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Clinical Trial 9542

Pittsburgh, PA 15213

Study Summary:

FREEDOM: Studies for patients with pulmonary arterial hypertension

About the studies
Pulmonary arterial hypertension (PAH) is a rare and debilitating condition that causes high blood pressure in lung blood vessels. Symptoms may include shortness of breath, tiredness, chest pain, and a rapid heartbeat. As the disease progresses, it can lead to heart failure and death. Thanks to ongoing clinical research, management of the disease has improved over the years.

The FREEDOM studies are Phase III clinical research studies investigating the safety and efficacy of an oral prostanoid, UT-15C (treprostinil diethanolamine) sustained-release tablets, in patients with PAH. UT-15C SR may offer an additional treatment option to patients with PAH, as it could be the first orally available sustained-release prostanoid of its kind.

About the study drug
Currently available prostanoid therapies are administered by inhalation or given to patients through an IV or subcutaneous infusion, which may be difficult for some patients to manage. The drug being evaluated in the FREEDOM studies, UT-15C SR, is an oral, sustained-release prostanoid that may help in the treatment of PAH. The sustained-release formulation of the drug increases the time the drug is available to the body, which may result in less frequent dosing.

Who can participate?
You may be eligible if you:

  • Are 12–75 years old
  • Have a confirmed diagnosis of PAH
What does the study involve?
Eligible study participants will be asked to:
  • Provide informed consent
  • Attend study visits
  • Receive the study drug orally
  • Undergo study-related physical exams
  • Speak with the study staff about your health and wellbeing
Participants will receive the study drug or placebo and may be eligible to continue to receive the study medication in an open-label extension study. Participants in the FREEDOM studies will be reimbursed for all reasonable travel expenses, and study coordinators will assist individuals with travel arrangements to ensure that all participants are able to safely and conveniently travel to a PAH study site. drupal analytics

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.