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
Tracking Information| Start Date ICMJE | March 2009 |
|---|
| Estimated Primary Completion Date | May 2010 (final data collection date for primary outcome measure) |
|---|
Current Primary Outcome Measures ICMJE
(submitted: February 27, 2009) | Mean change from baseline in PVRI [ Time Frame: Day 1, 4 hours post dose ] [ Designated as safety issue: No ] |
|---|
| Original Primary Outcome Measures ICMJE | Same as current |
|---|
| Change History | Complete list of historical versions of study NCT00853112 on ClinicalTrials.gov Archive Site |
|---|
Current Secondary Outcome Measures ICMJE
(submitted: December 8, 2009) | - Hourly changes from baseline in cardiac index, mean PAP and other hemodynamic parameters [ Time Frame: Day 1, up to 4 hours post dose ] [ Designated as safety issue: No ]
- Changes from baseline in PaO2 and PaCO2 [ Time Frame: Day 1, up to 4 hours post dose ] [ Designated as safety issue: Yes ]
- Plasma concentrations of PF-00489791 and sildenafil [ Time Frame: up to Day 3 - 5 ] [ Designated as safety issue: No ]
- Safety and tolerability of PF-00489791 after a single dose administration as assessed by incidence of treatment-emergent adverse events, changes from baseline in clinical laboratory tests, and ECG [ Time Frame: up to Day 3 - 5 ] [ Designated as safety issue: Yes ]
- Greatest reduction and hourly changes from baseline in PVRI [ Time Frame: Day 1, up to 4 hours post dose ] [ Designated as safety issue: No ]
- Mean change, greatest reduction and hourly changes from baseline in SVRI [ Time Frame: Day 1, up to 4 hours post dose ] [ Designated as safety issue: No ]
- Safety and tolerability of PF-00489791 after a single dose administration as assessed by incidence of treatment-emergent adverse events [ Time Frame: up to Day 10 - 14 ] [ Designated as safety issue: Yes ]
|
|---|
Original Secondary Outcome Measures ICMJE
(submitted: February 27, 2009) | - Hourly changes from baseline in cardiac index, mean PAP and other hemodynamic parameters [ Time Frame: Day 1, up to 4 hours post dose ] [ Designated as safety issue: No ]
- Changes from baseline in PaO2 and PaCO2 [ Time Frame: Day 1, up to 4 hours post dose ] [ Designated as safety issue: Yes ]
- Plasma concentrations of PF-00489791 and sildenafil [ Time Frame: up to Day 4 ] [ Designated as safety issue: No ]
- Safety and tolerability of PF-00489791 after a single dose administration as assessed by incidence of treatment-emergent adverse events, changes from baseline in clinical laboratory tests, and ECG [ Time Frame: up to Day 4 ] [ Designated as safety issue: Yes ]
- Greatest reduction and hourly changes from baseline in PVRI [ Time Frame: Day 1, up to 4 hours post dose ] [ Designated as safety issue: No ]
- Mean change, greatest reduction and hourly changes from baseline in SVRI [ Time Frame: Day 1, up to 4 hours post dose ] [ Designated as safety issue: No ]
- Safety and tolerability of PF-00489791 after a single dose administration as assessed by incidence of treatment-emergent adverse events [ Time Frame: up to Day 10 - 14 ] [ Designated as safety issue: Yes ]
|
|---|
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 Hypertension |
|---|
| Brief Summary | Study will assess PF-00489791 efficacy and safety in Pulmonary Arterial Hypertension (PAH) |
|---|
| Detailed Description | |
|---|
| Study Phase | Phase II |
|---|
| Study Type ICMJE | Interventional |
|---|
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
|---|
| 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 / Comparison Groups | - PF-00489791 1 mg: Experimental
Intervention: Drug: PF-00489791 - PF-00489791 2 mg: Experimental
Intervention: Drug: PF-00489791 - PF-00489791 4 mg: Experimental
Intervention: Drug: PF-00489791 - PF-00489791 10 mg: Experimental
Intervention: Drug: PF-00489791 - PF-00489791 20 mg: Experimental
Intervention: Drug: PF-00489791 - Placebo: Placebo Comparator
Intervention: Drug: placebo - Sildenafil: Active Comparator
Observational comparator arm Intervention: Drug: sildenafil
|
|---|
Recruitment Information| Estimated Enrollment ICMJE | 72 |
|---|
| Estimated Completion Date | May 2010 |
|---|
| Estimated Primary Completion Date | May 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
|
|---|
| Gender | Both |
|---|
| Ages | 18 Years and older |
|---|
| Accepts Healthy Volunteers | No |
|---|
| Contacts ICMJE | | Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | | |
|
|---|
| Location Countries ICMJE | United States, Belgium, Canada, Germany, India, Russian Federation, Spain, Sweden, Switzerland |
|---|
Administrative Information| NCT ID ICMJE | NCT00853112 |
|---|
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
|---|
| Study ID Numbers ICMJE | A7331009 |
|---|
| Study Sponsor ICMJE | Pfizer |
|---|
| Collaborators ICMJE | |
|---|
| Investigators ICMJE | | Study Director: | Pfizer CT.gov Call Center | Pfizer | |
|
|---|
| Information Provided By | Pfizer |
|---|
|
