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NCT00297115 · ClinicalTrials.gov registry record · Phase 3

Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125)

A Phase 3 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
1,568
Enrollment target

NCT00297115 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 1,568 participants.

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The verdict

NCT00297115, a Phase 3 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
1,568 participants
Enrollment target

Study Summary

The aim of the study is to compare the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will be up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast. For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).

Interventions

  • DRUG Placebo
  • DRUG Roflumilast

Trial Details

FieldValue
Enrollment Target 1,568 participants
Start Date 2006-03
Est. Completion 2008-08
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT00297115

The ClinicalTrials.gov registry entry for NCT00297115 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,568 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00297115 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00297115 about?

NCT00297115 is a clinical study titled "Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125)". The aim of the study is to compare the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will be up to 56 weeks. The ...

What is the current status of trial NCT00297115?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,568 participants. The study started on 2006-03. Estimated completion is 2008-08.

What interventions are being tested in trial NCT00297115?

The interventions under investigation include: Placebo (DRUG), Roflumilast (DRUG).

Who is sponsoring clinical trial NCT00297115?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

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

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.