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NCT00379756 · ClinicalTrials.gov registry record · Phase 4
A Study Evaluating Vardenafil Compared to Placebo in Subjects With Erectile Dysfunction (ED) and Dyslipidemia
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 395
- Enrollment target
NCT00379756 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 395 participants.
The verdict
NCT00379756, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 395 participants
- Enrollment target
Study Summary
This is a study consisting of four periods (screening, run-in, treatment, follow-up). A four-week treatment-free, run-in period where the subject will make at least four attempts at intercourse on four separate days with at least 50% of the attempts must be unsuccessful. During run-in the subjects will be using a stopwatch to measure the time from erection perceived hard enough for penetration until withdrawal from the partner's vagina. Next there are 12 weeks of treatment with either placebo or LEVITRA. Each subject will be required to visit the clinic on 5 occasions over a period of 4 months.
Interventions
- DRUG placebo
- DRUG LEVITRA (vardenafil)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 395 participants |
| Start Date | 2006-05-22 |
| Est. Completion | 2007-05-17 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00379756
The ClinicalTrials.gov registry entry for NCT00379756 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 395 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00379756 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00379756 about?
NCT00379756 is a clinical study titled "A Study Evaluating Vardenafil Compared to Placebo in Subjects With Erectile Dysfunction (ED) and Dyslipidemia". This is a study consisting of four periods (screening, run-in, treatment, follow-up). A four-week treatment-free, run-in period where the subject will make at least four attempts at intercourse on four separate days with at least 50% of the attempts must be unsuccessful. During run-in the subjects w...
What is the current status of trial NCT00379756?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 395 participants. The study started on 2006-05-22. Estimated completion is 2007-05-17.
What interventions are being tested in trial NCT00379756?
The interventions under investigation include: placebo (DRUG), LEVITRA (vardenafil) (DRUG).
Who is sponsoring clinical trial NCT00379756?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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