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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

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ClinicalTrials.gov Identifier: NCT00814736
Recruitment Status : Completed
First Posted : December 25, 2008
Last Update Posted : December 25, 2008
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE November 3, 2008
First Posted Date  ICMJE December 25, 2008
Last Update Posted Date December 25, 2008
Study Start Date  ICMJE August 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2008)
Safety and toleration assessed by non-leading questioning, incidence of adverse events and laboratory testing. [ Time Frame: hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2008)
  • Incidence of postural hypotension. [ Time Frame: hours ]
  • Standing and supine pulse rate (PR) at each postdose time. [ Time Frame: hours ]
  • Standing systolic and diastolic blood pressure (BP) and supine systolic and diastolic BP at each postdose time. [ Time Frame: hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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.
Brief Summary To investigate the safety and overall tolerability of co-administration two PDE5 inhibitors UK369,003 and sildenafil
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Prostatic Hyperplasia
  • Urinary Bladder, Overactive
  • Erectile Dysfunction
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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
Interventions:
  • Drug: UK369,003
  • Drug: sildenafil
  • Drug: sildenafil matching placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 22, 2008)
22
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00814736
Other Study ID Numbers  ICMJE A3711051
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP