Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ≥20mg TID For The Treatment Of Pulmonary Arterial Hypertension

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NCT01365585

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Study Location
Medizinische Hochschule Hannover
Hannover, , 30625, Germany
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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.
Pulmonary Arterial Hypertension
Sex
Females and Males
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

- 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

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


- 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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Advanced Information
Descriptive Information
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
 (submitted: January 8, 2013)		227
Original Estimated Enrollment
 (submitted: June 1, 2011)		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:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study:All
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 ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2021