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Trial record 1 of 1 for:    NCT01365585
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Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ≥20mg TID For The Treatment Of Pulmonary Arterial Hypertension

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ClinicalTrials.gov Identifier: NCT01365585
Recruitment Status : Completed
First Posted : June 3, 2011
Results First Posted : October 31, 2012
Last Update Posted : February 1, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date June 1, 2011
First Posted Date June 3, 2011
Results First Submitted Date October 5, 2012
Results First Posted Date October 31, 2012
Last Update Posted Date February 1, 2021
Study Start Date July 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 5, 2012)
  • Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 1 [ Time Frame: Baseline, Year 1 ]
    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.
  • Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 2 [ Time Frame: Baseline, Year 2 ]
    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.
  • Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 3 [ Time Frame: Baseline, Year 3 ]
    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.
  • Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 4 [ Time Frame: Baseline, Year 4 ]
    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.
Original Primary Outcome Measures
 (submitted: June 1, 2011)
Mean change in 6-minute walk distance (6MWD) [ Time Frame: Study Index to Subsequent Visits ]
Change History
Current Secondary Outcome Measures
 (submitted: October 5, 2012)
  • Change From Baseline in New York Heart Association, World Health Organization (NYHA/WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Year 1, 2, 3 and 4 [ Time Frame: Baseline, Year 1, 2, 3, 4 ]
    NYHA/WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (can not perform a physical activity without any symptoms, dyspnea at rest). Improvement=reduction in functional class, deterioration = increase in functional class, no change = no change in functional class. Number of participants in each functional class was reported.
  • Change From Baseline in Right Atrial Pressure (RAP) at Year 1, 2, 3 and 4 [ Time Frame: Baseline, Year 1, 2, 3, 4 ]
    RAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.
  • Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Rest at Year 1, 2, 3 and 4 [ Time Frame: Baseline, Year 1, 2, 3, 4 ]
    mPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.
  • Change From Baseline in Pulmonary Vascular Resistance (PVR) at Year 1, 2, 3 and 4 [ Time Frame: Baseline, Year 1, 2, 3, 4 ]
    PVR: calculated by subtracting PCWP from mPAP and dividing by cardiac output in pulmonary circulation (COpulm).
  • Change From Baseline in Cardiac Index (CI) at Year 1, 2, 3 and 4 [ Time Frame: Baseline, Year 1, 2, 3, 4 ]
    CI: calculated as COsys divided by BSA.
  • Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Year 1, 2, 3 and 4 [ Time Frame: Baseline, Year 1, 2, 3, 4 ]
    PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.
  • Change From Baseline in Borg Dyspnea Index at Year 1, 2, 3 and 4 [ Time Frame: Baseline, Year 1, 2, 3, 4 ]
    Borg dyspnea scale: 10-point scale where following scores stands for severity of dyspnea: 0=no breathlessness at all;0.5=very very slight (just noticeable); 1=very slight; 2=slight breathlessness; 3=moderate; 4=some what severe; 5=severe; 7=very severe breathlessness; 9=very very severe (almost maximum) and 10=maximum.
Original Secondary Outcome Measures
 (submitted: June 1, 2011)
  • Mean change in World Health Organization (WHO) functional class [ Time Frame: Study Index to Subsequent Visits ]
  • Mean change in right atrial pressure (RAP) [ Time Frame: Study Index to Subsequent Visits ]
  • Mean change in pulmonary arterial pressure at rest (mPAP) [ Time Frame: Study Index to Subsequent Visits ]
  • Mean change in pulmonary vascular resistance (PVR) [ Time Frame: Study Index to Subsequent Visits ]
  • Mean change in cardiac index (CI) [ Time Frame: Study Index to Subsequent Visits ]
  • Mean change in pulmonary capillary wedge pressure (PCWP) [ Time Frame: Study Index to Subsequent Visits ]
  • Mean change in Borg Dyspnea Index [ Time Frame: Study Index to Subsequent Visits ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ≥20mg TID For The Treatment Of Pulmonary Arterial Hypertension
Official Title Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ≥20mg TID For The Treatment Of Pulmonary Arterial Hypertension
Brief Summary The objective of this observational study is to gain clinical insight on the actual use of sildenafil citrate (Revatio™) for the treatment of pulmonary arterial hypertension (PAH). The primary objective is to assess effectiveness and safety of sildenafil at doses ≥20mg three times daily for the treatment of PAH.
Detailed Description The study design proposed is a retrospective chart review going back five years (01 April 2006 estimate) from the time of study initiation (31 March 2011 estimate). Within this five-year period, study index will occur the first time an adult patient begins sildenafil for the treatment of PAH for a period of at least three months. The patient has to be taking sildenafil at doses ≥ 20mg tid for the treatment of PAH.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients at least 18 years of age diagnosed with pulmonary arterial hypertension (PAH; per Dana Point classification) and treated with sildenafil citrate for their PAH
Condition Pulmonary Arterial Hypertension
Intervention Drug: sildenafil citrate
Sildenafil citrate, 20mg oral tablets, taken at least three times daily
Study Groups/Cohorts Sildenafil ≥20mg three times daily
Subjects receiving sildenafil ≥20mg three times daily for the treatment of PAH
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 Completed
Actual Enrollment
 (submitted: January 8, 2013)
227
Original Estimated Enrollment
 (submitted: June 1, 2011)
400
Actual Study Completion Date October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients must be at least 18 years of age at study index;
  • Patients must have a diagnosis of PAH. PAH is conventionally defined as a mean pulmonary arterial pressure (PAP) of > 25 mmHg and a pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg and a pulmonary vascular resistance (PVR) ≥ 240 dynes/s/cm-5 at right heart catheterization;
  • Patients must have initiated sildenafil for the treatment of their PAH; at dose ≥ 20 mg tid within 5 years prior to study initiation

Exclusion Criteria:

  • Patient has known contraindications to sildenafil at study index;
  • Patient participated in an investigational study of sildenafil treatment for PAH during the period beginning 6 months prior to study index
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany,   Ireland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01365585
Other Study ID Numbers A1481297
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2021