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

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NCT00853112

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Study Location
Pulmonary Associates, PA
Phoenix, Arizona, 85006, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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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 < 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
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

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary Study will assess PF-00489791 efficacy and safety in Pulmonary Arterial Hypertension (PAH)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypertension, Pulmonary
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 20, 2017)		48
Original Estimated Enrollment  ICMJE
 (submitted: February 27, 2009)		72
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Germany,   India,   Russian Federation,   Spain,   Sweden,   Switzerland,   United States
Removed Location Countries Belgium
 
Administrative Information
NCT Number  ICMJE NCT00853112
Other Study ID Numbers  ICMJE A7331009
2008-003572-21 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP