| To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.
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| 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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| 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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| Not Provided
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| Interventional
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| Phase 4
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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| Pulmonary Arterial Hypertension
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- 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
|
- 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
|
|
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.
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| |
| Terminated
|
| 130
|
| 174
|
| May 2010
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| May 2010 (Final data collection date for primary outcome measure)
|
|
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
- Subjects with a mean pulmonary artery pressure of >/= 25 mmHg and a pulmonary artery wedge pressure of
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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| Sexes Eligible for Study: |
All |
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| 18 Years and older (Adult, Older Adult)
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| No
|
|
Contact information is only displayed when the study is recruiting subjects
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| Belgium, Brazil, Bulgaria, China, Greece, India, Italy, Latvia, Malaysia, Netherlands, Philippines, Poland, Romania, Russian Federation, Thailand, United Kingdom, United States
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| Denmark, Panama
|
| |
| NCT00430716
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| A1481244
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| Yes
|
| Not Provided
|
| Not Provided
|
| Director, Clinical Trial Disclosure Group, Pfizer Inc
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| Pfizer
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| Not Provided
|
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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| Pfizer
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| May 2011
|
