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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

NCT ID: NCT00814736

Last Updated: 2008-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-09-30

Brief Summary

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

Detailed Description

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Conditions

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Prostatic Hyperplasia Urinary Bladder, Overactive Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

UK369,003

Intervention Type DRUG

oral tablet, once a day

sildenafil

Intervention Type DRUG

single oral dose on day 14 or day 17

sildenafil matching placebo

Intervention Type DRUG

single oral dose on day 14 or day 17

Interventions

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UK369,003

oral tablet, once a day

Intervention Type DRUG

sildenafil

single oral dose on day 14 or day 17

Intervention Type DRUG

sildenafil matching placebo

single oral dose on day 14 or day 17

Intervention Type DRUG

Other Intervention Names

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viagra

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Singapore, , Singapore

Site Status

Countries

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Singapore

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3711051&StudyName=A%20randomized%2C%20double-blinded%2C%20placebo-controlled%2C%20two-way%20crossover%20study%20to%20investigate%20the%20safety%20and%20toleration%20of%20single%20dose%20Silden

To obtain contact information for a study center near you, click here.

Other Identifiers

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A3711051

Identifier Type: -

Identifier Source: org_study_id