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Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor

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NCT01150903

Last updated on October 11, 2019
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Erectile Dysfunction, Cardiovascular Diseases, Male Urogenital Diseases
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Records of men aged >18 years with an index PDE5 inhibitor (sildenafil, tadalafil or
vardenafil) prescription between January 1st, 1999, and June 30th, 2008

- no prior PDE5 inhibitor prescription before the index prescription

- continuous enrolment with medical history for ≥60 months prior to the index
prescription date

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Records of female subjects and any male subjects not meeting the inclusion criteria
will be excluded

- A subject can only be selected once independent of the assignment to the target or the
control populations.

NCT01150903
Pfizer
Completed
Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor

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Descriptive Information
Brief TitleIdentification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor
Official TitlePrevalence and Incidence of Underlying Disease Diagnosed in Men With Erectile Dysfunction When Prescribed a PDE5i for the First Time
Brief SummaryErectile dysfunction (ED) has been identified as an independent risk factor for existing cardiovascular disease, preceding a major cardiovascular event by an average of about 5 years. Are men prescribed a PDE5 inhibitor for ED more likely to have a new diagnosis of underlying medical conditions compared to men of a similar age not receiving PDE5 inhibitor treatment?
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPatients with a PDE5 inhibitor prescription and within the age-match control.
Condition
  • Erectile Dysfunction
  • Cardiovascular Diseases
  • Male Urogenital Diseases
InterventionOther: no intervention
non-interventional study
Study Groups/Cohorts
  • PDE5 inhibitor prescription
    Intervention: Other: no intervention
  • Age-matched Control
    Intervention: Other: no intervention
Publications *Kirby MG, Schnetzler G, Zou KH, Symonds T. Prevalence and detection rate of underlying disease in men with erectile dysfunction receiving phosphodiesterase type 5 inhibitors in the United Kingdom: a retrospective database study. Int J Clin Pract. 2011 Jul;65(7):797-806. doi: 10.1111/j.1742-1241.2011.02693.x.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: January 11, 2011)		98832
Original Estimated Enrollment
 (submitted: June 24, 2010)		50000
Actual Study Completion DateAugust 2010
Actual Primary Completion DateJuly 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Records of men aged >18 years with an index PDE5 inhibitor (sildenafil, tadalafil or vardenafil) prescription between January 1st, 1999, and June 30th, 2008
  • no prior PDE5 inhibitor prescription before the index prescription
  • continuous enrolment with medical history for ?60 months prior to the index prescription date

Exclusion Criteria:

  • Records of female subjects and any male subjects not meeting the inclusion criteria will be excluded
  • A subject can only be selected once independent of the assignment to the target or the control populations.
Sex/Gender
Sexes Eligible for Study:Male
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01150903
Other Study ID NumbersA1481287
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2012

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

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