deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT04269408

A Safety and Efficacy Study of NicaPlant® in Aneurysmal Subarachnoid Haemorrhage Patients Undergoing Aneurysm Clipping

A Phase IIb: Randomised, Single-Blind, Safety, Tolerability, Efficacy and Pharmacokinetic Study of NicaPlant® in Aneurysmal Subarachnoid Haemorrhage Patients Undergoing Aneurysm Clipping

Sponsor: BIT Pharma GmbH

Conditions Aneurysmal Subarachnoid Hemorrhage
Interventions Nicardipine Standard of care
Updated 10 times since 2020 Last updated: Jul 11, 2023 Started: Apr 5, 2020 Primary completion: May 12, 2022 Completion: Jan 23, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Aneurysmal Subarachnoid Hemorrhage and is currently completed. BIT Pharma GmbH leads this study, which shows 10 recorded versions since 2020 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshotRecruiting~Apr 2020 – ~Aug 2020 · 4 months · monthly snapshotRecruiting~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshotRecruiting~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshotRecruiting~Sep 2021 – ~Apr 2022 · 7 months · monthly snapshotRecruiting~Apr 2022 – ~Sep 2022 · 5 months · monthly snapshotActive Not Recruiting~Sep 2022 – ~Aug 2023 · 11 months · monthly snapshotActive Not Recruiting~Aug 2023 – ~Jul 2024 · 11 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 23 months · monthly snapshotCompleted

Change History

10 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Aug 2023 — Jul 2024 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  4. Sep 2022 — Aug 2023 [monthly]

    Active Not Recruiting PHASE2

  5. Apr 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

▶ Show 5 earlier versions

  1. Sep 2021 — Apr 2022 [monthly]

    Recruiting PHASE2

  2. Jan 2021 — Sep 2021 [monthly]

    Recruiting PHASE2

  3. Aug 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

  4. Apr 2020 — Aug 2020 [monthly]

    Recruiting PHASE2

  5. Mar 2020 — Apr 2020 [monthly]

    Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • BIT Pharma GmbH
  • Data Magik Limited
  • NeuroScios GmbH
  • Pharm-Analyt Labor GmbH
Data source: BIT Pharma GmbH

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations