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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00457457
First received: April 5, 2007
Last updated: October 27, 2010
Last verified: October 2010

April 5, 2007
October 27, 2010
May 2007
April 2008   (final data collection date for primary outcome measure)
Change in international prostate symptom score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change in international prostate symptom score
Complete list of historical versions of study NCT00457457 on ClinicalTrials.gov Archive Site
  • Erectile Function (EF) domain of International Index of Erectile [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Function (IIEF) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Qmax [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Quality of Erection questionnaire (QEQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Population pharmacokinetics [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Erectile Function (EF) domain of International Index of Erectile Function (IIEF) Qmax Quality of Erection questionnaire (QEQ) Population pharmacokinetics
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
609
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
Male
40 Years and older
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
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2010

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