Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ≥20mg TID For The Treatment Of Pulmonary Arterial Hypertension
NCT01365585
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- Patients must be at least 18 years of age at study index;
- Patients must have a diagnosis of PAH. PAH is conventionally defined as a mean pulmonary arterial pressure (PAP) of > 25 mmHg and a pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg and a pulmonary vascular resistance (PVR) ≥ 240 dynes/s/cm-5 at right heart catheterization;
- Patients must have initiated sildenafil for the treatment of their PAH; at dose ≥ 20 mg tid within 5 years prior to study initiation
- Patient has known contraindications to sildenafil at study index;
- Patient participated in an investigational study of sildenafil treatment for PAH
during the period beginning 6 months prior to study index
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Descriptive Information | ||||
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Brief Title | Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ?20mg TID For The Treatment Of Pulmonary Arterial Hypertension | |||
Official Title | Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ?20mg TID For The Treatment Of Pulmonary Arterial Hypertension | |||
Brief Summary | The objective of this observational study is to gain clinical insight on the actual use of sildenafil citrate (Revatio?) for the treatment of pulmonary arterial hypertension (PAH). The primary objective is to assess effectiveness and safety of sildenafil at doses ?20mg three times daily for the treatment of PAH. | |||
Detailed Description | The study design proposed is a retrospective chart review going back five years (01 April 2006 estimate) from the time of study initiation (31 March 2011 estimate). Within this five-year period, study index will occur the first time an adult patient begins sildenafil for the treatment of PAH for a period of at least three months. The patient has to be taking sildenafil at doses ? 20mg tid for the treatment of PAH. | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Retrospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Patients at least 18 years of age diagnosed with pulmonary arterial hypertension (PAH; per Dana Point classification) and treated with sildenafil citrate for their PAH | |||
Condition | Pulmonary Arterial Hypertension | |||
Intervention | Drug: sildenafil citrate
Sildenafil citrate, 20mg oral tablets, taken at least three times daily | |||
Study Groups/Cohorts | Sildenafil ?20mg three times daily
Subjects receiving sildenafil ?20mg three times daily for the treatment of PAH Intervention: Drug: sildenafil citrate | |||
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 | Completed | |||
Actual Enrollment | 227 | |||
Original Estimated Enrollment | 400 | |||
Actual Study Completion Date | October 2011 | |||
Actual Primary Completion Date | October 2011 (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 | Germany, Ireland | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01365585 | |||
Other Study ID Numbers | A1481297 | |||
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 | March 2017 |