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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Hypertension, Pulmonary

In brief

Study will assess PF-00489791 efficacy and safety in Pulmonary Arterial Hypertension (PAH)

Key facts

Study ID

NCT00853112

Run by

Pfizer

People needed

48

Starts

2009-04-01

Expected to finish

2010-07-01

Last updated by the study team

2017-10-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pulmonary Associates, PA — Phoenix, Arizona, United States
• John C. Lincoln Hospital, North Mountain — Phoenix, Arizona, United States
• Pulmonary Associates, PA — Phoenix, Arizona, United States
• Shands at University of Florida — Gainesville, Florida, United States
• Creighton University Medical Center — Omaha, Nebraska, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• UT Southwestern Medical Center - Department of Internal Medicine Pulmonary — Dallas, Texas, United States
• UT Southwestern St. Paul Hospital — Dallas, Texas, United States
• Lawson Health Research Institute — London, Ontario, Canada
• London Health Sciences Centre — London, Ontario, Canada
• Sir Mortimer B. Davis, Jewish General Hospital — Montreal, Quebec, Canada
• Thoraxklinik am Universitaetsklinikum — Heidelberg, Germany
• Department Of Cardiology, MediCiti Hospital, — Hyderabad, Andhra Pardesh, India
• Department Of Cardiology, Sri Venkateswara Institute Of Medical Sciences — Tirupati, Andhra Pardesh, India
• Bankers Heart Institute — Vadodara, Gujarat, India
• Omega Hospital — Mangalore, Karnataka, India
• Moscow Healthcare Institution "City Clinical Hospital No. 57" — Moscow, Russia
• Institute of Cardiosurgery n.a. V.I.Burakovsky — Moscow, Russia
• Hospital General Universitari Vall D´Hebron — Barcelona, Spain
• Hospital Clinic I Provincial — Barcelona, Spain
• Hospital Universitario 12 de Octubre — Madrid, Spain
• Universitetssjukhuset i Lund, Hjart- och Lungdivisionen — Lund, Sweden
• Norrlands Universitetssjukhus, Kliniskt Forsknings Centrum — Umeå, Sweden
• Akademiska Sjukhuset, Kardiologen 50F/Forskningsenheten — Uppsala, Sweden
• Universitaetsspittal Zuerich, Medizinische Klinik A — Zurich, Switzerland

Full record on ClinicalTrials.gov

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