None listed
Conditions
Interventions
Drug: JTT-251 50 mg
Type of group
1 dose consistent of 03 tablet for oral administration for 24 weeks starting at Visit 2, QD preferably in the morning, regardless of meals
Group name:dsdsa Type of group
1 dose consistent of 03 tablet for oral administration for 24 weeks starting at Visit 2, QD preferably in the morning, regardless of meals
Sponsors
Akros Pharma Inc.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female, age 18 to 80 years (inclusive), at the Screening Visit; 2. A clinical diagnosis of PAH as classified by idiopathic, heritable, drug and toxin-induced, congenital heart disease or associated with connective tissue disease [i.e., World Health Organization (WHO) Group 1 with exceptions]; 3. Participants must have a clinical diagnosis of PAH confirmed by right heart catheterization (RHC) at any time prior to the Screening Visit with results that are as follows: • Resting mean pulmonary arterial pressure (mPAP) >25 mmHg and • PVR >240 dyn·s/cm5 and • Pulmonary artery wedge pressure (PAWP) >15 mmHg or left ventricular end diastolic pressure (LVEDP) >15 mmHg; Note: If both PAWP and LVEDP are not available, participants must have less than 3 of the following left heart disease risk factors: a. Body mass index ≥30 kg/m2 b. History of essential hypertension c. Diabetes mellitus (any type) d. Historical evidence of significant coronary artery disease (CAD) established by any of the following: • History of myocardial infarction; • History of percutaneous coronary intervention; • Angiographic evidence of CAD (>50% stenosis in ≥1 vessel); • Previous coronary artery bypass grafting; • Stable angina. If 3 or more of the above left heart disease risk factors are present, the left atrial volume index must be 25 mmHg and • PVR > 400 dyn·s/cm5 and • PAWP 12 months without an alternative medical cause [regardless of follicle stimulating hormone (FSH) value] at the Screening Visit, or 2) Cessation of menstruation for 40 mIU/mL at the Screening Visit. All other females will be considered of childbearing potential and must either: a. practice abstinence, or b.
Exclusion criteria
Exclusion criteria: 1. Participants with PAH associated with portal hypertension, human immunodeficiency virus (HIV), schistosomiasis or sickle cell disease as well as participants with pulmonary parenchymal disease or thromboembolic disease; historical test results that rule out parenchymal lung disease and thromboembolic disease are acceptable; if no historical results are available, pulmonary function test(s) (see exclusion criteria #4 and 5) and either a ventilation-perfusion (V/Q) scan or pulmonary angiogram must be performed during the Screening Visit; 2. Participants with known significant left heart disease including: left ventricular dysfunction (i.e., left ventricular ejection fraction 3.0 × upper limit of normal (ULN) at the Screening Visit; 9. Participants with an absolute neutrophil count 100.4°F (38.0°C)] at Visit 2 prior to randomization; Note: Successfully treated infection(s) that required antibiotics will be permitted if resolved >7 days prior to Visit 2. 11. Participants with a history of malignancy of any organ system (other than localized basal or squamous cell carcinoma of the skin or cervical cancer in situ), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases; 12. Participants with a resting systolic blood pressure <90 mmHg at the Screening Visit; 13. Participants with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 using the 4-variable Modification of Diet in Renal Disease (MDRD) equation: eGFR (in mL/min/1.73 m2) = 175 < Serum Creatinine -1.154 x age -0.203 x 1.212 (if participant is black) X 0.742 (if female); 14. Participants who test positive for hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or HIV antibodies at the Screening Visit; Note: If a participant tests positive for anti-HCV antibodies, but has no history of HCV treatment, the participant may qualify for the study if the test result for HCV by polymerase chain reaction (PCR) is negative (i.e., HCV messenger ribonucleic acid [mRNA] <15 IU/mL). 15. Participants who are currently participating or have participated in a clinical study involving an investigational drug or device within 30 days, five half lives, or twice the duration of the biological effect of the investigational product, if known (whichever is longer) prior to the Screening Visit; 16. Participa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Right Heart Catheterization Measure:Efficacy parameter: Changes on PVR as assessed by RHC Timepoints:From baseline to EOT | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:6MWD Test is a non encouraged test that measures the distance walked by a participant over six minutes. Measure:Efficacy parameter: Changes on 6MWD Timepoints:From baseline to EOT ; Outcome name:The functional class is a measure of PAH severity according to the functional status of the participant and ranges from function class I to IV. Measure:Efficacy parameter: Changes on WHO functional class status Timepoints:From baseline to EOT ; Outcome name:change from baseline in safety laboratory, vital sign and electrocardiogram (ECG) parameters and AEs leading to permanent discontinuation of study drug Measure:Safety parameter: N adverse events (AEs), type and severity of AEs Timepoints:From baseline to EOT | — |
Countries
Argentina, Brazil, Chile, Colombia, Israel, Mexico, Peru, Russian Federation, United States
Contacts
Public ContactJuanita Aching
PPD Peru S.A.C.
Outcome results
None listed