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NCT01176565 · ClinicalTrials.gov registry record · Phase 3
Antihypertensive Treatment of Acute Cerebral Hemorrhage-II
A Phase 3 study, sponsored by University of Minnesota.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,000
- Enrollment target
NCT01176565 is a Phase 3 study that was terminated before completion, run by University of Minnesota. The registered enrollment target is 1,000 participants.
The verdict
NCT01176565, a Phase 3 study, was terminated before completion, sponsored by University of Minnesota.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,000 participants
- Enrollment target
Study Summary
The specific aims of this study are to: 1. Definitively determine the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of patients with death and disability (mRS 4-6) at 3 months among subjects with ICH who are treated within 4.5 hours of symptom onset. 2. Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the subjects' quality of life as measured by EuroQol at 3 months. 3. Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of hematoma expansion (defined as increase from baseline hematoma volume of at least 33%) and in the change from baseline peri-hematoma volume at 24 hours on the serial computed tomographic (CT) scans. 4. Assess the safety of the intensive treatment relative to the standard treatment in the proportion of subjects with treatment-related serious adverse events (SAEs) within 72 hours.
Interventions
- DRUG Intravenous nicardipine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2011-05-15 |
| Est. Completion | 2016-03-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01176565
The ClinicalTrials.gov registry entry for NCT01176565 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Intravenous nicardipine hydrochloride is the first listed.
NCT01176565 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01176565 about?
NCT01176565 is a clinical study titled "Antihypertensive Treatment of Acute Cerebral Hemorrhage-II". The specific aims of this study are to: 1. Definitively determine the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of patients with death and disability (mRS 4-6) at 3 months among subjects with ICH who are treated within 4.5 hours of symptom o...
What is the current status of trial NCT01176565?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,000 participants. The study started on 2011-05-15. Estimated completion is 2016-03-08.
What interventions are being tested in trial NCT01176565?
The interventions under investigation include: Intravenous nicardipine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01176565?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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