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NCT01811693 · ClinicalTrials.gov registry record · Phase 2

Field Administration of Stroke Therapy-Blood Pressure Lowering

A Phase 2 study, sponsored by University of California, Los Angeles.

Terminated
Registry status
Phase 2
Development phase
4
Enrollment target

NCT01811693: Clinical Trial Phase 2 study, sponsored by University of California, Los Angeles.

NCT01811693 is a Phase 2 study that was terminated before completion, run by University of California, Los Angeles. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01811693, a Phase 2 study, was terminated before completion, sponsored by University of California, Los Angeles.

TERMINATED
Registry status
Phase 2
Development phase
4 participants
Enrollment target

Study Summary

This is an open, pilot, dose-escalation study of glyceryl trinitrate (GTN, Nitroglycerin) administered by paramedics in the field within 2 hours of symptom onset to 45 severely hypertensive stroke patients. The primary objective of the study is to evaluate the feasibility, safety, and physiologic efficacy of field-initiated glyceryl trinitrate in achieving modest reduction of blood pressure. Patients with acute stroke will be identified in the field by paramedics who have received training in basic and advanced cardiac life support, stroke recognition, and specific procedures relevant to the proposed study. Physician-investigators will obtain informed consent for each subject for study entry after cellular phone contact with paramedics. Paramedics will initiate antihypertensive treatment by applying transdermal GTN patch in the first two dose-tiers, and administering a single sublingual GTN metered spray followed by application of the transdermal system in the last dose tier. The sites involved in the study will be emergency medical services rescue ambulances and 8 receiving Stroke Center hospitals in Orange County, California, USA.

Primary Outcome

The mean change in blood pressure was measured in the Emergency Department approximately 15 minutes after application of the treatment

Interventions

  • DRUG Glycerly Trinitrate

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2013-04
Est. Completion 2013-12-09
Phase Phase 2

Why NCT01811693 stopped before completion

NCT01811693 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which Glycerly Trinitrate is the first listed.

NCT01811693 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01811693 about?

NCT01811693 is a clinical study titled "Field Administration of Stroke Therapy-Blood Pressure Lowering". This is an open, pilot, dose-escalation study of glyceryl trinitrate (GTN, Nitroglycerin) administered by paramedics in the field within 2 hours of symptom onset to 45 severely hypertensive stroke patients. The primary objective of the study is to evaluate the feasibility, safety, and physiologic ef...

What is the current status of trial NCT01811693?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2013-04. Estimated completion is 2013-12-09.

What interventions are being tested in trial NCT01811693?

The interventions under investigation include: Glycerly Trinitrate (DRUG).

Who is sponsoring clinical trial NCT01811693?

This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01811693's enrollment target sits among peer trials

4 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT01811693, the US trial registry maintained by the National Library of Medicine. NCT01811693 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.