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NCT03338998 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety and Tolerability of BAF312 Compared to Placebo in Patients With Intracerebral Hemorrhage (ICH).
A Phase 2 study of Hemorrhagic Stroke and Intracerebral Hemorrhage (ICH), sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 11
- Study locations
NCT03338998: Completed Phase 2 study of Hemorrhagic Stroke and Intracerebral Hemorrhage (ICH), sponsored by Novartis Pharmaceuticals.
NCT03338998 is a Phase 2 study of Hemorrhagic Stroke and Intracerebral Hemorrhage (ICH) that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 32 participants, below the 10,393-participant average among 6 other Hemorrhagic Stroke trials with a reported enrollment target (100% lower). The trial reports 11 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03338998, a Phase 2 study of Hemorrhagic Stroke and Intracerebral Hemorrhage (ICH), has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 11
- Study locations
Study Summary
This is a randomized, placebo-controlled, subject and investigator-blinded study to evaluate efficacy, safety and tolerability of BAF312 in participants with intracerebral hemorrhage (ICH)
Primary Outcome
Following the initial diagnostic CT, repeat CT images were obtained between 24-48 h after the diagnostic scan, and on Day 7 and Day 14 to capture the trajectory of PHE increase and plateau after ICH. Only non-contrast study CT scans were obtained on Day 7 and Day 14. The non-contrast scan acquired on each patient at first follow-up (i.e. 24-48 h after the diagnostic scan) served as the baseline for our analysis. All CT scans were uploaded through a secure server, and edema and hematoma volumes w
Conditions Studied
Interventions
- DRUG BAF312 solution
- DRUG Matching Placebo for BAF312 solution
- DRUG BAF312 tablet
- DRUG Matching Placebo for BAF312 tablet
Study Locations (11)
Texas
- Novartis Investigative Site - Houston
- Novartis Investigative Site - Houston
California
- Novartis Investigative Site - Palo Alto
Connecticut
- Novartis Investigative Site - New Haven
Georgia
- Novartis Investigative Site - Atlanta
Maryland
- Novartis Investigative Site - Baltimore
Michigan
- Novartis Investigative Site - Detroit
Ohio
- Novartis Investigative Site - Cincinnati
Oregon
- Novartis Investigative Site - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2017-12-24 |
| Est. Completion | 2020-05-13 |
| Phase | Phase 2 |
What the finished NCT03338998 record still lists
NCT03338998 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 10,393-participant average among 6 other Hemorrhagic Stroke trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Hemorrhagic Stroke appearing as the primary indexed condition, and to 4 interventions - of which BAF312 solution is the first listed.
NCT03338998 lists 11 locations in 10 states (Texas, California, Connecticut).
Frequently Asked Questions
What is clinical trial NCT03338998 about?
NCT03338998 is a clinical study titled "Efficacy, Safety and Tolerability of BAF312 Compared to Placebo in Patients With Intracerebral Hemorrhage (ICH).". This is a randomized, placebo-controlled, subject and investigator-blinded study to evaluate efficacy, safety and tolerability of BAF312 in participants with intracerebral hemorrhage (ICH)
What is the current status of trial NCT03338998?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2017-12-24. Estimated completion is 2020-05-13.
What conditions does trial NCT03338998 study?
This clinical trial studies the following conditions: Hemorrhagic Stroke, Intracerebral Hemorrhage (ICH).
What interventions are being tested in trial NCT03338998?
The interventions under investigation include: BAF312 solution (DRUG), Matching Placebo for BAF312 solution (DRUG), BAF312 tablet (DRUG), Matching Placebo for BAF312 tablet (DRUG).
Who is sponsoring clinical trial NCT03338998?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03338998 being conducted?
This trial has 11 study locations across California, Connecticut, Georgia, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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