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NCT06009185
Safety and Efficacy of BIA 5-1058 in PAH
Phase 2 trial testing Oral zamicastat in Pulmonary Arterial Hypertension in 20 participants. Completed in 17 February 2022.
17 February 2022
Quick facts
| Lead sponsor | Bial - Portela C S.A. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 26 June 2019 |
| Primary completion | 17 February 2022 |
| Estimated completion | 17 February 2022 |
| Sites | 11 locations across Italy, Austria, United Kingdom, Germany, Portugal, Spain |
Drugs / interventions tested
- Oral zamicastat — full drug profile →
Conditions studied
- Pulmonary Arterial Hypertension — all drugs for Pulmonary Arterial Hypertension →
Sponsor
Bial - Portela C S.A. — full company profile →
Who can join
Adults 18 to 70, any sex, with Pulmonary Arterial Hypertension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06009185
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Oral zamicastat
Trials testing the same drug.
- NCT04316143 — Pharmacokinetics, Safety and Efficacy of BIA 5-1058 in PAH (Zamicastat) · Phase 2 · completed
Other recruiting trials for Pulmonary Arterial Hypertension
Currently open trials in the same condition.
- NCT07391228 — Cognitive Alterations in Pulmonary Arterial Hypertension (PAH) · active not recruiting
- NCT06351345 — 129 Xenon Imaging in Patients Treated With Sotatercept · Phase 2 · recruiting
- NCT07217522 — Rutgers University Study of the Genetics of Pulmonary Hypertension · recruiting
- NCT07013149 — The Impact of ERA Switching on Risk Stratification in Pulmonary Arterial Hypertension · recruiting
- NCT06658522 — Right Ventricular Compensation With Sotatercept: A Prospective Single Arm Open Label Phase 4 Study to Evaluate the Effec · Phase 4 · recruiting
Other Bial - Portela C S.A. trials
Trials by the same sponsor.
- NCT07403799 — REal-life ON PARKinson's - ITaly (REONPARK-IT) · recruiting
- NCT04990284 — eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs. · Phase 4 · completed
- NCT04986995 — OpicApone Sleep dISorder · Phase 4 · completed
- NCT04978597 — Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe (EPSILON Study) · Phase 3 · completed
- NCT04986982 — OpiCapone Effect on Motor Fluctuations and pAiN · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06009185 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bial - Portela C S.A.
- Last refreshed: 1 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06009185.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing