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

NCT00457457

Last updated date
Study Location
Pfizer Investigational Site
Herston, Queensland, , Australia
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostatic Hyperplasia
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Urinary tract infection


2. Primary neurological conditions affecting bladder function

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study the Effects of Different Doses of UK-369,003 in Men With Lower Urinary Tract Symptoms.
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Prostatic Hyperplasia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 2, 2008)
609
Original Enrollment  ICMJE
 (submitted: April 5, 2007)
414
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Chile,   Colombia,   Denmark,   Finland,   Greece,   Italy,   Latvia,   Lithuania,   Poland,   Slovakia,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00457457
Other Study ID Numbers  ICMJE A3711044
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2018

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