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NCT01966107 · ClinicalTrials.gov registry record · Phase 4

Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and Exacerbations in Moderate to Very Severe COPD Patients.

A Phase 4 study of Chronic Obstructive Pulmonary Disease and COPD, sponsored by AstraZeneca.

Completed
Registry status
Phase 4
Development phase
3,635
Enrollment target
20
Study locations

NCT01966107 is a Phase 4 study of Chronic Obstructive Pulmonary Disease and COPD that has completed, run by AstraZeneca. The registered enrollment target is 3,635 participants, above the 1,712-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (112% higher). The trial reports 20 study locations across 2 states.

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The verdict

NCT01966107, a Phase 4 study of Chronic Obstructive Pulmonary Disease and COPD, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 4
Development phase
3,635 participants
Enrollment target
20
Study locations

Study Summary

The Objectives of this study are to assess the safety of Aclidinium bromide on major adverse cardiovascular events (MACE), to assess the overall safety of Aclidinium bromide and to assess whether Aclidinium bromide reduces moderate or severe COPD exacerbations. This study is a double-blind, randomized, placebo controlled, parallel-group study to evaluate the effect of Aclidinium bromide on the cardiovascular safety and COPD exacerbations in patients with moderate to very severe COPD, as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.

Conditions Studied

Chronic Obstructive Pulmonary Disease COPD Moderate to Very Severe COPD

Interventions

  • DRUG Placebo
  • DRUG Aclidinium Bromide

Study Locations (20)

Alabama

  • Research Site - Birmingham
  • Research Site - Birmingham
  • Research Site - Birmingham
  • Research Site - Birmingham
  • Research Site - Birmingham
  • Research Site - Florence
  • Research Site - Foley
  • Research Site - Huntsville
  • Research Site - Jasper
  • Research Site - Mobile
  • Research Site - Tuscaloosa

Arizona

  • Research Site - Chandler
  • Research Site - Glendale
  • Research Site - Mesa
  • Research Site - Peoria
  • Research Site - Phoenix
  • Research Site - Phoenix
  • Research Site - Phoenix
  • Research Site - Phoenix
  • Research Site - Tucson

Trial Details

FieldValue
Enrollment Target 3,635 participants
Start Date 2013-10-16
Est. Completion 2017-09-21
Phase Phase 4

Sponsor

AstraZeneca

1,285 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01966107

The ClinicalTrials.gov registry entry for NCT01966107 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 3,635 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,712-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (112% higher). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Chronic Obstructive Pulmonary Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01966107 reports 20 study locations spanning 2 distinct geographic areas - top geographies include Alabama, Arizona.

Frequently Asked Questions

What is clinical trial NCT01966107 about?

NCT01966107 is a clinical study titled "Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and Exacerbations in Moderate to Very Severe COPD Patients.". The Objectives of this study are to assess the safety of Aclidinium bromide on major adverse cardiovascular events (MACE), to assess the overall safety of Aclidinium bromide and to assess whether Aclidinium bromide reduces moderate or severe COPD exacerbations. This study is a double-blind, randomiz...

What is the current status of trial NCT01966107?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 3,635 participants. The study started on 2013-10-16. Estimated completion is 2017-09-21.

What conditions does trial NCT01966107 study?

This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease, COPD, Moderate to Very Severe COPD.

What interventions are being tested in trial NCT01966107?

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

Who is sponsoring clinical trial NCT01966107?

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

Where is trial NCT01966107 being conducted?

This trial has 20 study locations across Alabama, Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.