E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pulmonary Arterial Hypertension |
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E.1.1.1 | Medical condition in easily understood language |
Pulmonary Arterial Hypertension |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10064911 |
E.1.2 | Term | Pulmonary arterial hypertension |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to assess the safety of long term treatment with BPS-MR tablets in eligible patients who participate in the BPS-MR-PAH-201 study. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective s are to describe the efficacy of BPS-MR tablets on an unencouraged 6 minute walk test (6MWT), the Borg Dyspnea Scale and clinical worsening in eligible patients who participate in the BPS-MR-PAH-201 study. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients who remained on study drug and completed all assessements during the treatment phase of study BPS-MR-PAH-201 are eligible for this study.
Female Patients must either be physiologically incapable of childbearing or be practicing acceptable method of birth control (e.g approved hormonal contraceptive, barrier method, such as condom or diaphragm, used with a spemicide, or an intrauterine device
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E.4 | Principal exclusion criteria |
Patients who discontinued study drug during the previous study (BPS-MR-PAH-201) for any reason (e.g. treatment related adverse event) are not eligible for entry into this study
Patients who are pregnant or lactating are excluded from participation in the open-label extension
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective is to assess the safety of long-term treatment with BPS-MR tablets in eligible patients who participated in the BPS-MR-PAH-201 study. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Endpoint will be assessed at all study visits: Baseline, 3,6 and 12 months and annual visits and during Month 9 and quarterly phone calls. |
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E.5.2 | Secondary end point(s) |
The secondary objectives are to describe the efficacy of BPS-MR tablets on an unencouraged 6-Minute Walk Test (6MWT), the Borg Dyspnea Scale and Clinical Worsening in eligible patients who participated in the BPS-MR-PAH-201 study. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Endpoint will be assessed at all study visits: Baseline, 3,6 and 12 months and annual visits |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |