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NCT00701779 · ClinicalTrials.gov registry record · Phase 4
Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia
A Phase 4 study, sponsored by Siami, Paul F., M.D..
- Completed
- Registry status
- Phase 4
- Development phase
- 63
- Enrollment target
NCT00701779: Completed Phase 4 study, sponsored by Siami, Paul F., M.D..
NCT00701779 is a Phase 4 study that has completed, run by Siami, Paul F., M.D.. The registered enrollment target is 63 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00701779, a Phase 4 study, has completed, sponsored by Siami, Paul F., M.D..
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 63 participants
- Enrollment target
Study Summary
This study will investigate the efficacy and safety of treatment with Dutasteride (0.5mg), administered once daily for one year in combination with Tamsulosin (0.4mg), administered once daily for 3 months, followed by counseling on flexible dosing of Tamsulosin on an as needed basis, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia (BPH). At each scheduled visit (3, 6, and 9 months), the subject will be counseled on withdrawal of Tamsulosin. After randomization, study visits are every 13 weeks for up to 52 Weeks. (Including Screening, (up to 7 clinic visits)
Primary Outcome
Reported mean total IPSS values from end of study (12 month visit) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients. Questionnaire consisting of seven symptom scores: incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Symptoms are scored on a 5 point scale with 0 representing absenc
Interventions
- DRUG Tamsulosin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2005-09 |
| Est. Completion | 2009-07 |
| Phase | Phase 4 |
What the finished NCT00701779 record still lists
NCT00701779 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Tamsulosin is the first listed.
NCT00701779 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00701779 about?
NCT00701779 is a clinical study titled "Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia". This study will investigate the efficacy and safety of treatment with Dutasteride (0.5mg), administered once daily for one year in combination with Tamsulosin (0.4mg), administered once daily for 3 months, followed by counseling on flexible dosing of Tamsulosin on an as needed basis, on the improvem...
What is the current status of trial NCT00701779?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 63 participants. The study started on 2005-09. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00701779?
The interventions under investigation include: Tamsulosin (DRUG).
Who is sponsoring clinical trial NCT00701779?
This trial is sponsored by Siami, Paul F., M.D., which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00701779's enrollment target sits among peer trials
63 1106th of 2000 higher than 891 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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