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Diclofenac for Submassive PE

NCT01590342 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2017-09-06

No results posted yet for this study

Summary

The primary objective is to demonstrate the clinical benefits of diclofenac (added to standard anticoagulant therapy) over placebo in normotensive patients with acute symptomatic pulmonary embolism and right ventricular dysfunction.

The secondary objective is to assess the safety after administration of diclofenac in normotensive patients with acute symptomatic pulmonary embolism and right ventricular dysfunction.

Conditions

Interventions

DRUG

Diclofenac

Diclofenac 75 mg, two doses

DRUG

Placebo

Placebo, two doses

Sponsors & Collaborators

  • Ministry of Health, Spain

    lead OTHER_GOV

Principal Investigators

  • David Jimenez, MD, PhD · Ramon y Cajal Hospital, IRYCIS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2017-01-31
Completion
2017-06-30

Countries

  • Spain

Study Locations

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Entities

Drugs
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 NCT01590342 on ClinicalTrials.gov