Benign Prostatic Hyperplasia Clinical Trial
Official title:
A Multi-Center, Open-Label Evaluation of the Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia
A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.
This will be a multi-center, open-label 40 week investigation in up to 1,200 men with signs
and symptoms of benign prostatic hyperplasia. The following procedures are utilized:
physical exams, electrocardiograms, clinical laboratory tests, vital signs, the
International Prostate Symptom Score, maximum urine flow rate, adverse events, concomitant
medications, and compliance.
All subjects had previously participated in a 12-week double-blind placebo controlled trial
(NCT000224107 or NCT000224120)
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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|---|---|---|---|
| Recruiting |
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||
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Phase 3 | |
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Α Prospective Observational Study for the Evaluation of Disease Control and Quality of Life in Patients With Benign PROStatic hyPERplasia Under Fixed Dose combΙnaTion Treatment With Dutasteride and Tamsulosin . PROSPERITY Group of Studies (I&II)
|