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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 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 1,025 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00425243
The ClinicalTrials.gov registry entry for NCT00425243 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,025 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which zolpidem-MR (SL800750) is the first listed.
NCT00425243 reports 0 study locations.
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.
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