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NCT03785678 · ClinicalTrials.gov registry record · Phase 3
Tenecteplase in Stroke Patients Between 4.5 and 24 Hours
A Phase 3 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 3
- Development phase
- 458
- Enrollment target
NCT03785678 is a Phase 3 study that has completed, run by Genentech. The registered enrollment target is 458 participants.
The verdict
NCT03785678, a Phase 3 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 458 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy and safety of tenecteplase compared with placebo in participants with acute ischemic stroke (AIS). All participants will receive standard-of-care therapy according to AmericanHeart Association/American Stroke Association clinical guidelines (2018). To determine eligibility for randomization, all participants will undergo multimodal CT or MRI at baseline. Only participants with a vessel occlusion (ICA or MCA M1/M2) and penumbral tissue will be randomized. The primary analysis is to compare the efficacy of tenecteplase versus placebo in all participants at Day 90.
Interventions
- OTHER Placebo
- BIOLOGICAL Tenecteplase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 458 participants |
| Start Date | 2019-03-02 |
| Est. Completion | 2023-02-28 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03785678
The ClinicalTrials.gov registry entry for NCT03785678 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 458 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03785678 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03785678 about?
NCT03785678 is a clinical study titled "Tenecteplase in Stroke Patients Between 4.5 and 24 Hours". This study will evaluate the efficacy and safety of tenecteplase compared with placebo in participants with acute ischemic stroke (AIS). All participants will receive standard-of-care therapy according to AmericanHeart Association/American Stroke Association clinical guidelines (2018). To determine...
What is the current status of trial NCT03785678?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 458 participants. The study started on 2019-03-02. Estimated completion is 2023-02-28.
What interventions are being tested in trial NCT03785678?
The interventions under investigation include: Placebo (OTHER), Tenecteplase (BIOLOGICAL).
Who is sponsoring clinical trial NCT03785678?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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