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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00457457
Recruitment Status : Completed
First Posted : April 6, 2007
Last Update Posted : November 1, 2010
Information provided by:

April 5, 2007
April 6, 2007
November 1, 2010
May 2007
April 2008   (Final data collection date for primary outcome measure)
Change in international prostate symptom score [ Time Frame: 12 weeks ]
Change in international prostate symptom score
Complete list of historical versions of study NCT00457457 on Archive Site
  • Erectile Function (EF) domain of International Index of Erectile [ Time Frame: 12 weeks ]
  • Function (IIEF) [ Time Frame: 12 weeks ]
  • Qmax [ Time Frame: 12 weeks ]
  • Quality of Erection questionnaire (QEQ) [ Time Frame: 12 weeks ]
  • Population pharmacokinetics [ Time Frame: 12 weeks ]
Erectile Function (EF) domain of International Index of Erectile Function (IIEF) Qmax Quality of Erection questionnaire (QEQ) Population pharmacokinetics
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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.
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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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2008
April 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
40 Years and older   (Adult, Older Adult)
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
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Director, Clinical Trial Disclosure Group, Pfizer Inc
Not Provided
Study Director: Pfizer Call Center Pfizer
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP