Effects of Oral Sildenafil on Mortality in Adults With PAH
NCT02060487
ABOUT THIS STUDY
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Subjects ≥ 18 <75 years of Age with any of the following conditions:
- Idiopathic Primary Pulmonary Arterial Hypertension (IPAH)
- PAH secondary to connective tissue disease
- PAH with surgical repair (at least 5 years previously) of atrial septal defect (ASD),ventricular septal defect (VSD), patent ductus arteriosus (PDA) and aorto-pulmonary window
- PAH diagnosis confirmed by right heart catheterization performed within 12 months prior to randomization
- Functional Class II-IV; Baseline 6MWD ≥ 50 m.
- Significant (ie, >2+) valvular disease other than tricuspid regurgitation or pulmonary
regurgitation
- History of cardiac arrest, respiratory arrest, hemodynamic collapse, CPR, ventricular
tachycardia, ventricular fibrillation, or uncontrolled atrial fibrillation
- History of pulmonary embolism; History of chronic lung disease / restrictive lung
disease (eg, chronic obstructive pulmonary disease (COPD) or scleroderma) with
impairment of lung function
- No prior long term treatment with PDE-5 inhibitors
- Treatment with bosentan OR riociguat within 3 months of randomization
- Current treatment with nitrates or nitric oxide
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Descriptive Information | |||||||
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Brief Title ICMJE | Effects of Oral Sildenafil on Mortality in Adults With PAH | ||||||
Official Title ICMJE | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) | ||||||
Brief Summary | This is a blinded study in adult patients with PAH evaluating the relative effects of sildenafil on mortality when administered at the three doses (80 mg, 20 mg or 5 mg, all three times per day [TID]). In addition, the relative effects on clinical worsening and 6-minute walking distance (6MWD) will be assessed. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||
Condition ICMJE | Pulmonary Arterial Hypertension | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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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 | Active, not recruiting | ||||||
Actual Enrollment ICMJE | 385 | ||||||
Original Estimated Enrollment ICMJE | 429 | ||||||
Estimated Study Completion Date ICMJE | November 30, 2020 | ||||||
Estimated Primary Completion Date | November 30, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Subjects ? 18 <75 years of age with any of the following conditions:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 74 Years (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 | Australia, Belgium, Bosnia and Herzegovina, Croatia, Czechia, Germany, Greece, Hong Kong, Israel, Latvia, Malaysia, Mexico, Poland, Romania, Russian Federation, Serbia, Singapore, South Africa, Spain, Thailand, Turkey, Ukraine, United States | ||||||
Removed Location Countries | Austria, Czech Republic, Netherlands, Portugal | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02060487 | ||||||
Other Study ID Numbers ICMJE | A1481324 2013-004362-34 ( EudraCT Number ) AFFILIATE ( Other Identifier: Alias Study Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | November 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |