You are here

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

Last updated on March 22, 2018

FOR MORE INFORMATION
Study Location
Pulmonary Associates, PA
Phoenix, Arizona, 85006 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Idiopathic or familial pulmonary arterial hypertension (PAH)

- Mean PAP at least 25 mm Hg, PCWP

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00853112
Pfizer
Terminated
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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Familial Persistent Pulmonary Hypertension
NCT01720524
All Genders
0+
Years
Multiple Sites
Pulmonary Hypertension
NCT00946114
All Genders
18+
Years
Multiple Sites
Venous Thrombosis, Pulmonary Embolism, Intracranial Sinus Thrombosis
NCT01297348
Females
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
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
Study will assess PF-00489791 efficacy and safety in Pulmonary Arterial Hypertension (PAH)
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypertension, Pulmonary
  • Drug: PF-00489791
    tablet form, 1 mg, single dose (Day 1)
  • Drug: PF-00489791
    tablet form, 2 mg, single dose (Day 1)
  • Drug: PF-00489791
    tablet form, 4 mg, single dose (Day 1)
  • Drug: PF-00489791
    tablet form, 10 mg, single dose (Day 1)
  • Drug: PF-00489791
    tablet form, 20 mg, single dose (Day 1)
  • Drug: placebo
    tablet form, single dose (Day 1)
  • Drug: sildenafil
    tablet form, 20 mg, single dose (Day 1)
    Other Name: Revatio
  • Experimental: PF-00489791 1 mg
    Intervention: Drug: PF-00489791
  • Experimental: PF-00489791 2 mg
    Intervention: Drug: PF-00489791
  • Experimental: PF-00489791 4 mg
    Intervention: Drug: PF-00489791
  • Experimental: PF-00489791 10 mg
    Intervention: Drug: PF-00489791
  • Experimental: PF-00489791 20 mg
    Intervention: Drug: PF-00489791
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
  • Active Comparator: Sildenafil
    Observational comparator arm
    Intervention: Drug: sildenafil
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
48
July 2010
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Germany,   India,   Russian Federation,   Spain,   Sweden,   Switzerland,   United States
Belgium
 
NCT00853112
A7331009
2008-003572-21 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now