| 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) |
| 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. |
| Not Provided |
| Interventional |
| Phase 2 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment |
| Prostatic Hyperplasia |
- 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
|
- Active Comparator: Comparator
Tamsulosin 0.4 mg prolonged release
Intervention: Drug: Tamsulosin
- 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),
Intervention: Drug: UK-369,003
|
| Not Provided |
| |
| Completed |
| 609 |
| April 2008 |
| April 2008 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Male subjects aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ?13
- Clinical diagnosis of BPH.
- Qmax 5 to 15ml/sec with a voided volume of ?150ml at visit 1 (screening).
Exclusion Criteria:
- Urinary tract infection
- Primary neurological conditions affecting bladder function
|
| Sexes Eligible for Study: |
Male |
|
| 40 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Australia, Belgium, Canada, Chile, Colombia, Denmark, Finland, Greece, Italy, Latvia, Lithuania, Poland, Slovakia, Spain, United Kingdom |
| |
| |
| NCT00457457 |
| A3711044 |
| No |
| Not Provided |
| Not Provided |
| Director, Clinical Trial Disclosure Group, Pfizer Inc |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| October 2010 |
