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NCT00425243 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Zolpidem-MR Administered Over a Long Term Period as Needed for Insomnia (ZOLONG)
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,025
- Enrollment target
NCT00425243: Completed Phase 3 study, sponsored by Sanofi.
NCT00425243 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 1,025 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00425243, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,025 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the hypnotic efficacy of zolpidem-MR 12.5 mg in comparison with placebo, when administered over a long-term period, on an "as needed" basis, in patients with chronic primary insomnia. Secondary objectives of the study are to evaluate the drug taking behavior over a long-term period and the clinical safety and tolerability of zolpidem-MR 12.5 mg in comparison to placebo administered over a long-term period, on an as needed basis.
Interventions
- DRUG zolpidem-MR (SL800750)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,025 participants |
| Start Date | 2004-08 |
| Est. Completion | 2006-01 |
| Phase | Phase 3 |
What the finished NCT00425243 record still lists
NCT00425243 is an interventional study that assigns participants to a tested intervention. Its 1,025 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 1 intervention - of which zolpidem-MR (SL800750) is the first listed.
NCT00425243 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00425243 about?
NCT00425243 is a clinical study titled "Efficacy and Safety of Zolpidem-MR Administered Over a Long Term Period as Needed for Insomnia (ZOLONG)". The primary objective of the study is to evaluate the hypnotic efficacy of zolpidem-MR 12.5 mg in comparison with placebo, when administered over a long-term period, on an "as needed" basis, in patients with chronic primary insomnia. Secondary objectives of the study are to evaluate the drug taking...
What is the current status of trial NCT00425243?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,025 participants. The study started on 2004-08. Estimated completion is 2006-01.
What interventions are being tested in trial NCT00425243?
The interventions under investigation include: zolpidem-MR (SL800750) (DRUG).
Who is sponsoring clinical trial NCT00425243?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00425243's enrollment target sits among peer trials
1,025 288th of 2000 higher than 1,713 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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