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NCT00625612 · ClinicalTrials.gov registry record · Phase 3

Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease

A Phase 3 study, sponsored by Merck Sharp & Dohme.

Completed
Registry status
Phase 3
Development phase
466
Enrollment target

NCT00625612: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.

NCT00625612 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 466 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00625612, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.

COMPLETED
Registry status
Phase 3
Development phase
466 participants
Enrollment target

Study Summary

The purpose of this trial is to evaluate the safety and effectiveness of one dose strength of Denufosol compared to placebo in patients with CF and a predicted FEV1 of greater than or equal to 75% but less than or equal to 110% predicted.

Interventions

  • DRUG Placebo
  • DRUG Denufosol Tetrasodium (INS37217) Inhalation Solution

Trial Details

FieldValue
Enrollment Target 466 participants
Start Date 2008-02
Est. Completion 2010-10
Phase Phase 3
Merck Sharp & Dohme

558 total trials

What the finished NCT00625612 record still lists

NCT00625612 is an interventional study that assigns participants to a tested intervention. The registered 466 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 (40% lower).

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

NCT00625612 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00625612 about?

NCT00625612 is a clinical study titled "Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease". The purpose of this trial is to evaluate the safety and effectiveness of one dose strength of Denufosol compared to placebo in patients with CF and a predicted FEV1 of greater than or equal to 75% but less than or equal to 110% predicted.

What is the current status of trial NCT00625612?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 466 participants. The study started on 2008-02. Estimated completion is 2010-10.

What interventions are being tested in trial NCT00625612?

The interventions under investigation include: Placebo (DRUG), Denufosol Tetrasodium (INS37217) Inhalation Solution (DRUG).

Who is sponsoring clinical trial NCT00625612?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00625612's enrollment target sits among peer trials

466 816th of 2000 higher than 1,182 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 NCT00625612, the US trial registry maintained by the National Library of Medicine. NCT00625612 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.