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Urodynamic Effects of UK-369,003 in Men With Lower Urinary Tract Symptoms

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NCT00408954

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Brno, , 612 00 Czech Republic
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Contact
1-800-718-1021
[email protected]
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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

- 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 15 ml/sec with a voided volume of ≥150 ml

- Urodynamically defined bladder outlet obstruction

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

- prostate cancer

- Post-void residual urine volume >200 ml

- Documented UTI

- History of relevant urological surgery

NCT00408954
Pfizer
Completed
Urodynamic Effects of UK-369,003 in Men With Lower Urinary Tract Symptoms

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Urodynamic Effects of UK-369,003 in Men With Lower Urinary Tract Symptoms
A Multi Center Randomized Cross Over Double Blind Third Party Open Placebo Controlled Pilot Study to Assess the Urodynamic Effects of Modified Release UK-369,003 in Men With Lower Urinary Tract Symptoms.
This is a pilot study to generate hypotheses about the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Prostatic Hyperplasia
  • Drug: UK-369,003
    100 mg MR tablet once daily for 2 weeks
  • Drug: UK-369,003
    UK-369,003-100 mg MR formulation for 2 weeks
  • Placebo Comparator: Placebo
    Intervention: Drug: UK-369,003
  • Active Comparator: UK-369,003
    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
27
June 2008
June 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 15 ml/sec with a voided volume of ?150 ml
  • Urodynamically defined bladder outlet obstruction

Exclusion Criteria:

  • prostate cancer
  • Post-void residual urine volume >200 ml
  • Documented UTI
  • History of relevant urological surgery
Sexes Eligible for Study: Male
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Netherlands,   Slovakia
 
 
NCT00408954
A3711045
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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