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NCT00624286 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study, sponsored by Novartis.

Completed
Registry status
Phase 3
Development phase
416
Enrollment target

NCT00624286: Completed Phase 3 study, sponsored by Novartis.

NCT00624286 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 416 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

NCT00624286, a Phase 3 study, has completed, sponsored by Novartis.

COMPLETED
Registry status
Phase 3
Development phase
416 participants
Enrollment target

Study Summary

This study was designed to provide 12 weeks efficacy and safety data of the 150 μg once-daily (od) dose of indacaterol in chronic obstructive pulmonary disease (COPD).

Primary Outcome

FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.

Interventions

  • DRUG Placebo to indacaterol
  • DRUG Indacaterol 150 μg

Trial Details

FieldValue
Enrollment Target 416 participants
Start Date 2008-02
Est. Completion 2008-07
Phase Phase 3
Novartis

265 total trials

What the finished NCT00624286 record still lists

NCT00624286 is an interventional study that assigns participants to a tested intervention. The registered 416 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 to indacaterol is the first listed.

NCT00624286 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00624286 about?

NCT00624286 is a clinical study titled "Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)". This study was designed to provide 12 weeks efficacy and safety data of the 150 μg once-daily (od) dose of indacaterol in chronic obstructive pulmonary disease (COPD).

What is the current status of trial NCT00624286?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 416 participants. The study started on 2008-02. Estimated completion is 2008-07.

What interventions are being tested in trial NCT00624286?

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

Who is sponsoring clinical trial NCT00624286?

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

How this trial's enrollment target compares

Where NCT00624286's enrollment target sits among peer trials

416 902nd of 2000 higher than 1,098 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 NCT00624286, the US trial registry maintained by the National Library of Medicine. NCT00624286 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.