Effects of Oral Sildenafil on Mortality in Adults With PAH (AFFILIATE)
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ClinicalTrials.gov Identifier: NCT02060487 |
Recruitment Status :
Terminated
(Study was terminated by Sponsor at recommendation of Data Monitoring Committee after completion of first interim analysis as primary objective was met.)
First Posted : February 12, 2014
Results First Posted : May 10, 2022
Last Update Posted : May 13, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Arterial Hypertension | Drug: sildenafil citrate | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 385 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) |
Actual Study Start Date : | September 22, 2014 |
Actual Primary Completion Date : | February 26, 2021 |
Actual Study Completion Date : | February 26, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Low dose |
Drug: sildenafil citrate
sildenafil citrate (PDE-5 inhibitor) 5 mg tablet TID until study treatment discontinued or end of study
Other Name: Revatio |
Experimental: Medium dose |
Drug: sildenafil citrate
sildenafil citrate (PDE-5 inhibitor) 20 mg tablet TID until study treatment discontinued or end of study
Other Name: Revatio |
Experimental: High dose |
Drug: sildenafil citrate
sildenafil citrate (PDE-5 inhibitor) 80 mg tablet TID until study treatment discontinued or end of study
Other Name: Revatio |
- Overall Survival [ Time Frame: Day 1 of study treatment up to date of death (within a maximum duration of 2102 days) ]In this outcome measure number of deaths during the study were reported.
- Number of Participants With Clinical Worsening Events [ Time Frame: Day 1 of study treatment up to date of clinical worsening event (within a maximum duration of 2080 days) ]Clinical worsening was defined as all-cause mortality, non-elective hospital stay for worsening pulmonary arterial hypertension (PAH) (including but not limited to right heart failure [RHF], initiation of intravenous (IV) prostanoids, lung transplantation, or septostomy) or disease progression. Disease progression was defined as a reduction from baseline in the 6-Minute Walk Distance (6MWD) test by 15% and worsening functional class from baseline, both confirmed by second test within 2 weeks of study treatment.
- Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 6 [ Time Frame: Baseline, Month 6 ]6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Analysis was performed using mixed model for repeated measures (MMRM), adjusted for baseline 6MWD and for randomization stratification factors: PAH treatment at study entry and etiology of PAH.
- Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 12 [ Time Frame: Baseline, Month 12 ]6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Analysis was performed using mixed model for repeated measures (MMRM), adjusted for baseline 6MWD and for randomization stratification factors: PAH treatment at study entry and etiology of PAH.

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Ages Eligible for Study: | 18 Years to 74 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060487

Study Director: | Pfizer CT.gov Call Center | Pfizer |
Documents provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
Responsible Party: | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
ClinicalTrials.gov Identifier: | NCT02060487 |
Other Study ID Numbers: |
A1481324 2013-004362-34 ( EudraCT Number ) AFFILIATE ( Other Identifier: Alias Study Number ) |
First Posted: | February 12, 2014 Key Record Dates |
Results First Posted: | May 10, 2022 |
Last Update Posted: | May 13, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. |
URL: | https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
pulmonary arterial hypertension pulmonary hypertension PAH sildenafil revatio |
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