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Effects of Oral Sildenafil on Mortality in Adults With PAH (AFFILIATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: sildenafil citrate Phase 4

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
Study Protocol  [PDF] August 28, 2020
Statistical Analysis Plan  [PDF] March 24, 2021

More Information
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Additional Information:

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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
pulmonary arterial hypertension
pulmonary hypertension
PAH
sildenafil
revatio
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Sildenafil Citrate
Citric Acid
Sodium Citrate
 Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents