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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00853112
• Date of registration: 27/02/2009
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: 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
• Scientific 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 Arterial Hypertension
• Date of first enrolment: April 2009
• Target sample size: 48
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00853112
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Belgium, Canada, Germany, India, Russian Federation, Spain, Sweden, Switzerland, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension, Pulmonary

Intervention(s)

Drug: sildenafil

Drug: PF-00489791

Drug: placebo

Primary Outcome(s)

Mean Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) Over 4 Hours Post Dose [Time Frame: Baseline, up to 4 hours post-dose on Day 1]

Secondary Outcome(s)

Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose [Time Frame: Baseline, 1, 2, 3, 4 hours post-dose on Day 1]

Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose [Time Frame: Baseline, 1, 2, 3, 4 hours post-dose on Day 1]

Mean Change From Baseline in Systemic Vascular Resistance Index (SVRI) Over 4 Hours Post Dose [Time Frame: Baseline, up to 4 hours post-dose on Day 1]

Number of Participants With Clinically Significant Laboratory Values [Time Frame: Baseline up-to follow up (Day 3 to 5)]

Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) at Hour 1, 2, 3 and 4 Post Dose [Time Frame: Baseline, 1, 2, 3, 4 hours post-dose on Day 1]

Change From Baseline in Mean Partial Pressure of Oxygen (PaO2) and Carbon Dioxide (PaCO2) at Hour 1 and 4 Post Dose [Time Frame: Baseline; 1, 4 hours post-dose on Day 1]

Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) and Systemic Vascular Resistance (SVR) at Hour 1, 2, 3 and 4 Post Dose [Time Frame: Baseline, 1, 2, 3, 4 hours post-dose on Day 1]

Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Values [Time Frame: Baseline up-to follow up (Day 3 to 5)]

Change From Baseline in Systemic Vascular Resistance Index (SVRI) at Hour 1, 2, 3 and 4 Post Dose [Time Frame: Baseline, 1, 2, 3, 4 hours post-dose on Day 1]

Change From Baseline in Cardiac Index (CI) at Hour 1, 2, 3 and 4 Post Dose [Time Frame: Baseline, 1, 2, 3, 4 hours post-dose on Day 1]

Greatest Reduction From Baseline in Pulmonary Vascular Resistance Index (PVRI) and Systemic Vascular Resistance Index (SVRI) Over 4 Hours Post Dose [Time Frame: Baseline, up to 4 hours post-dose on Day 1]

Plasma Concentration of PF-00489791 and Sildenafil [Time Frame: 1, 2, 3, 4, 5, 6, 8 hours post-dose on Day 1, follow up (Day 3 to 5)]

Mean Change From Baseline in Heart Rate (HR) at Hour 1, 2, 3 and 4 Post Dose [Time Frame: Baseline, 1, 2, 3, 4 hours post-dose on Day 1]

Secondary ID(s)

A7331009

2008-003572-21

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/10/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00853112