Official Title: “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)”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Comparator
  • Tamsulosin 0.4 mg prolonged release
• Experimental: Treatment Arm
  • There are 5 possible UK-369,003 arms as follows: UK-369,003 MR (10mg, 25mg, 50mg & 100mg), UK-369,003 IR (40mg),

Primary Measures

• Change in international prostate symptom score
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Erectile Function (EF) domain of International Index of Erectile
  • Time Frame: 12 weeks
    Safety Issue?: No
• Function (IIEF)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Qmax
  • Time Frame: 12 weeks
    Safety Issue?: No
• Quality of Erection questionnaire (QEQ)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Population pharmacokinetics
  • Time Frame: 12 weeks
    Safety Issue?: No

Inclusion Criteria:

• 1. Male subjects aged 40 years and above, with documented LUTS with an International
• Prostate Symptom Score (IPSS) ≥13
• 2. Clinical diagnosis of BPH.
• 3. Qmax 5 to 15ml/sec with a voided volume of ≥150ml at visit 1 (screening).

Exclusion Criteria:

• 1. Urinary tract infection
• 2. Primary neurological conditions affecting bladder function

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00457457

Study ID Number: A3711044

ClinicalTrials.gov Identifier: NCT00457457

Health Authority: Slovakia: State Institute for Drug Control

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