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 - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00853112

Purpose

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

Condition	Intervention	Phase
Hypertension, Pulmonary	Drug: PF-00489791 Drug: placebo Drug: sildenafil	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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 Hypertension

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Sildenafil Sildenafil citrate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Mean change from baseline in PVRI [ Time Frame: Day 1, 4 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hourly changes from baseline in cardiac index, mean PAP and other hemodynamic parameters [ Time Frame: Day 1, up to 4 hours post dose ] [ Designated as safety issue: No ]
Changes from baseline in PaO2 and PaCO2 [ Time Frame: Day 1, up to 4 hours post dose ] [ Designated as safety issue: Yes ]
Plasma concentrations of PF-00489791 and sildenafil [ Time Frame: up to Day 3 - 5 ] [ Designated as safety issue: No ]
Safety and tolerability of PF-00489791 after a single dose administration as assessed by incidence of treatment-emergent adverse events, changes from baseline in clinical laboratory tests, and ECG [ Time Frame: up to Day 3 - 5 ] [ Designated as safety issue: Yes ]
Greatest reduction and hourly changes from baseline in PVRI [ Time Frame: Day 1, up to 4 hours post dose ] [ Designated as safety issue: No ]
Mean change, greatest reduction and hourly changes from baseline in SVRI [ Time Frame: Day 1, up to 4 hours post dose ] [ Designated as safety issue: No ]
Safety and tolerability of PF-00489791 after a single dose administration as assessed by incidence of treatment-emergent adverse events [ Time Frame: up to Day 10 - 14 ] [ Designated as safety issue: Yes ]

Enrollment:	44
Study Start Date:	April 2009
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PF-00489791 1 mg	Drug: PF-00489791 tablet form, 1 mg, single dose (Day 1)
Experimental: PF-00489791 2 mg	Drug: PF-00489791 tablet form, 2 mg, single dose (Day 1)
Experimental: PF-00489791 4 mg	Drug: PF-00489791 tablet form, 4 mg, single dose (Day 1)
Experimental: PF-00489791 10 mg	Drug: PF-00489791 tablet form, 10 mg, single dose (Day 1)
Experimental: PF-00489791 20 mg	Drug: PF-00489791 tablet form, 20 mg, single dose (Day 1)
Placebo Comparator: Placebo	Drug: placebo tablet form, single dose (Day 1)
Active Comparator: Sildenafil Observational comparator arm	Drug: sildenafil tablet form, 20 mg, single dose (Day 1) Other Name: Revatio

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00853112

Locations

United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85006
Pfizer Investigational Site
Phoenix, Arizona, United States, 85020
United States, Florida
Pfizer Investigational Site
Gainesville, Florida, United States, 32610
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68131
United States, Pennsylvania
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75390
Canada, Ontario
Pfizer Investigational Site
London, Ontario, Canada, N6A 4G5
Pfizer Investigational Site
London, Ontario, Canada, N6A 5A5
Pfizer Investigational Site
London, Ontario, Canada, N6A 5W9
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H3T 1E2
Germany
Pfizer Investigational Site
Heidelberg, Germany, 69126
India
Pfizer Investigational Site
Hyderabad, Andhra Pardesh, India, 500 063
Pfizer Investigational Site
Tirupati, Andhra Pardesh, India, 517 507
Pfizer Investigational Site
Vadodara, Gujarat, India, 390 015
Pfizer Investigational Site
Mangalore, Karnataka, India, 575 002
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 121552
Pfizer Investigational Site
Moscow, Russian Federation, 105077
Spain
Pfizer Investigational Site
Barcelona, Spain, 08035
Pfizer Investigational Site
Barcelona, Spain, 08036
Pfizer Investigational Site
Madrid, Spain, 28041
Sweden
Pfizer Investigational Site
Lund, Sweden, 221 85
Pfizer Investigational Site
Umea, Sweden, 901 85
Pfizer Investigational Site
Uppsala, Sweden, 751 85
Switzerland
Pfizer Investigational Site
Zuerich, Switzerland, CH-8091

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00853112 History of Changes
Other Study ID Numbers:	A7331009
Study First Received:	February 27, 2009
Last Updated:	August 20, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

PAH pulmonary hypertension pulmonary arterial hypertension

Additional relevant MeSH terms:

Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Sildenafil
Vasodilator Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012