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Trial record 1 of 1 for:    NCT02060487
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Effects of Oral Sildenafil on Mortality in Adults With PAH (AFFILIATE)

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ClinicalTrials.gov Identifier: NCT02060487
Recruitment Status : Recruiting
First Posted : February 12, 2014
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 29, 2014
First Posted Date  ICMJE February 12, 2014
Last Update Posted Date July 1, 2019
Actual Study Start Date  ICMJE September 22, 2014
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2014)
Overall Survival (OS) [ Time Frame: every 3 months up to month 96 ]
Time in weeks from the start of study treatment to date of death due to any cause. Death will be determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02060487 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2014)
  • Time to first clinical worsening (TTCW) event [ Time Frame: every 3 months up to month 96 ]
    TTCW defined as the number of days between first dose of study drug and the occurrence of a predefined clinical worsening event. Predefined clinical worsening events include: death, hospitalization due to worsening PAH or disease progression
  • 6 Minute Walk Distance (6MWD) at Months 6 & 12 [ Time Frame: Months 6 & 12 ]
    6MWD is the distance a participant can walk in 6 minutes.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
  • Drug: sildenafil citrate
    sildenafil citrate (PDE-5 inhibitor) 5 mg tablet TID until study treatment discontinued or end of study
    Other Name: Revatio
  • Drug: sildenafil citrate
    sildenafil citrate (PDE-5 inhibitor) 20 mg tablet TID until study treatment discontinued or end of study
    Other Name: Revatio
  • Drug: sildenafil citrate
    sildenafil citrate (PDE-5 inhibitor) 80 mg tablet TID until study treatment discontinued or end of study
    Other Name: Revatio
Study Arms  ICMJE
  • Experimental: Low dose
    Intervention: Drug: sildenafil citrate
  • Experimental: Medium dose
    Intervention: Drug: sildenafil citrate
  • Experimental: High dose
    Intervention: Drug: sildenafil citrate
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 10, 2014)
429
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date December 31, 2023   (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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2019

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