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NCT00655629 · ClinicalTrials.gov registry record · Phase 3
Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older.
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 339
- Enrollment target
NCT00655629 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 339 participants.
The verdict
NCT00655629, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 339 participants
- Enrollment target
Study Summary
This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.
Interventions
- DRUG Placebo
- DRUG Vardenafil ODT (STAXYN, BAY38-9456)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 339 participants |
| Start Date | 2008-04 |
| Est. Completion | 2009-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00655629
The ClinicalTrials.gov registry entry for NCT00655629 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 339 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00655629 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00655629 about?
NCT00655629 is a clinical study titled "Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older.". This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil O...
What is the current status of trial NCT00655629?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 339 participants. The study started on 2008-04. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00655629?
The interventions under investigation include: Placebo (DRUG), Vardenafil ODT (STAXYN, BAY38-9456) (DRUG).
Who is sponsoring clinical trial NCT00655629?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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