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NCT00369343 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women
A Phase 3 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 381
- Enrollment target
NCT00369343: Completed Phase 3 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
NCT00369343 is a Phase 3 study that has completed, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 381 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00369343, a Phase 3 study, has completed, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 381 participants
- Enrollment target
Study Summary
Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). The sustained-release (SR) formulation, DVS SR, is being studied in the development program for the treatment of major depressive disorder (MDD), for vasomotor symptoms (VMS) associated with menopause, and for pain associated with peripheral diabetic neuropathy, as well as for the treatment of fibromyalgia syndrome. This study will investigate the safety, efficacy, and tolerability of DVS SR in women with MDD who are peri- and postmenopausal.
Primary Outcome
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17
Interventions
- DRUG Placebo
- DRUG Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 381 participants |
| Start Date | 2006-09 |
| Est. Completion | 2008-07 |
| Phase | Phase 3 |
What the finished NCT00369343 record still lists
NCT00369343 is an interventional study that assigns participants to a tested intervention. The registered 381 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 (51% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00369343 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00369343 about?
NCT00369343 is a clinical study titled "Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women". Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). The sustained-release (SR) formulation, DVS SR, is being studied in the development program for the treatment of major depressive disorder (MDD), for vasomotor symptoms (VMS) associated w...
What is the current status of trial NCT00369343?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 381 participants. The study started on 2006-09. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00369343?
The interventions under investigation include: Placebo (DRUG), Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR) (DRUG).
Who is sponsoring clinical trial NCT00369343?
This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00369343's enrollment target sits among peer trials
381 982nd of 2000 higher than 1,018 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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