To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.
NCT00430716
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- 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.
- 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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Descriptive Information | |||||||
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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 |
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Study Arms ICMJE |
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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 | 130 | ||||||
Original Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |
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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 |