A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M

nited Therapeutics Corporation0 个研究点目标入组 6 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•1. The subject is between the ages of 12 and 75 years of age at Screening.
•2. The subject weighs a minimum of 40 kilograms with a Body Mass Index (BMI) less than 40kg/m2 at Screening.
•3. The subject, if female, is physiologically incapable of childbearing or practicing an acceptable method of birth control. For women of childbearing potential, a negative serum pregnancy test will be required at Screening.
•4. The subject has a diagnosis of symptomatic Idiopathic or Familial PAH (including PAH associated with appetite suppressant/toxin use), PAH associated with repaired congenital systemic-to-pulmonary shunts (repaired >= 5 years), PAH associated with Collagen Vascular Disease, or PAH associated with HIV.
•5. The subject, if HIV positive, has a CD4 lymphocyte count >= 200 within 30 days of Baseline and is receiving current standard of care anti-retroviral or other effective medication for treatment of HIV.
•6. The subject must have a Baseline 6-Minute Walk distance of between 200 and 400 meters, inclusive.
•7. The subject may benefit from the introduction of therapy (e.g. a prostacyclin) as determined by their medical provider.
•8. The subject must be optimally treated with conventional pulmonary hypertension therapy.
•9. The subject will voluntarily give informed consent to participate in the study.

•1. The subject is pregnant or lactating.
•2. The subject has previously received a prostacyclin, endothelin receptor antagonist, or phosphodiesterase-5 inhibitor within 30 days of Baseline.
•3. The subject has had a new type of chronic therapy for pulmonary hypertension added within 14 days of Baseline.
•4. The subject has had any PAH medication except for anticoagulants discontinued within 14 days of Baseline.
•5. The subject has any disease associated with pulmonary arterial hypertension other than mentioned in the inclusion criteria.
•6. The subject has a current diagnosis of uncontrolled sleep apnea.
•7. The subject has chronic renal insufficiency.
•8. The subject has anemia.
•9. The subject has a history or current evidence of left-sided heart disease
•10. The subject has significant parenchymal lung diseasea.
•11. The subject has uncontrolled systemic hypertension.
•12. The subject has any disease that is likely to limit ambulation.
•13. The subject is participating, or has participated in another investigational drug or device study within 30 days prior to Screening.

发起方

nited Therapeutics Corporation