To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension
Tracking Information| Start Date ICMJE | April 2008 |
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| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) |
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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 ] |
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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. |
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| Change History | Complete list of historical versions of study NCT00430716 on ClinicalTrials.gov Archive Site |
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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 ]
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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).
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Descriptive Information| Brief Title ICMJE | To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension. |
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| Official Title ICMJE | A 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) |
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| 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. |
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| Detailed Description | |
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| Study Phase | Phase IV |
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| Study Type ICMJE | Interventional |
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| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
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| Condition ICMJE | Pulmonary Arterial Hypertension |
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| 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
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| 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
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Recruitment Information| Estimated Enrollment ICMJE | 219 |
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| Estimated Completion Date | December 2011 |
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| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) |
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| 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).
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| Gender | Both |
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| Ages | 18 Years and older |
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| Accepts Healthy Volunteers | No |
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| Contacts ICMJE | | Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | | |
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| Location Countries ICMJE | United States, Brazil, Bulgaria, China, Greece, India, Italy, Latvia, Malaysia, Netherlands, Philippines, Poland, Romania, Russian Federation, Thailand, United Kingdom |
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Administrative Information| NCT ID ICMJE | NCT00430716 |
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| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer Inc |
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| Study ID Numbers ICMJE | A1481244 |
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| Study Sponsor ICMJE | Pfizer |
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| Collaborators ICMJE | |
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| Investigators ICMJE | | Study Director: | Pfizer CT.gov Call Center | Pfizer | |
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| Information Provided By | Pfizer |
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