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 - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00814736

Purpose

To investigate the safety and overall tolerability of co-administration two PDE5 inhibitors UK369,003 and sildenafil

Condition	Intervention	Phase
Prostatic Hyperplasia Urinary Bladder, Overactive Erectile Dysfunction	Drug: UK369,003 Drug: sildenafil Drug: sildenafil matching placebo	Phase I

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Sildenafil citrate Sildenafil

U.S. FDA Resources

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.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Safety and toleration assessed by non-leading questioning, incidence of adverse events and laboratory testing. [ Time Frame: hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of postural hypotension. [ Time Frame: hours ] [ Designated as safety issue: No ]
Standing and supine pulse rate (PR) at each postdose time. [ Time Frame: hours ] [ Designated as safety issue: No ]
Standing systolic and diastolic blood pressure (BP) and supine systolic and diastolic BP at each postdose time. [ Time Frame: hours ] [ Designated as safety issue: No ]

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
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	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

Eligibility

Ages Eligible for Study:	40 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814736

Locations

Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 15, 2009