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Water and Sudafed in Autonomic Failure

NCT02149901 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-05-05

No results posted yet for this study

Summary

The specific aim of this study is to determine whether water ingestion potentiates the pressor response to pseudoephedrine in patients with primary disorders of autonomic failure. The study design will enable us to also evaluate the pressor response to water alone and to pseudoephedrine alone. In a secondary analysis, we will compare the results in patients with two autonomic disorders, pure autonomic failure (PAF) and multiple system atrophy (MSA). We hypothesize that drinking water following a dose of pseudoephedrine will lead to a greater increase in blood pressure than pseudoephedrine alone.

Conditions

Interventions

DRUG

Pseudoephedrine + 480 ml water

30 mg pseudoephedrine to be given with a pressor dose (480 ml) of drinking water

DRUG

Pseudoephedrine + 50 ml water

Pseudoephedrine given with a non-pressor (50 ml) dose of drinking water

OTHER

Placebo + 480 ml water (optional)

placebo PO with a pressor (480 ml) dose of drinking water

OTHER

Placebo + 50 ml water (optional)

placebo PO with a non-pressor (50 ml) dose of drinking water

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Emily M Garland, PhD, MSCI · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2020-12-31
Completion
2020-12-31

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 NCT02149901 on ClinicalTrials.gov