Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial Hypertension

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NCT00159887

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233, United States
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Contact
1-800-718-1021
[email protected]
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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]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary 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 with PAH who had completed the 12 week pivotal study

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


- Any other patients with PAH that had not been included into the pivotal study

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Pfizer Clinical Trials Contact Center

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial Hypertension
Official Title  ICMJE A Multi-Centre, Multinational, Long-Term Extension Study, to Assess the Safety and Toleration of Subject Optimised Treatment Regimens of Oral Sildenafil Citrate for Pulmonary Arterial Hypertension in Subjects Who Have Completed Study A1481140.
Brief Summary Open label extension study to the pivotal efficacy study to assess the safety of sildenafil citrate in patients with pulmonary arterial hypertension
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Hypertension
Intervention  ICMJE Drug: Sildenafil citrate
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2011)		260
Original Enrollment  ICMJE
 (submitted: September 11, 2005)		278
Actual Study Completion Date  ICMJE February 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with PAH who had completed the 12 week pivotal study

Exclusion Criteria:

  • Any other patients with PAH that had not been included into the pivotal study
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   Czechia,   Denmark,   France,   Germany,   Hong Kong,   Hungary,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   Poland,   Singapore,   South Africa,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00159887
Other Study ID Numbers  ICMJE A1481142
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP