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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01150903
Other study ID # A1481287
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2010
Est. completion date August 2010

Study information

Verified date July 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Erectile 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?


Recruitment information / eligibility

Status Completed
Enrollment 98832
Est. completion date August 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Other:
no intervention
non-interventional study
no intervention
non-interventional study

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Underlying Condition Until Day -1 of the Index PDE5i Prescription Underlying conditions were defined as any diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders. Day -92 up to Day -1 of index prescription
Primary Cumulative Percentage of Participants With New Diagnosis of Underlying Condition Between Index PDE5i Prescription (Day 0) and Day 91 New diagnosis of underlying condition at prescription was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders. Day 0 to Day 91 post index prescription
Primary Percentage of Participants With New Diagnosis of Underlying Condition Between Day -92 and Day -1 Prior to the Index PDE5i Prescription New diagnosis of underlying condition was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders. Day -92 up to Day -1 of index prescription
Primary Percentage of Participants With New Diagnosis of Underlying Condition Between Day 366 and Day 457 Post the Index PDE5i Prescription New diagnosis of underlying condition was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders. Day 366 up to Day 457 post index prescription
Primary Percentage of Participants With Underlying Condition at PDE5i Market Introduction During the Early Study Period Underlying condition at PDE5i market introduction was defined as any diagnosis of interest until day -1 in participants who received the index prescription between January 1, 1999 and December 31, 2001 for the three years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders. Up to 3 years (Early study period - January 1999 to December 2001)
Secondary Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Market Introduction During the Early Study Period New diagnosis of underlying condition at PDE5i market introduction was defined as any new diagnosis of interest until day -1 in participants who received the index prescription between January 1, 1999 and December 31, 2001 for the three years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders. Up to 3 years (Early study period - January 1999 to December 2001)
Secondary Percentage of Participants With Underlying Condition at PDE5i Establishment During the End of Study Period Underlying condition at PDE5i market introduction was defined as any diagnosis of interest until day -1 in participants who received the index prescription between July 1, 2006 and June 30, 2008 for the two years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders. Up to 2 years (End of study period - July 2006 to June 2008)
Secondary Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Establishment During the End of Study Period New diagnosis of underlying condition at PDE5i establishment was defined as any new diagnosis of interest between day 0 (index prescription) and day 91 in participants who received the index prescription between July 1, 2006 and June 30, 2008 for the two-years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders. Up to 2 years (End of study period - July 2006 to June 2008)
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