A Research Study To Assess The Effectiveness And Safety Of Different Doses Of Oral PF-00489791 In The Treatment Of Adult Patients With Pulmonary Arterial Hypertension
NCT00853112
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Idiopathic or familial pulmonary arterial hypertension (PAH)
- Mean PAP at least 25 mm Hg, PCWP < 15 mm Hg at rest
- For females of child-bearing potential negative pregnancy test at screening and use of contraception during the study and 4 weeks after its completion
- Signed and dated informed consent
- Willingness to comply with the study plan and procedures
- pulmonary arterial hypertension (PAH)other than idiopathic or familial
- For females, pregnancy or lactation
- Use of specific PAH treatments, potent CYP3A4 inhibitors, protease inhibitors, alpha
blockers or arginine 30 days prior tio randomization and during the study
- Change of dose or class of standard background PAH therapy, i.e. oxygen, calcium
channel blockers, digoxin, diuretics 30 days prior tio randomization and during the
study
- Large shift in altitude (defined as >5000 feet or 1524 meters) during 90 days prior to
baseline visit and/or during the study visit
- Subjects with intracardiac shunts and/or serious heart, lung or other health
conditions
- HIV positive subjects
- Subjects participating in another clinical trial with an investigational drug or
device
- Subjects with degenerative retinal disorders, history of non-arteritic anterior
ischemic optic neuropathy or untreated proliferative diabetic retinopathy
- Allergies and previous intolerance of PDE5 inhibitors
- Alcohol or drug abuse
- Blood donation during the study, or 1 month before or after the study
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Descriptive Information | ||||
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Brief Title ICMJE | A Research Study To Assess The Effectiveness And Safety Of Different Doses Of Oral PF-00489791 In The Treatment Of Adult Patients With Pulmonary Arterial Hypertension | |||
Official Title ICMJE | A Phase 2a, Randomized, Double Blind, Placebo-controlled, Parallel Group Study Investigating The Dose-response Of Pf-00489791 On Acute Hemodynamics In Subjects With Idiopathic And Familial Pulmonary Arterial Hypertension | |||
Brief Summary | Study will assess PF-00489791 efficacy and safety in Pulmonary Arterial Hypertension (PAH) | |||
Detailed Description | Pfizer decided to stop this trial early upon Stage 1 completion due to change in PF-00489791 development and not as a result of safety concerns for PF-00489791. Date of termination (LSLV) occurred on July 28, 2010. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Hypertension, Pulmonary | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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 ICMJE | Terminated | |||
Actual Enrollment ICMJE | 48 | |||
Original Estimated Enrollment ICMJE | 72 | |||
Actual Study Completion Date ICMJE | July 2010 | |||
Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
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 | Canada, Germany, India, Russian Federation, Spain, Sweden, Switzerland, United States | |||
Removed Location Countries | Belgium | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00853112 | |||
Other Study ID Numbers ICMJE | A7331009 2008-003572-21 ( EudraCT Number ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | September 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |