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NCT00644449 · ClinicalTrials.gov registry record · Phase 3

A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Acute Symptoms of Chronic Bronchitis

A Phase 3 study, sponsored by Pfizer.

Completed
Registry status
Phase 3
Development phase
551
Enrollment target

NCT00644449: Completed Phase 3 study, sponsored by Pfizer.

NCT00644449 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 551 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00644449, a Phase 3 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 3
Development phase
551 participants
Enrollment target

Study Summary

This study was performed to confirm that a single 2.0-g dose of azithromycin SR is at least as effective as 7 days of levofloxacin 500 mg/day in adults with acute exacerbation of chronic bronchitis Secondary objectives: To assess safety and the bacteriologic efficacy of both treatment regimens

Interventions

  • OTHER placebo
  • DRUG levofloxacin
  • DRUG azithromycin SR (Zithromax; compound: CP-62,993)

Trial Details

FieldValue
Enrollment Target 551 participants
Start Date 2003-01
Est. Completion 2004-03
Phase Phase 3
Pfizer

1,845 total trials

What the finished NCT00644449 record still lists

NCT00644449 is an interventional study that assigns participants to a tested intervention. The registered 551 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 (29% lower).

The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.

NCT00644449 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00644449 about?

NCT00644449 is a clinical study titled "A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Acute Symptoms of Chronic Bronchitis". This study was performed to confirm that a single 2.0-g dose of azithromycin SR is at least as effective as 7 days of levofloxacin 500 mg/day in adults with acute exacerbation of chronic bronchitis Secondary objectives: To assess safety and the bacteriologic efficacy of both treatment regimens

What is the current status of trial NCT00644449?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 551 participants. The study started on 2003-01. Estimated completion is 2004-03.

What interventions are being tested in trial NCT00644449?

The interventions under investigation include: placebo (OTHER), levofloxacin (DRUG), azithromycin SR (Zithromax; compound: CP-62,993) (DRUG).

Who is sponsoring clinical trial NCT00644449?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00644449's enrollment target sits among peer trials

551 680th of 2000 higher than 1,321 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 NCT00644449, the US trial registry maintained by the National Library of Medicine. NCT00644449 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.