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NCT00359801 · ClinicalTrials.gov registry record · Phase 4
Exubera Large Simple Trial To Evaluate Long-Term Pulmonary And Cardiovascular Safety
A Phase 4 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,976
- Enrollment target
NCT00359801: Completed Phase 4 study, sponsored by Pfizer.
NCT00359801 is a Phase 4 study that has completed, run by Pfizer. The registered enrollment target is 1,976 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (281% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00359801, a Phase 4 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,976 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the long-term pulmonary and cardiovascular safety of Exubera in routine clinical practice.
Primary Outcome
Persistent decline in FEV1 exceeding 20% from baseline: observed decline in FEV1 exceeding 20% from baseline, 3 months after a confirmed decline (2 consecutive declines within 1 month) in FEV1 exceeding 20% from baseline. Second pulmonary function test (PFT) that confirmed decline was to occur within 14-42 days of the decline. Persistence: PFT that established persistence was to occur within 60-120 days of the confirming (2nd) decline. Index Visit: date subject had final Scheduled spirometry; wa
Interventions
- DRUG Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,976 participants |
| Start Date | 2006-07 |
| Est. Completion | 2009-04 |
| Phase | Phase 4 |
What the finished NCT00359801 record still lists
NCT00359801 is an interventional study that assigns participants to a tested intervention. Its 1,976 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (281% higher).
The record links to 0 conditions, and to 1 intervention - of which Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care is the first listed.
NCT00359801 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00359801 about?
NCT00359801 is a clinical study titled "Exubera Large Simple Trial To Evaluate Long-Term Pulmonary And Cardiovascular Safety". The purpose of this study is to evaluate the long-term pulmonary and cardiovascular safety of Exubera in routine clinical practice.
What is the current status of trial NCT00359801?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,976 participants. The study started on 2006-07. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00359801?
The interventions under investigation include: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care (DRUG).
Who is sponsoring clinical trial NCT00359801?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00359801's enrollment target sits among peer trials
1,976 43rd of 2000 higher than 1,958 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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