either PAH or CTEPH. Baseline information will be collected at the time of initial evaluation at the PHCC (within six months of the initial outpatient PHCC visit) with follow-up data collected at approximately 6-month intervals. This study will determine how patients with PH are evaluated, tested, and treated, and will observe how well patients do. The goal of the project is to see if patients with PH are treated according to recommended guidelines and to see if there are certain factors which lead to better or worse outcomes in patients with PH. There is no intervention or study medication used and there is no limitation to how a patient is treated in this study.

Institution
MUSC
Recruitment Contact
April Rasberry
(843) 2375
rasberry@musc.edu

A Phase 3, Randomized, Placebo-controlled, Double-blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD)

Date Added
July 23rd, 2019
PRO Number
Pro00090282
Researcher
Rahul Argula

List of Studies


Keywords
Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

The purpose of this study is to evaluate the effectiveness of inhaled treprostinil in improving exercise ability in patients with PH (Pulmonary Hypertension) -COPD (Chronic Obstructive Pulmonary Disease) when compared to an inactive solution, or placebo. This is a 34-week study. Approximately 136 subjects will be enrolled at approximately 60 US centers in the Original Design. If the study is adapted to the Contingent Design, approximately 314 subjects will be enrolled at approximately 80 US centers.

Institution
MUSC
Recruitment Contact
Abbi Reed
(843) 792-1820
reedab@musc.edu

National Biological Sample and Data Repository for Pulmonary Arterial Hypertension

Date Added
October 18th, 2016
PRO Number
Pro00058433
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

Subjects with Pulmonary Arterial Hypertension (PAH) will be asked to have blood drawn at their standard of care visit. Children (11 years and older) and adults are eligible. This study is voluntary. Blood samples obtained and the associated blood products and clinical/genetic data will be in the research study for a minimum of five years.

Institution
MUSC
Recruitment Contact
Ashley Warden
843-792-4349
jonesash@musc.edu



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