Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT00373360
Eligibility Criteria:
Inclusion Criteria:
* Age 18 to 70 years
* Diagnosis of Idiopathic or Familial Pulmonary Arterial Hypertension (PAH)or PAH associated with a collagen vascular disease or PAH associated with congenital systemic-to-pulmonary shunt repaired greater than 5 years prior to study entry or PAH associated with portal hypertension with mild or moderate hepatic dysfunction (Grade of A or B on the Child-Pugh Classification Scale)or PAH associated with drug or toxins or CTEPH
* WHO Class II-III
* Currently receiving intravenous epoprostenol therapy for at least three months and a stable dose for at least one month.
* Have central intravenous catheter
* Optimally treated with conventional pulmonary hypertension therapy and clinically stable for at least one month.
* Mentally and physically capable of learning to administer Remodulin using an intravenous infusion pump.
Exclusion Criteria:
* Nursing or pregnant woman
* Have any other type of PAH due to conditions other than noted in the above inclusion criteria, including but not limited to PAH related to thrombotic or embolic disease
* Have any other disease that is associated with pulmonary hypertension (e.g. sickle cell anemia, schistosomiasis)
* Changes to chronic PAH therapy (i.e., new therapy added within last 30 days\[including but not limited to oxygen, a different category of vasodilator, a diuretic, digoxin, bosentan, sildenafil\] or PAH medication discontinued within 7 days of study entry.
* Received any prostacyclin or prostacyclin analog except epoprostenol in the past 3 months.
* Central venous line infection within the past 30 days.
* Previous documented evidence of significant parenchymal lung disease
* Evidence or history of left-sided heart disease
* Musculoskeletal disorder or any other disease, which is thought to limit ambulation, or be connected to a machine that is not portable
* Uncontrolled hypertension, chronic renal insufficiency, or active infection.
* Use of investigational drug within past 30 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00373360
Study Brief:
Protocol Section:
NCT00373360