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To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.

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ClinicalTrials.gov Identifier: NCT00430716
Recruitment Status : Terminated (This study was terminated at the recommendation of an independent Data Monitoring Committee. The decision was not based on any safety concerns.)
First Posted : February 2, 2007
Results First Posted : May 17, 2011
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date  ICMJE January 31, 2007
First Posted Date  ICMJE February 2, 2007
Results First Submitted Date  ICMJE April 22, 2011
Results First Posted Date  ICMJE May 17, 2011
Last Update Posted Date December 22, 2020
Actual Study Start Date  ICMJE April 8, 2008
Actual Primary Completion Date May 25, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2020)
Change From Baseline in the Total Distance Walked During 6-Minute Walk Test (6MWT) at Week 12 [ Time Frame: Baseline and Week 12 ]
6 MWT 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. Continuous pulse oximetry was conducted during the test for safety.
Original Primary Outcome Measures  ICMJE
 (submitted: January 31, 2007)
The change from baseline in the total distance walked during the 6MWT at Week 12 of the study.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2020)
  • Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Week 12 [ Time Frame: Baseline and Week 12 ]
    mPAP was measured using a pressure transducer positioned at the mid-axillary line.
  • Number of Participants With Clinical Worsening [ Time Frame: Baseline through Week 12 ]
    Clinical worsening was defined as death; or lung transplantation; or hospitalization due to pulmonary hypertension; or initiation of prostacyclin therapy; or initiation of endothelin receptor antagonist therapy. (PAH=pulmonary arterial hypertension) Due to very low number of events of clinical worsening reported, the median days to clinical worsening could not be estimated.
  • Number of Participants With Change From Baseline in PAH Criteria for Functional Capacity and Therapeutic Class at Week 12 [ Time Frame: Baseline and Week 12 ]
    Pulmonary arterial hypertension (PAH) Criteria for WHO Class: Class I (Participants without resulting limitation of physical activity);Class II (Participants with slight limitation of physical activity though comfortable at rest);Class III (Participants with marked limitation of physical activity,though comfortable at rest);Class IV(Participants with inability to carry out any physical activity without symptoms,manifest signs of right heart failure; dyspnoea and/or fatigue may even be present at rest; and discomfort is increased by any physical activity).
  • Change From Baseline in B-Type Natriuretic Peptide (BNP) at Week 12 [ Time Frame: Baseline and Week 12 ]
    BNP is a non-invasive biomarker and an indicator of progression of PAH/ right ventricular dysfunction in participants with PAH.
  • Change From Baseline in Pro-BNP at Week 12 [ Time Frame: Baseline and Week 12 ]
    Pro- BNP which is a precursor of BNP, is a non-invasive biomarker and an indicator of progression of PAH / RV dysfunction in participants with PAH.
  • Change From Baseline in TAPSE Measurement at Week 12 [ Time Frame: Baseline and Week 12 ]
    Tricuspid annular plane systolic excursion (TAPSE) was measured as the total displacement of the tricuspid annulus in cm from end diastole to end systole.TAPSE is an indicator of progression of PAH /right ventricular dysfunction. The baseline data for 33 participants were measured incorrectly and the results from the 33 participants (both baseline and post-baseline) were excluded from the analysis.
  • Change From Baseline in BORG Dyspnoea Score at Week 12 [ Time Frame: Baseline and Week 12 ]
    BORG dyspnoea scale is a 10-point scale where following scores stands for severity of dyspnoea: 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 breathlessness); 7 (very severe breathlessness); 9 (very very severe [almost maximum] and 10 (maximum).
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2007)
  • Change from baseline at Week 12 in mean pulmonary artery pressure (mPAP).
  • Time from randomization to the first occurrence of clinical worsening defined as death or lung transplantation or hospitalisation due to pulmonary hypertension or initiation of prostacyclin therapy or initiation of bosentan therapy.
  • Change from baseline at Week 12 in the pulmonary hypertension criteria for functional capacity and therapeutic class. Change from baseline at Week 12 in BNP and pro-BNP levels.
  • Change from baseline at Week 12 in TAPSE measurement.Change from baseline at Week 12 in the BORG dyspnoea score.
  • Change in chronic use of background therapy for PAH: The percentage of subjects with one or more additions (from baseline) in the class(es) of drugs used as background medication (i.e. oxygen, diuretics, calcium channel blockers and digoxin).
  • AND The percentage of subjects with one or more discontinuations (from baseline) in the class(es) of drugs used as background medication (i.e. oxygen, diuretics, calcium channel blockers and digoxin).
  • The change from baseline at Week 12 in the additional haemodynamic parameters such as: cardiac output (CO), PVR, PVRI and mixed venous oxygen saturation (MVO2).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.
Official Title  ICMJE A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH)
Brief Summary To demonstrate a dose response for 1 mg, 5 mg and 20 mg TID oral sildenafil for the treatment of subjects with PAH.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Arterial Hypertension
Intervention  ICMJE
  • Drug: Sildenafil citrate
    oral, 20 mg, tid
  • Drug: Sildenafil citrate
    oral 1 mg, tid
  • Drug: Sildenafil citrate
    oral 5 mg, tid
  • Drug: Sildenafil citrate
    oral 20 mg, tid
Study Arms  ICMJE
  • Experimental: Sildenafil High dose
    Intervention: Drug: Sildenafil citrate
  • Experimental: Sildenafil Low dose
    Intervention: Drug: Sildenafil citrate
  • Experimental: Sildenafil medium dose
    Intervention: Drug: Sildenafil citrate
  • Experimental: Sildenafil - Open label Phase
    Open label extension from week 12 to week 24.
    Intervention: Drug: Sildenafil citrate
Publications * Vizza CD, Sastry BK, Safdar Z, Harnisch L, Gao X, Zhang M, Lamba M, Jing ZC. Efficacy of 1, 5, and 20 mg oral sildenafil in the treatment of adults with pulmonary arterial hypertension: a randomized, double-blind study with open-label extension. BMC Pulm Med. 2017 Feb 23;17(1):44. doi: 10.1186/s12890-017-0374-x.

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: March 9, 2011)
130
Original Enrollment  ICMJE
 (submitted: January 31, 2007)
174
Actual Study Completion Date  ICMJE May 25, 2010
Actual Primary Completion Date May 25, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with PAH (i.e. IPAH or secondary to connective tissue disease or with surgical repair of ASD, VSD, PDA, aorto-pulmonary window) whose baseline six minute walk test distance is >/= 100 m and </= 450 m.
  • Subjects with a mean pulmonary artery pressure of >/= 25 mmHg and a pulmonary artery wedge pressure of </= 15 mmHg at rest via right heart catheterization performed within 12 weeks prior to randomization.

Exclusion Criteria:

  • Subjects whose 6 Minute Walk Distance may be limited by conditions other than PAH related dyspnoea or fatigue, e.g. claudication from vascular insufficiency or significant arthritis.
  • Subjects who are currently receiving any forms of chronic treatment for PAH such as prostacyclin, PDE-5 inhibitors, endothelin-receptor antagonists, nitrates or nitric oxide donors (e.g. arginine supplement, nicorandil) in any form, protease inhibitors such as ritonavir and saquinavir, ketoconazole, itraconazole, and alpha blockers. Subjects previously receiving any of these drugs must have stopped use for a period of at least 1 month prior to screening, except in the case of bosentan or prostacyclin (3 months).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Belgium,   Brazil,   Bulgaria,   China,   Greece,   India,   Italy,   Latvia,   Malaysia,   Netherlands,   Philippines,   Poland,   Romania,   Russian Federation,   Thailand,   United Kingdom,   United States
Removed Location Countries Denmark,   Panama
 
Administrative Information
NCT Number  ICMJE NCT00430716
Other Study ID Numbers  ICMJE A1481244
2006-006748-76 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
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 ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2020

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