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NCT00856661 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-4)
A Phase 3 study, sponsored by H. Lundbeck A/S.
- Terminated
- Registry status
- Phase 3
- Development phase
- 270
- Enrollment target
NCT00856661: Clinical Trial Phase 3 study, sponsored by H. Lundbeck A/S.
NCT00856661 is a Phase 3 study that was terminated before completion, run by H. Lundbeck A/S. The registered enrollment target is 270 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00856661, a Phase 3 study, was terminated before completion, sponsored by H. Lundbeck A/S.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 270 participants
- Enrollment target
Study Summary
The purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3 to 9 hours from onset of stroke symptoms.
Primary Outcome
The mRS is a clinician-rated scale designed to provide a global assessment of the patients dependency after stroke. The scale consists of a single item measuring the patient's function based on the ability to perform daily activities. The patient is rated on a 7-point scale from 0 to 6, where a score of 5 corresponds to severe disability, and 6 to death. Assessment of a pre-stroke mRS score is based on an interview addressing the status of the patient prior to the stroke
Interventions
- DRUG Placebo
- DRUG Desmoteplase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2009-04 |
| Phase | Phase 3 |
Why NCT00856661 stopped before completion
NCT00856661 is an interventional study that assigns participants to a tested intervention. The registered 270 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00856661 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00856661 about?
NCT00856661 is a clinical study titled "Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-4)". The purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3 to 9 hours from onset of stroke symptoms.
What is the current status of trial NCT00856661?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 270 participants. The study started on 2009-04.
What interventions are being tested in trial NCT00856661?
The interventions under investigation include: Placebo (DRUG), Desmoteplase (DRUG).
Who is sponsoring clinical trial NCT00856661?
This trial is sponsored by H. Lundbeck A/S, which has 72 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00856661's enrollment target sits among peer trials
270 1217th of 2000 higher than 781 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
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