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


Tracking Information

Start Date  ICMJEApril 2008
Estimated Primary Completion DateDecember 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: January 22, 2008)
The change from baseline in the total distance walked during the 6MWT at Week 12 of the study. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
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 HistoryComplete list of historical versions of study NCT00430716 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: January 22, 2008)
  • Change from baseline at Week 12 in the pulmonary hypertension criteria for functional capacity and therapeutic class. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline at Week 12 in BNP and pro-BNP levels. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline at Week 12 in the BORG dyspnoea score. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline at Week 12 in mean pulmonary artery pressure (mPAP). [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
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).

Descriptive Information

Brief Title  ICMJETo Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.
Official Title  ICMJEA Multinational, Multicentre, Randomized, Parallel Group, Double-Blind Study To Assess The Efficacy and Safety Of 1 mg, 5 mg 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 
Study PhasePhase IV
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEPulmonary 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 / Comparison Groups
  • Sildenafil High dose: Experimental
    Intervention: Drug: Sildenafil citrate
  • Sildenafil Low dose: Experimental
    Intervention: Drug: Sildenafil citrate
  • Sildenafil medium dose: Experimental
    Intervention: Drug: Sildenafil citrate
  • Sildenafil - Open label Phase: Experimental
    Open label extension from week 12 to week 24.
    Intervention: Drug: Sildenafil citrate

Recruitment Information

Estimated Enrollment  ICMJE219
Estimated Completion DateDecember 2011
Estimated Primary Completion DateDecember 2011   (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).
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021
Location Countries  ICMJEUnited States,   Brazil,   Bulgaria,   China,   Greece,   India,   Italy,   Latvia,   Malaysia,   Netherlands,   Philippines,   Poland,   Romania,   Russian Federation,   Thailand,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00430716
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer Inc
Study ID Numbers  ICMJEA1481244
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer