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Completed

NCT Number: NCT00814736

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

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

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Key information

Conditions

Prostatic Hyperplasia Erectile Dysfunction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Mental Disorders Pathological Conditions, Signs and Symptoms Prostatic Diseases Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

40 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

UK369,003

Drug

oral tablet, once a day

Sildenafil

Drug

single oral dose on day 14 or day 17

Other names: viagra

sildenafil matching placebo

Drug

single oral dose on day 14 or day 17

Primary outcomes

  1. Safety and toleration assessed by non-leading questioning, incidence of adverse events and laboratory testing.

    Time frame: hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Dec 25, 2008
Registry last updated
Dec 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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