NCT00457457

Study the Effects of Different Doses of UK-369,003 in Men With Lower Urinary Tract Symptoms.

A Multi-center, Randomized, Parallel Group, Double-blind, Placebo Controlled Proof of Concept and Dose Ranging Study With an Active Control to Assess the Efficacy and Safety/Tolerability of UK-369,003 Immediate Release (IR) and Modified Release (MR) in the Treatment of Men With Lower Urinary Tract Symptoms (LUTS) With and Without Erectile Dysfunction (ED)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 609 (actual)
• Sponsor: Pfizer · Industry
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a 12 week study in which different doses and formulations of UK-369,003 will be administered to patients with a diagnosis of enlarged prostate. Patients will complete a series of questionnaires before, during and after treatment to assess if UK-369,003 has improved their urinary symptoms and erectile function . There will be several blood samples taken during the study to asses the level of drug in the blood and correlate it with the responses to the questionnaires.

Conditions

• Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Tamsulosin	Tamsulosin hydrochloride capsules, 0.4 mg. Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate
DRUG	UK-369,003	UK 369,003 is a highly selective and potent inhibitor of PDE5. It has increased selectivity for PDE5 over PDE6 (\>80 fold) compared to sildenafil (\~10 fold). Two recently completed trials have shown efficacy for UK-369,003 in treating subjects with ED

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2007-04-06
• Last updated: 2018-12-19

Locations

46 sites across 15 countries: Australia, Belgium, Canada, Chile, Colombia, Denmark, Finland, Greece, Italy, Latvia, Lithuania, Poland, Slovakia, Spain, United Kingdom