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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00814736
Recruitment Status : Completed
First Posted : December 25, 2008
Last Update Posted : December 25, 2008
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Brief Summary:
To investigate the safety and overall tolerability of co-administration two PDE5 inhibitors UK369,003 and sildenafil

Condition or disease Intervention/treatment Phase
Prostatic Hyperplasia Urinary Bladder, Overactive Erectile Dysfunction Drug: UK369,003 Drug: sildenafil Drug: sildenafil matching placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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.
Study Start Date : August 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

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Arm Intervention/treatment
Experimental: UK369,003 + Placebo or sildenafil
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
Drug: UK369,003
oral tablet, once a day

Drug: sildenafil
single oral dose on day 14 or day 17
Other Name: viagra

Drug: sildenafil matching placebo
single oral dose on day 14 or day 17

Primary Outcome Measures :
  1. Safety and toleration assessed by non-leading questioning, incidence of adverse events and laboratory testing. [ Time Frame: hours ]

Secondary Outcome Measures :
  1. Incidence of postural hypotension. [ Time Frame: hours ]
  2. Standing and supine pulse rate (PR) at each postdose time. [ Time Frame: hours ]
  3. Standing systolic and diastolic blood pressure (BP) and supine systolic and diastolic BP at each postdose time. [ Time Frame: hours ]

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Ages Eligible for Study:   40 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 Criteria:

  • 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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00814736

Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00814736     History of Changes
Other Study ID Numbers: A3711051
First Posted: December 25, 2008    Key Record Dates
Last Update Posted: December 25, 2008
Last Verified: December 2008

Additional relevant MeSH terms:
Erectile Dysfunction
Prostatic Hyperplasia
Urinary Bladder, Overactive
Pathologic Processes
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Prostatic Diseases
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents