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NCT00630175 · ClinicalTrials.gov registry record · Phase 3
Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 113
- Enrollment target
NCT00630175: Completed Phase 3 study, sponsored by Sanofi.
NCT00630175 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 113 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00630175, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 113 participants
- Enrollment target
Study Summary
The primary objective is to evaluate the hypnotic efficacy of zolpidem-MR (modified release) 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo in patients with primary insomnia and sleep maintenance difficulties, using polysomnography (PSG) recordings and patient sleep questionnaires. The secondary objective is to evaluate the clinical safety and tolerability of zolpidem-MR 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo.
Interventions
- DRUG placebo
- DRUG zolpidem-MR (modified release)
- DRUG zolpidem (SL800750)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2003-09 |
| Est. Completion | 2004-02 |
| Phase | Phase 3 |
What the finished NCT00630175 record still lists
NCT00630175 is an interventional study that assigns participants to a tested intervention. The registered 113 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 (85% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00630175 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00630175 about?
NCT00630175 is a clinical study titled "Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia". The primary objective is to evaluate the hypnotic efficacy of zolpidem-MR (modified release) 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo in patients with primary insomnia and sleep maintenance difficulties, using polysomnography (PSG) recordings and patient sleep questionn...
What is the current status of trial NCT00630175?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 113 participants. The study started on 2003-09. Estimated completion is 2004-02.
What interventions are being tested in trial NCT00630175?
The interventions under investigation include: placebo (DRUG), zolpidem-MR (modified release) (DRUG), zolpidem (SL800750) (DRUG).
Who is sponsoring clinical trial NCT00630175?
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 NCT00630175's enrollment target sits among peer trials
113 1651st of 2000 higher than 349 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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