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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00814736
First received: November 3, 2008
Last updated: December 22, 2008
Last verified: December 2008
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00814736     History of Changes
Other Study ID Numbers: A3711051
Study First Received: November 3, 2008
Last Updated: December 22, 2008
Health Authority: Singapore: Domain Specific Review Boards

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

ClinicalTrials.gov processed this record on September 16, 2014