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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

Last updated on April 11, 2018
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FOR MORE INFORMATION
Study Location
Medizinische Hochschule Hannover
Hannover, , 30625 Germany
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NCT01365585
Pfizer
Completed
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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Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ?20mg TID For The Treatment Of Pulmonary Arterial Hypertension
Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ?20mg TID For The Treatment Of Pulmonary Arterial Hypertension
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
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
Pulmonary Arterial Hypertension
Drug: sildenafil citrate
Sildenafil citrate, 20mg oral tablets, taken at least three times daily
Sildenafil ?20mg three times daily
Subjects receiving sildenafil ?20mg three times daily for the treatment of PAH
Intervention: Drug: sildenafil citrate
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
227
October 2011
October 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Ireland
 
 
NCT01365585
A1481297
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

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