A Multi-center, open-label, multiple dose, dose finding study exploring the safety and tolerability of Beraprost Sodium Modified Release in PAH patients

• Conditions: Pulmonary Arterial Hypertension; MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension

• Registration Number: EUCTR2008-003290-41-IE
• Lead Sponsor: ungRx

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

A PAH patient must meet all of the following criteria:
1) Is male or female between the ages of 18 and 75 years of age, inclusive;

2) Has idiopathic or familial PAH, PAH associated with collagen vascular disease, or PAH induced by anorexigens;

3) Is clinically stable, as determined by the Investigator

4) Has previously undergone a cardiac catheterization which is consistent with PAH, specifically PAPm = 25mmHg (at rest), PCWP (or left ventricular end diastolic pressure) = 15mmHg, and PVR > 3 wood units;

5) Has been on a course of an endothelial receptor antagonist (ERA) or phosphodiesterase inhibitor (PDE-5) or the combination for at least 90 days at the time of the Baseline visit;

6) Has an unencouraged six-minute walk distance (6MWD) between 300 and 600 meters at the screening visit;

7) Is able to communicate effectively with study personnel;

8) Is considered to be reliable, willing, cooperative and compliant with the study protocol requirements;

9) Provides voluntary, written informed consent before participating in the study;

10) Is, if female, physiologically incapable of childbearing or is practicing an acceptable method of birth control (i.e. surgical sterilization, approved hormonal contraceptives, barrier methods [ such as a condom or diaphragm] used with spemicide, or an intrauterine device).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any Patient who meets any of the following criteria will be excluded from the study:
1) Has pulmonary venous hypertension, pulmonary veno-occlusive disease, Pulmonary capillary hemangiomatosis , severe chronic obstructive pulmonary disease, pulmonary hypertension related to congenital heart disease, or chronic thromboembolic pulmonary hypertension;

2) Is pregnant or lactating;

3) Has a known intolerance to beraprost sodium or prostanoids;

4) Has a pre-existing condition that could interfere with the absorption, distribution, metabolism, or excretion of drugs;

5) Current use of tobacco products;

6) Known history of syncope

7) Has, in the opinion of the Investigator, any concomitant disease other than those accepted as part of the inclusion criteria that would compromise the patient or the study;

8) Has had a change in or discontinued any PAH medication (with the exception of anticoagulants) within 30 days prior to the Baseline visit;

9) Has received any prostanoid therapy within 30 days prior to the Baseline visit or be scheduled to receive additional prostanoid therapy during the study except for acute vasodilstory testing;

10) Has received any investigational medication within 30 days prior to the Baseline visit or be scheduled to receive another investigational drug during the course of this study;

11) In the opinion of the investigator, may be unable to comply with the study protocol;

12) Has any pre exisiting disease known to cause pulmonary hypertension (e.g. obstructive lung disease, parasitic disease affecting the pulmonary system, sickle cell anemia, mitral valve stenosis, portal hypertension) other than those listed in the inclusion criteria;

13) Has donated blood or plasma or has lost a volume of blood > 450mL within six weeks prior to the Baseline visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the maximum tolerated dose (MTD) of BPS-MR in pulmonary arterial hypertension (PAH) patients, following chronic, twice daily administration.;Secondary Objective: Safety (adverse events, physical exam, vital signs, tolerability to BPS-MR, clinical laboratory parameters, electrocardiogram findings).<br><br>Patients pharmacokinetics parameters at MTD, including estimates of AUC8, <br>AUC0-12, Cmax, tmax, t1/2, CL/F and Vz/F.;Primary end point(s): The objective of this study is to determine the maximun tolerated dose (MTD) of BPS-MR in pulmonary arterial hypertension (PAH) patients, following chronic, twice-daily administration.