Assessment of Onset, Safety & Toleration of UK-369,003 in Male Erectile Dysfunction

NCT00141349

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35205, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Impotence
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Erectile dysfunction as defined by DSM-IV. Patients should have been PDE5 inhibitor respondents

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


- Alpha blockers and Nitrates of any preparation

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ImpotenceAssessment of Onset, Safety & Toleration of UK-369,003 in Male Erectile Dysfunction NCT00141349
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Birmingham, Alabama
  4. Mesa, Arizona
  5. Mesa, Arizona
  6. Mesa, Arizona
  7. Tempe, Arizona
  8. Beverly Hills, California
  9. San Bernardino, California
  10. Torrance, California
  11. Waterbury, Connecticut
  12. Aventura, Florida
  13. Pembroke Pines, Florida
  14. St. Petersburg, Florida
  15. West Palm Beach, Florida
  16. Evansville, Indiana
  17. Fort Wayne, Indiana
  18. Jeffersonville, Indiana
  19. Metairie, Louisiana
  20. Metairie, Louisiana
  21. Milford, Massachusetts
  22. Kansas City, Missouri
  23. New Brunswick, New Jersey
  24. Albany, New York
  25. Endwell, New York
  26. New York, New York
  27. Raleigh, North Carolina
  28. Raleigh, North Carolina
  29. Winston-Salem, North Carolina
  30. Beachwood, Ohio
  31. Cincinnati, Ohio
  32. Cleveland, Ohio
  33. Bryan, Texas
  34. Sugar Land, Texas
  35. Salt Lake City, Utah
  36. West Jordan, Utah
  37. Norfolk, Virginia
  38. Richmond, Virginia
  39. Milwaukee, Wisconsin
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Assessment of Onset, Safety & Toleration of UK-369,003 in Male Erectile Dysfunction
Official Title  ICMJE A Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Assess the Time to Onset, Safety, and Toleration of Differing Doses and Combinations of Immediate Release and Modified Release Formulations of UK369,003 in Adult Male Subject With Erectile Dysfunction
Brief Summary To determine the onset of action, safety and toleration of different formulations and doses of UK-369,003 in patients with erectile dysfunction. Patients should have been previously treated with PDE5 inhibitors and have been responders to the drugs. Duration of treatment is 4 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Impotence
Intervention  ICMJE Drug: UK-369,003
Study Arms  ICMJE Not Provided
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
Enrollment  ICMJE
 (submitted: August 30, 2005)
300
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Erectile dysfunction as defined by DSM-IV. Patients should have been PDE5 inhibitor respondents

Exclusion Criteria:

  • Alpha blockers and Nitrates of any preparation
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years to 65 Years   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00141349
Other Study ID Numbers  ICMJE A3711029
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2006

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