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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00814736 |
To investigate the safety and overall tolerability of co-administration two PDE5 inhibitors UK369,003 and sildenafil
Condition | Intervention | Phase |
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Prostatic Hyperplasia Urinary Bladder, Overactive Erectile Dysfunction |
Drug: UK369,003 Drug: sildenafil Drug: sildenafil matching placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety Study |
Official Title: | 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-369,003. |
Enrollment: | 22 |
Study Start Date: | August 2008 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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UK369,003 + Placebo or sildenafil: Experimental
All subjects will receive 17 days daily dosing of UK-369,003 100 mg MR Subjects will receive single oral doses of the following interactant treatments in a randomized order On Day 14, a single dose of sildenafil-matching placebo or 100 mg sildenafil and on Day 17 a single dose of 100 mg sildenafil or a sildenafil matching placebo
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Drug: UK369,003
oral tablet, once a day
Drug: sildenafil
single oral dose on day 14 or day 17
Drug: sildenafil matching placebo
single oral dose on day 14 or day 17
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Ages Eligible for Study: | 40 Years to 55 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A3711051 |
Study First Received: | November 3, 2008 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00814736 |
Health Authority: | Singapore: Domain Specific Review Boards |
Sexual Dysfunctions, Psychological Urinary Bladder, Overactive Cystocele Prostatic Diseases Urinary Bladder Diseases Sildenafil Genital Diseases, Male |
Signs and Symptoms Hyperplasia Sexual Dysfunction, Physiological Prostatic Hyperplasia Urologic Diseases Mental Disorders Erectile Dysfunction |
Urological Manifestations Vasodilator Agents Phosphodiesterase Inhibitors Pathologic Processes Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Enzyme Inhibitors Cardiovascular Agents Sexual and Gender Disorders Pharmacologic Actions |