To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH.

Phase 1

• Conditions: Pulmonary arterial hypertension; MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-002796-18-ES
• Lead Sponsor: Bial - Portela & Ca, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-16
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1. Have completed MPV3 of the preceding study BIA-51058-201.
2. Able to comprehend and willing to sign an informed consent form
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 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Significant non-compliance with the protocol during the preceding study BIA-51058-201 which may have an impact on this extension study.
2. WHO functional class IV as judged by the investigator.
3. Persistent hypotension defined as systolic blood pressure (SBP) < 95 mmHg or diastolic blood pressure (DBP) < 50 mmHg.
4. Uncontrolled diabetes mellitus.
5. Occurrence of an AE during the preceding study which is judged by the investigator as contraindicative to further participation in the extension study.
6. Any disease known to cause pulmonary hypertension other than PAH WHO Group 1, e.g. obstructive lung diseases, parasitic disease affecting the pulmonary system, sickle cell anaemia, left heart disease.
7. History of moderate to severe hepatic impairment (Child-Pugh B and C).
8. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (measured at V1).
9. Use of the following prohibited medication or treatments during study participation:
calcium channel blockers (CCBs) if used for the treatment of PAH in vasoreactive patients; drugs containing a catechol group that is metabolised by DßH (e.g. rimiterole, isoprenaline, dopamine, dopexamine or dobutamide) or a- and/or ß-blockers.
10. Presence of any other significant or progressive/unstable medical condition that, in the opinion of the investigator, would compromise evaluation of the study treatment or may jeopardise the patient’s safety, compliance or adherence to protocol requirements.
11. For women: Pregnancy or breast-feeding. Women of childbearing potential unable or unwilling to undergo pregnancy tests and practice acceptable contraceptive measures. Acceptable methods for women are surgical intervention (e.g. bilateral tubal occlusion), intrauterine device, double-barrier methods and true sexual abstinence (i.e. when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
12. Concurrent participation in any other drug investigational study, except BIA-51058-201.
13. Vulnerable patients according to Section 1.61 of the ICH guideline for Good Clinical Practice E6.

Study & Design

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