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 | Terminated Phase 2 Results DMC

• 2 other identifiers: A73310092008-003572-21
• Study Type: interventional
• Target: 48
• Locations: 8 countries
• Sites: 25

Brief Summary

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

Conditions

Hypertension, Pulmonary

Keywords

PAH pulmonary hypertension pulmonary arterial hypertension

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) Over 4 Hours Post Dose

  PVRI was calculated as: PVRI (in Wood units\*meter\^2 \[m\^2\]) = pulmonary vascular resistance (PVR) multiplied by body surface area (BSA). PVR (in Wood units) = (mean pulmonary artery pressure \[mean PAP\] minus pulmonary capillary wedge pressure \[PCWP\]) divided by cardiac output (CO, taken as the average of the triplicate measurements). BSA (m\^2) = (0.007184) multiplied by (height in centimeters \[cm\])\^0.725 multiplied by (weight in kilograms \[kg\])\^0.425. PVRI values were converted to dyne\*second (s)\*m\^2/centimeter (cm)\^5 from Woods units by multiplying by a factor of 79.9. The change from baseline in PVRI over 4-hour interval was calculated as the average of the change from baseline values at 1, 2, 3, and 4 hours post dose on Day 1.

  Baseline, up to 4 hours post-dose on Day 1

Secondary Outcomes (13)

• Greatest Reduction From Baseline in Pulmonary Vascular Resistance Index (PVRI) and Systemic Vascular Resistance Index (SVRI) Over 4 Hours Post Dose

  Baseline, up to 4 hours post-dose on Day 1

• Mean Change From Baseline in Systemic Vascular Resistance Index (SVRI) Over 4 Hours Post Dose

  Baseline, up to 4 hours post-dose on Day 1

• Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) at Hour 1, 2, 3 and 4 Post Dose

  Baseline, 1, 2, 3, 4 hours post-dose on Day 1

• Change From Baseline in Systemic Vascular Resistance Index (SVRI) at Hour 1, 2, 3 and 4 Post Dose

  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

  Baseline, 1, 2, 3, 4 hours post-dose on Day 1

Study Arms (7)

PF-00489791 1 mg

EXPERIMENTAL

Drug: PF-00489791

PF-00489791 2 mg

EXPERIMENTAL

Drug: PF-00489791

PF-00489791 4 mg

EXPERIMENTAL

Drug: PF-00489791

PF-00489791 10 mg

EXPERIMENTAL

Drug: PF-00489791

PF-00489791 20 mg

EXPERIMENTAL

Drug: PF-00489791

Placebo

PLACEBO COMPARATOR

Drug: placebo

Sildenafil

ACTIVE COMPARATOR

Observational comparator arm

Drug: sildenafil

Interventions

PF-00489791 DRUG

tablet form, 1 mg, single dose (Day 1)

PF-00489791 1 mg

placebo DRUG

tablet form, single dose (Day 1)

Placebo

sildenafil DRUG

tablet form, 20 mg, single dose (Day 1)

Also known as: Revatio

Sildenafil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (25)

Pulmonary Associates, PA

Phoenix, Arizona, 85006, United States

Location

John C. Lincoln Hospital, North Mountain

Phoenix, Arizona, 85020, United States

Location

Pulmonary Associates, PA

Phoenix, Arizona, 85020, United States

Location

Shands at University of Florida

Gainesville, Florida, 32610, United States

Location

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

UT Southwestern Medical Center - Department of Internal Medicine Pulmonary

Dallas, Texas, 75390, United States

Location

UT Southwestern St. Paul Hospital

Dallas, Texas, 75390, United States

Location

Lawson Health Research Institute

London, Ontario, N6A 4G5, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Sir Mortimer B. Davis, Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Thoraxklinik am Universitaetsklinikum

Heidelberg, 69126, Germany

Location

Department Of Cardiology, MediCiti Hospital,

Hyderabad, Andhra Pardesh, 500 063, India

Location

Department Of Cardiology, Sri Venkateswara Institute Of Medical Sciences

Tirupati, Andhra Pardesh, 517 507, India

Location

Bankers Heart Institute

Vadodara, Gujarat, 390 015, India

Location

Omega Hospital

Mangalore, Karnataka, 575 002, India

Location

Moscow Healthcare Institution "City Clinical Hospital No. 57"

Moscow, 105077, Russia

Location

Institute of Cardiosurgery n.a. V.I.Burakovsky

Moscow, 121552, Russia

Location

Hospital General Universitari Vall D´Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic I Provincial

Barcelona, 08036, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Universitetssjukhuset i Lund, Hjart- och Lungdivisionen

Lund, 221 85, Sweden

Location

Norrlands Universitetssjukhus, Kliniskt Forsknings Centrum

Umeå, 901 85, Sweden

Location

Akademiska Sjukhuset, Kardiologen 50F/Forskningsenheten

Uppsala, 751 85, Sweden

Location

Universitaetsspittal Zuerich, Medizinische Klinik A

Zurich, CH-8091, Switzerland

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

PF-00489791; Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Study was terminated prematurely as further continuation would not have meaningfully contributed to the next phase of development.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2009
• First Posted: March 2, 2009
• Study Start: April 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 24, 2017
• Results First Posted: October 24, 2017

Record last verified: 2017-09

Locations

RU (2); DE (1); CH (1); CA (3); US (8); IN (4); ES (3); SE (3)