Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor
NCT01150903
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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
- 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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor | |||
| Official Title | Prevalence and Incidence of Underlying Disease Diagnosed in Men With Erectile Dysfunction When Prescribed a PDE5i for the First Time | |||
| Brief 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? | |||
| Detailed Description | Not Provided | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case Control Time Perspective: Cross-Sectional | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Patients with a PDE5 inhibitor prescription and within the age-match control. | |||
| Condition |
| |||
| Intervention | Other: no intervention
non-interventional study | |||
| Study Groups/Cohorts |
| |||
| 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 Status | Completed | |||
| Actual Enrollment | 98832 | |||
| Original Estimated Enrollment | 50000 | |||
| Actual Study Completion Date | August 2010 | |||
| Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT01150903 | |||
| Other Study ID Numbers | A1481287 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | April 2012 | |||