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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Hypertension, Pulmonary

Treatments: Drug: PF-00489791; Drug: placebo; Drug: sildenafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00853112

2008-003572-21 (EudraCT Number)

A7331009

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 7 patient groups, including a placebo group

PF-00489791 1 mg

Experimental group

Treatment:

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

PF-00489791 2 mg

Experimental group

Treatment:

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

PF-00489791 4 mg

Experimental group

Treatment:

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

PF-00489791 10 mg

Experimental group

Treatment:

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

PF-00489791 20 mg

Experimental group

Treatment:

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Placebo

Placebo Comparator group

Treatment:

Drug: placebo

Sildenafil

Active Comparator group

Description:

Observational comparator arm

Treatment:

Drug: sildenafil