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A Safety and Efficacy Study of Blood Pressure Control in Acute Aortic Emergencies - A Pilot Study (PROMPT)

NCT01033370 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2018-08-27

No results posted yet for this study

Summary

This study is a single center, non-randomized, open-label, pilot efficacy and safety study evaluating the ability of clevidipine IV antihypertensive to rapidly control elevated blood pressure (BP) in the setting of an acute aortic emergencies (aneurysm, dissection or other aortic disease).

Conditions

  • Aortic Aneurysm
  • Aortic Disease

Interventions

DRUG

clevidipine.

Clevidipine administered per IV infusion, starting dose of 2 mg/h (4 mL/hr) for 3 minutes \& titrated to the desired BP lowering effect to SBP goal of \< 120 mmHg, max infusion rate may not exceed 32 mg/h (64 mL/hr).

Sponsors & Collaborators

  • The Medicines Company

    collaborator INDUSTRY

  • The Methodist Hospital Research Institute

    collaborator OTHER

  • Asma Zainab, M.D.

    lead OTHER

Principal Investigators

  • Faisal Masud, MD · The Methodist Hospital and The Methodist Hospital Research Institute

  • Asma Zainab, MD · The Methodist Hospital Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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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 NCT01033370 on ClinicalTrials.gov