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NCT00677807 · ClinicalTrials.gov registry record · Phase 3

Safety, Tolerability and Efficacy of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study, sponsored by Novartis.

Completed
Registry status
Phase 3
Development phase
415
Enrollment target

NCT00677807: Completed Phase 3 study, sponsored by Novartis.

NCT00677807 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 415 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00677807, a Phase 3 study, has completed, sponsored by Novartis.

COMPLETED
Registry status
Phase 3
Development phase
415 participants
Enrollment target

Study Summary

This study evaluated the 1 year safety, tolerability and efficacy of indacaterol against placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients

Primary Outcome

The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment. Low Pulse Rate was defined as a pulse rate: \<40 bpm or \<= to 50 bpm and a decrease from baseline \>= to 15 bpm. High Pulse Rate was defined as a pulse rate: \>130 bpm or \>= to 120 bpm and an increase from baseline \>= to 15 bpm.

Interventions

  • DRUG Placebo
  • DRUG Indacaterol

Trial Details

FieldValue
Enrollment Target 415 participants
Start Date 2008-05
Est. Completion 2009-03
Phase Phase 3
Novartis

265 total trials

What the finished NCT00677807 record still lists

NCT00677807 is an interventional study that assigns participants to a tested intervention. The registered 415 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower).

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

NCT00677807 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00677807 about?

NCT00677807 is a clinical study titled "Safety, Tolerability and Efficacy of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)". This study evaluated the 1 year safety, tolerability and efficacy of indacaterol against placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients

What is the current status of trial NCT00677807?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 415 participants. The study started on 2008-05. Estimated completion is 2009-03.

What interventions are being tested in trial NCT00677807?

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

Who is sponsoring clinical trial NCT00677807?

This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00677807's enrollment target sits among peer trials

415 903rd of 2000 higher than 1,096 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00677807, the US trial registry maintained by the National Library of Medicine. NCT00677807 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.