Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 3 study, sponsored by University of Minnesota.
NCT01176565 is a Phase 3 study that was terminated before completion, run by University of Minnesota. The registered enrollment target is 1,000 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome was death or disability, defined by modified Rankin scale (mRS) of 4-6 at 90 days following treatment. The modified Rankin Scale score ranges from 0, indicating no symptoms, to 6, indicating death. A score of 4 indicates moderately severe disability including the inability to walk or attend to one's own bodily needs. A score of 5 indicates severe disability; bedridden, incontinent, and requiring constant nursing care. To score a 3 or lower on the mRS, a person must at least b
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 |
Why NCT01176565 stopped before completion
NCT01176565 is an interventional study that assigns participants to a tested intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% higher).
The record links to 0 conditions, and to 1 intervention - of which Intravenous nicardipine hydrochloride is the first listed.
NCT01176565 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01176565's enrollment target sits among peer trials
1,000 296th of 2000 higher than 1,689 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00018044 · 1,000 participants
Study of Mycobacterial Infections
- NCT01036581 · 1,000 participants · NA
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
- NCT01192048 · 1,000 participants
Genetics of Congenital Heart Disease
- NCT01553214 · 1,000 participants · Phase 4
Improving White Blood Cell Collection From Healthy Donors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI