Status:
COMPLETED
A Randomized, Double-Blinded, Placebo-Controlled, Two-Way Crossover Study to Investigate the Safety and Toleration of Single Dose Sildenafil in Subjects Receiving Chronic UK-369,0031
Lead Sponsor:
Pfizer
Conditions:
Prostatic Hyperplasia
Urinary Bladder, Overactive
Eligibility:
MALE
40-55 years
Phase:
PHASE1
Brief Summary
To investigate the safety and overall tolerability of co-administration two PDE5 inhibitors UK369,003 and sildenafil
Eligibility Criteria
Inclusion
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- Healthy male subjects between the ages of 40 and 55 years, inclusive
- Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs).
Exclusion
- Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Loss of vision in one eye due to non-arteritic ischemic optic neuropathy (NAION) regardless of whether or not this event was temporally associated with the use of a PDE5 inhibitor.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00814736
Start Date
August 1 2008
End Date
September 1 2008
Last Update
December 25 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
Singapore, Singapore, 188770