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NCT01580501 · ClinicalTrials.gov registry record · Phase 1

PDE Inhibitors in DMD Study (Acute Dosing Study)

A Phase 1 study, sponsored by Cedars-Sinai Medical Center.

Completed
Registry status
Phase 1
Development phase
12
Enrollment target

NCT01580501 is a Phase 1 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 12 participants.

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The verdict

NCT01580501, a Phase 1 study, has completed, sponsored by Cedars-Sinai Medical Center.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

PDE5A inhibition, which boosts NO-cGMP signaling, will relieve functional muscle ischemia and restore normal blood flow regulation (i.e., functional sympatholysis) during exercise in boys with DMD. The investigators specific aim is to perform an efficient dose-titration study to inform the design of a randomized multicenter trial of PDE5A inhibition for clinical skeletal muscle and cardiac endpoints.

Interventions

  • DRUG Tadalafil and Sildenafil

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2012-03
Phase Phase 1

Sponsor

Cedars-Sinai Medical Center

339 total trials

What the Registry Record Tells You About NCT01580501

The ClinicalTrials.gov registry entry for NCT01580501 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Tadalafil and Sildenafil is the first listed.

NCT01580501 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01580501 about?

NCT01580501 is a clinical study titled "PDE Inhibitors in DMD Study (Acute Dosing Study)". PDE5A inhibition, which boosts NO-cGMP signaling, will relieve functional muscle ischemia and restore normal blood flow regulation (i.e., functional sympatholysis) during exercise in boys with DMD. The investigators specific aim is to perform an efficient dose-titration study to inform the design of...

What is the current status of trial NCT01580501?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2012-03.

What interventions are being tested in trial NCT01580501?

The interventions under investigation include: Tadalafil and Sildenafil (DRUG).

Who is sponsoring clinical trial NCT01580501?

This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.