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Sildenafil for Swimming-Induced Pulmonary Edema (SIPE) Prevention

NCT03686813 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-11-22

Study results available
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Summary

This trial is testing the effectiveness of a single oral dose of sildenafil (50 mg) taken 1 hour before a provocative event on the subsequent development of swimming-induced pulmonary edema.

Conditions

  • Edema, Pulmonary
  • Immersion
  • Diving

Interventions

DRUG

Sildenafil Citrate

Oral sildenafil, 50 mg

DRUG

Placebo Oral Tablet

Placebo

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Duke University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2021-10-29
Completion
2021-10-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03686813 on ClinicalTrials.gov