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:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT01586156
Eligibility Criteria:
Inclusion Criteria:
* Men and women age 18 or older not greater than age 65 years
* Diagnosis of pulmonary arterial hypertension class 1, 3, 4, 5 (Dana Point 2008)
* NYHA (New York Health Association)/WHO (World Health Organization) Class I-III
* PAH medications must have been initiated according to the latest consensus statement recommendations and remained stable for the last 30 days
* Women of child-bearing age must use a double-barrier local contraception till completion of the study
* Subjects must demonstrate understanding of the study, sign the informed consent, and have a reliable method of communication for contact and ability to comply with the study requirements
Exclusion Criteria:
* Participation in any other treatment studies during enrollment
* Significant illness in the past 30 days requiring hospitalization
* Hepatic insufficiency (transaminase levels \> 4 fold the upper limit of normal or bilirubin \> 2 fold the upper limit of normal),
* History of HIV, Hepatitis B or C
* Serum creatinine \> 2.8 mg/dl
* Pregnancy, breast-feeding, or lack of safe contraception
* Acute decompensated heart failure within past 30 days
* Known allergy or intolerance to carvedilol or other β blockers
* Significant, persistent bradycardia (resting heart rate \< 50 bpm) or hypotension (systolic blood pressure \< 100 mmHg or mean blood pressure \< 70 mmHg) at the time of enrollment
* Second or third-degree AV (Atrial Ventricular) block without pacemaker
* Use of CYP2D6 isoenzyme inhibitors (such as quinidine, fluoxetine, paroxetine, propafenone) which increase drug levels and result in greater vasodilating effects and hypotension
* Use of hypotensive drugs that deplete catecholamines (such as reserpine and monoamine oxidase inhibitors) which may lead to greater signs of hypotension or bradycardia
* Other medical and psychosocial conditions as determined by principal investigator deemed unsuitable for enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01586156
Study Brief:
Protocol Section:
NCT01586156