|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00645268 |
Purpose
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 double-blind sildenafil versus placebo for 4 weeks (Phase I) followed by an as-needed, flexible-dose, open-label treatment phase with sildenafil for 12 weeks (Phase II). To assess safety and tolerability of this dosing regimen and to investigate its effects on endothelial function and subject's responses to the Self-Esteem And Relationship (SEAR) questionnaire.
| Condition | Intervention | Phase |
|---|---|---|
|
Erectile Dysfunction Diabetes Mellitus, Type 2 |
Drug: sildenafil Drug: placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multicenter, Double-Blind Study to Evaluate the Effect of Pretreatment With a Daily Dose of Viagra® (Sildenafil Citrate) on the PRN Efficacy of Viagra in Men With Erectile Dysfunction and Type 2 Diabetes |
| Estimated Enrollment: | 300 |
| Study Start Date: | December 2002 |
| Study Completion Date: | January 2004 |
| Arms | Assigned Interventions |
|---|---|
| Arm 1: Active Comparator |
Drug: sildenafil
In the double-blind phase, patients received sildenafil 50 mg once daily during Week 1 (7 doses), followed by a daily dose of sildenafil 100 mg during the next 3 weeks.
|
| Arm 2: Placebo Comparator |
Drug: placebo
In the double-blind phase, patients received placebo once daily during Week 1 (7 doses), followed by a daily dose of placebo during the next 3 weeks.
|
| Open-Label Arm |
Drug: sildenafil
Eligible subjects then entered an open-label phase during which all subjects received sildenafil 50 mg as needed for sexual activity for the next 2 weeks, which could be titrated to either 25 mg or 100 mg based on the investigator's assessment of efficacy and tolerability, for 10 weeks (12 weeks total).
|
Eligibility| Ages Eligible for Study: | 35 Years to 70 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 Criteria:
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.
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Pfizer Investigational Site | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arizona | |
| Pfizer Investigational Site | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| Pfizer Investigational Site | |
| LaJolla, California, United States, 92037 | |
| Pfizer Investigational Site | |
| Beverly Hills, California, United States, 90212 | |
| Pfizer Investigational Site | |
| SAN DIEGO, California, United States, 92161 | |
| Pfizer Investigational Site | |
| Duarte, California, United States, 91010 | |
| Pfizer Investigational Site | |
| La Jolla, California, United States, 92093 | |
| Pfizer Investigational Site | |
| LOS ANGELES, California, United States, 90048 | |
| Pfizer Investigational Site | |
| LAGUNA WOODS, California, United States, 92653 | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| NORWALK, Connecticut, United States, 06850 | |
| Pfizer Investigational Site | |
| WATERBURY, Connecticut, United States, 06708 | |
| United States, Indiana | |
| Pfizer Investigational Site | |
| New Albany, Indiana, United States, 47150 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Overland Park, Kansas, United States, 66211 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Pfizer Investigational Site | |
| Baltimore, Maryland, United States, 21224 | |
| Pfizer Investigational Site | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Minnesota | |
| Pfizer Investigational Site | |
| MINNEAPOLIS, Minnesota, United States, 55416 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| ST. LOUIS, Missouri, United States, 63104 | |
| Pfizer Investigational Site | |
| Richmond Heights, Missouri, United States, 63117 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Buffalo, New York, United States, 14209 | |
| United States, Oregon | |
| Pfizer Investigational Site | |
| Portland, Oregon, United States, 97201 | |
| Pfizer Investigational Site | |
| MEDFORD, Oregon, United States, 97504 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| SAN ANTONIO, Texas, United States, 78217 | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78229-3894 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| TACOMA, Washington, United States, 98023 | |
| Pfizer Investigational Site | |
| Tacoma, Washington, United States, 98405 | |
| Pfizer Investigational Site | |
| KIRKLAND, Washington, United States, 98034 | |
| Pfizer Investigational Site | |
| Kirkland, Washington, United States, 98034 | |
| Canada | |
| Pfizer Investigational Site | |
| CALGARY, Canada, T2N2T9 | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A1481146 |
| Study First Received: | March 20, 2008 |
| Last Updated: | March 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00645268 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Sexual Dysfunctions, Psychological Vasodilator Agents Metabolic Diseases Molecular Mechanisms of Pharmacological Action Diabetes Mellitus Endocrine System Diseases Enzyme Inhibitors Sildenafil Cardiovascular Agents Genital Diseases, Male |
Sexual and Gender Disorders Pharmacologic Actions Phosphodiesterase Inhibitors Sexual Dysfunction, Physiological Mental Disorders Therapeutic Uses Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Erectile Dysfunction |
