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NCT00877383 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease

A Phase 3 study of Chronic Obstructive Pulmonary Disease (COPD), sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
1,142
Enrollment target
20
Study locations

NCT00877383 is a Phase 3 study of Chronic Obstructive Pulmonary Disease (COPD) that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,142 participants, above the 619-participant average among 36 other Chronic Obstructive Pulmonary Disease (COPD) trials with a reported enrollment target (84% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT00877383, a Phase 3 study of Chronic Obstructive Pulmonary Disease (COPD), has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
1,142 participants
Enrollment target
20
Study locations

Study Summary

This study assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD).

Interventions

  • DRUG Placebo to indacaterol
  • DRUG Indacaterol 150 μg
  • DRUG Tiotropium 18 μg

Study Locations (20)

California

  • Novartis Investigator Site - Buena Park
  • Novartis Investigator Site - Fullerton
  • Novartis Investigator Site - Mission Viejo
  • Novartis Investigator Site - San Ramon
  • Novartis Investigator Site - Santa Barbara
  • Novartis Investigator Site - Sepulveda
  • Novartis Investigator Site - Spring Valley
  • Novartis Investigator Site - Torrance
  • Novartis Investigator Site - Torrance
  • Novartis Investigator Site - Vista

Alabama

  • Novartis Investigator Site - Anniston
  • Novartis Investigator Site - Birmingham
  • Novartis Investigator Site - Jasper
  • Novartis Investigator Site - Mobile

Arizona

  • Novartis Investigator Site - Glendale
  • Novartis Investigator Site - Phoenix
  • Novartis Investigator Site - Phoenix
  • Novartis Investigator Site - Scottsdale

Arkansas

  • Novartis Investigator Site - Little Rock

Colorado

  • Novartis Investigator Site - Boulder

Trial Details

FieldValue
Enrollment Target 1,142 participants
Start Date 2009-04
Est. Completion 2010-02
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT00877383

The ClinicalTrials.gov registry entry for NCT00877383 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,142 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 619-participant average among 36 other Chronic Obstructive Pulmonary Disease (COPD) trials with a reported enrollment target (84% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Obstructive Pulmonary Disease (COPD) appearing as the primary indexed condition, and to 3 interventions - of which Placebo to indacaterol is the first listed.

NCT00877383 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Alabama, Arizona.

Frequently Asked Questions

What is clinical trial NCT00877383 about?

NCT00877383 is a clinical study titled "Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease". This study assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD).

What is the current status of trial NCT00877383?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,142 participants. The study started on 2009-04. Estimated completion is 2010-02.

What conditions does trial NCT00877383 study?

This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease (COPD).

What interventions are being tested in trial NCT00877383?

The interventions under investigation include: Placebo to indacaterol (DRUG), Indacaterol 150 μg (DRUG), Tiotropium 18 μg (DRUG).

Who is sponsoring clinical trial NCT00877383?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00877383 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. 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.