You are here

Our science / Clinical Trials / Find a Trial / NCT01365585

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

Back to Search Print Save as PDF Bookmark Trial

NCT01365585

Last updated on November 8, 2019
Back to Search Print Save as PDF Bookmark Trial

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Advanced Search

Based on your search, you may also be interested in

Pulmonary Arterial Hypertension
Effects of Oral Sildenafil on Mortality in Adults With PAH
NCT02060487
All Genders
18+
Years
Multiple Sites
Pulmonary Arterial Hypertension
Revavtio Special Investigation for Long-term Use in Pediatric Patients
NCT03364244
All Genders
0+
Years
Tokyo,
Descriptive Information
Brief TitleEvaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ?20mg TID For The Treatment Of Pulmonary Arterial Hypertension
Official TitleEvaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ?20mg TID For The Treatment Of Pulmonary Arterial Hypertension
Brief SummaryThe 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 DescriptionThe 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 TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPatients at least 18 years of age diagnosed with pulmonary arterial hypertension (PAH; per Dana Point classification) and treated with sildenafil citrate for their PAH
ConditionPulmonary Arterial Hypertension
InterventionDrug: sildenafil citrate
Sildenafil citrate, 20mg oral tablets, taken at least three times daily
Study Groups/CohortsSildenafil ?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 StatusCompleted
Actual Enrollment
 (submitted: January 8, 2013)		227
Original Estimated Enrollment
 (submitted: June 1, 2011)		400
Actual Study Completion DateOctober 2011
Actual Primary Completion DateOctober 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
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesGermany,   Ireland
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01365585
Other Study ID NumbersA1481297
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now