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NCT01715298 · ClinicalTrials.gov registry record · Phase 3

NVA237 BID Versus Placebo Twelve-week Efficacy Study

A Phase 3 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
432
Enrollment target

NCT01715298 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 432 participants.

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The verdict

NCT01715298, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
432 participants
Enrollment target

Study Summary

The study serves to determine whether the treatment of patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and safe. The efficacy and safety of the drug will be tested against a placebo treatment. The primary criterion to assess efficacy will be the difference between the serial lung function measurements of patients who have been treated for 12 weeks with NVA237 versus those that have received placebo treatment for 12 weeks. A serial lung function measurement (FEV1 testing) will be conducted and the "area under the curve" will be the measure for the ability to breathe.

Interventions

  • DRUG Placebo
  • DRUG NVA237

Trial Details

FieldValue
Enrollment Target 432 participants
Start Date 2012-11
Est. Completion 2013-12
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT01715298

The ClinicalTrials.gov registry entry for NCT01715298 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 432 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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

NCT01715298 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01715298 about?

NCT01715298 is a clinical study titled "NVA237 BID Versus Placebo Twelve-week Efficacy Study". The study serves to determine whether the treatment of patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and safe. The efficacy and safety of the drug will be tested against a placebo treatment. The primary criterion to a...

What is the current status of trial NCT01715298?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 432 participants. The study started on 2012-11. Estimated completion is 2013-12.

What interventions are being tested in trial NCT01715298?

The interventions under investigation include: Placebo (DRUG), NVA237 (DRUG).

Who is sponsoring clinical trial NCT01715298?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 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.