CompletedPhase 2

Safety and Efficacy of BIA 5-1058 in PAH

Austria, Germany, Italy20 participantsStarted 2019-06-26

Plain-language summary

This study aims to assess the safety and tolerability of the individual highest tolerated zamicastat doses, achieved in the study BIA-51058-201, during long-term treatment in Pulmonary Arterial Hypertension (PAH) disease.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: For inclusion in the extension study, patients had to fulfil all of the following criteria at visit V1 (Day 1, start of the extension study): * Have performed MPV3 of the preceding study BIA-51058-201. * Able to comprehend and willing to sign an informed consent form (ICF). * For women: Agreed not to donate ova from the time of informed consent until 30 days after the last IMP intake. * For men: Agreed not to donate sperm from the time of informed consent until 90 days after the last IMP intake Exclusion Criteria: Patients were to be excluded for any one of the following reasons: * Significant non-compliance with the protocol during the preceding study BIA-51058-201 which may have an impact on this extension study. * WHO functional class IV as judged by the investigator (reference 1) * Two or more consecutive measurements of systolic blood pressure (SBP) \< 95 mmHg or diastolic blood pressure (DBP) \< 50 mmHg measured at visit V1. * Uncontrolled diabetes mellitus with HbA1c ≥ 8.5% within the last three months or at visit V1. * Occurrence of an AE during the preceding study which is judged by the investigator as contraindicative to further participation in the extension study. * Any disease known to cause pulmonary hypertension other than PAH WHO Group 1. * Obstructive lung disease: Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC) \< 60% and FEV1 \< 60% of predicted value after bronchodilator administration, as demonstrated and doc…

What they're measuring

Number of participants with adverse events (AEs)

Timeframe: Up to 12 weeks

Clinically relevant changes in laboratory parameters: coagulation

Timeframe: From baseline to week 6 and week 12, and from day -1 to week 6 and week 12

Incidence of clinically relevant changes (abnormalities) in laboratory parameters: biochemistry

Timeframe: From baseline to week 6 and week 12, and from day -1 to week 6 and week 12

Incidence of clinically relevant changes (abnormalities) in laboratory parameters: haematology

Timeframe: From baseline to week 6 and week 12, and from day -1 to week 6 and week 12

Clinically relevant changes in laboratory parameters: urinalysis

Timeframe: From baseline to week 6 and week 12, and from day -1 to week 6 and week 12

Clinically relevant changes in laboratory parameters: arterial blood gas

Timeframe: From baseline to week 12, and from day -1 to week 12

Clinically relevant changes in vital signs: blood pressure

Timeframe: From baseline to week 6 and week 12, and from day -1 to week 6 and week 12

Trial details

NCT IDNCT06009185

SponsorBial - Portela C S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-02-17

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