A Multi-center, Randomized, Parallel Group, Double-blind, Placebo ControlledEstimation Study to Assess the Efficacy and Safety of Modified Release UK-369,003 inthe Treatment of Men with Storage Lower Urinary Tract Symptoms (LUTS) With andWithout Erectile Dysfunction (ED) - not applicable

Phase 1

• Conditions: Storage male lower urinary tract symptoms (LUTS) with and without erectile dysfunction (ED).; MedDRA version: 9.1Level: LLTClassification code 10046566Term: Urinary tract disorder

• Registration Number: EUCTR2006-006656-35-SK
• Lead Sponsor: Pfizer Ltd, Ramsgate Road, Sandwich, Kent. UK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-18
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 350

Inclusion Criteria

1. Male subjects aged 18 years and above, with documented clinical diagnosis of OAB as verified by the screening LUTS diary defined by:
• Mean urinary frequency =8 times /24 hours.
• Mean number of urgency episodes, with or without urgency incontinence =1 episode /24 hours.
2. Mean voided volume <300 ml as verified by the bladder diary completed prior to
randomization.
3. Qmax >5 ml/sec with a voided volume >150 ml.
4. Stable sexual partner for the duration of the trial.
5. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
6. Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests and other trial procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History, evidence or suspicion of prostate cancer (includes total Prostate Specific Antigen (PSA) value > 10 ng/ml unless prostate cancer previously excluded by biopsy) at screening visit or during the course of the trial.
2. Post-void residual urine volume >200 ml based on bladder ultrasound at screening visit.
3. Documented urinary tract infection (UTI) at screening visit; subjects with a positive (1+ or greater) leukocyte or nitrite result in urine dipstick test will be excluded unless UTI can be ruled out via urine culture.
4. Greater than 1+ of hematuria on dipstick test at screening visit, unless fully investigated prior to randomization (baseline visit) to rule out significant urological disease.
5. History of relevant urological surgery or procedures that may contribute to LUTS (e.g. prostatectomy, bladder neck surgery, minimally invasive procedures of the prostate, prostatic stent insertion, pelvic irradiation, cystoscopy < 30 days prior to randomization at baseline visit).
6. Chronic persistent local lower urinary tract pathology (e.g. bladder neck contracture, prostatitis, bladder stone, cystitis, urethral stricture, carcinoma, large bladder diverticulum, recurrent gross hematuria).
7. Known primary neurological conditions such as multiple sclerosis, Parkinson’s disease, or other neurological diseases known to affect bladder function.
8. History of catheterization for outflow obstruction in the previous 12 months prior to screening visit (includes intermittent self-catheterization).
9. Use of any electrostimulation or bladder training in the past 30 days or who are expected to start such treatment during the study.
10. Subjects with a total volume voided of > 3000 ml on average per 24 hours, as confirmed by the LUTS diary completed prior to randomization.
11. Subjects receiving or who are likely to receive any of the following medications or
treatments during the trial period:
• a-blockers, muscarinic receptor antagonists, PDE5 inhibitors, and agents known to
affect vesico-urethral function or erectile function (including vacuum devices). Such
treatments must be terminated at least four weeks prior to randomization at baseline visit and must not be taken at any time during the trial.
• 5-a-RIs (unless at stable dose for six months prior to randomization at baseline visit, and stable dose maintained through duration of the trial).
• Diuretics, beta-blockers or other anti-hypertensive agents (unless stable for four
weeks prior to visit 3 (baseline) and stable dose maintained throughout the duration of the trial).
• Nitrates or nitric oxide donors in any form on either regular or intermittent basis (oral, sublingual, buccal, transdermal, inhalation or aerosols).
• Potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, miconazole,
clotrimazole, nefazadone, clarithromycin, troleandomycin, ritonavir and saquinavir).
Topical agents are permitted.
• Warfarin.
12. Significant allergy to or known hypersensitivity or intolerance to PDE5 inhibitors or any of the excipients in the formulation.
13. Increased susceptibility to vasodilators including those subjects with left ventricular outflow obstruction (e.g., hypertrophic obstructive cardiomyopathy).
14. Poorly controlled type I or type II diabetes mellitus as defined by HbA1C >7% at
screening visit.
15. Loss of vision in one eye due to non-arteritic ischemic optic neuropathy (NAION)
regardless of whether or not this event was temporally associated with the use of a PDE5 inhibit

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified