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The Efficacy and Safety of Cleviprex in Ventriculostomy Patients Requiring IV Antihypertensive Therapy

NCT01042574 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-08-14

No results posted yet for this study

Summary

This study is a single-arm, open label protocol evaluating the use of Cleviprex to rapidly control hypertension in patients who present with intracerebral hemorrhage (ICH) or subarachnoid hemorrhage (SAH), and that require ICP monitoring via ventriculostomy (External Ventricular Drain or EVD).

Conditions

  • Hypertension
  • Intracranial Hemorrhage
  • Subarachnoid Hemorrhage

Interventions

DRUG

Clevidipine butyrate

Cleviprex will be administered according to current package insert instructions, with a starting dose of 2.0mg/hr for 1.5 minutes and thereafter titrated to lower blood pressure to a target goal of 110 mmHG to 140mmHG.

Sponsors & Collaborators

  • The Medicines Company

    collaborator INDUSTRY

  • Methodist Healthcare

    lead OTHER

Principal Investigators

  • Christopher K Finch, PharmD · Methodist Healthcare, University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01042574 on ClinicalTrials.gov