Back to resultsAssessment Of Duration Of Action, Safety & Toleration Of UK369,003 and Cialis In Patients With Erectile Dysfunction
Primary Purpose
Impotence
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
UK0369,003
Cialis (Tadalafil)
Sponsored by
About this trial
This is an interventional treatment trial for Impotence
Eligibility Criteria
Inclusion Criteria: Erectile Dysfunction Exclusion Criteria: Alpha blockers and Nitrates of any preparation
Sites / Locations
Outcomes
Primary Outcome Measures
Assessment of duration of action, safety & toleration of the investigational drug and Cialis
Secondary Outcome Measures
Assess safety & toleration over 4 week treatment period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00174486
Brief Title
Assessment Of Duration Of Action, Safety & Toleration Of UK369,003 and Cialis In Patients With Erectile Dysfunction
Official Title
A Double Blind, Placebo Controlled, Parallel Group, Multicenter Study To Assess The Duration Of Action, Safety And Toleration Of Differing Doses and Combinations Of Immediate and Modified Release Formulations Of UK-369,003 and Cialis Compared To Placebo In Adult Male Subjects With Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
Assessment of duration of action, safety & toleration of different formulations and doses of UK-369,003 and Cialis in patients with male erectile dysfunction. Patients should have previously been on PDE5 inhibitors and have been respondents to the drug. Duration of treatment is 4 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impotence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
UK0369,003
Intervention Type
Drug
Intervention Name(s)
Cialis (Tadalafil)
Primary Outcome Measure Information:
Title
Assessment of duration of action, safety & toleration of the investigational drug and Cialis
Secondary Outcome Measure Information:
Title
Assess safety & toleration over 4 week treatment period
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Erectile Dysfunction
Exclusion Criteria:
Alpha blockers and Nitrates of any preparation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Assessment Of Duration Of Action, Safety & Toleration Of UK369,003 and Cialis In Patients With Erectile Dysfunction
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