Status:
COMPLETED
A Multicenter, Double-blind Study to Evaluate the Effect of Pretreatment With a Daily Dose of Sildenafil on the As-Needed Efficacy of Viagra in Men With Erectile Dysfunction and Type 2 Diabetes
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Erectile Dysfunction
Diabetes Mellitus, Type 2
Eligibility:
MALE
35-70 years
Phase:
PHASE4
Brief Summary
To determine the effect on erectile function in a population of type 2 diabetic men with erectile dysfunction who have undergone the following treatment regimen: pre-treatment with a daily dose of dou...
Eligibility Criteria
Inclusion
- Patients had a documented clinical diagnosis of erectile dysfunction, a sexual partner for the duration of the study, and have a HbAlc of less than or equal to 10 at screening. Type 2 diabetic patients currently on insulin or on combination therapy with an oral hypoglycemic agent were not excluded.
Exclusion
- Excluded were subjects who had taken more than 6 doses of any PDE5 inhibitor and/or had taken their last dose less than 4 weeks prior to the screening visit; subjects with resting sitting and/or standing hypotension (BP \< 90/50mmHg) or hypertension (BP \> 170/110mmHg); and subjects with significant cardiovascular disease, including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation in the last 3 months.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2004
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00645268
Start Date
December 1 2002
End Date
January 1 2004
Last Update
February 1 2021
Active Locations (29)
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1
Pfizer Investigational Site
Huntsville, Alabama, United States, 35801
2
Pfizer Investigational Site
Phoenix, Arizona, United States, 85006
3
Pfizer Investigational Site
Beverly Hills, California, United States, 90212
4
Pfizer Investigational Site
Duarte, California, United States, 91010