Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension
NCT00454207
ABOUT THIS STUDY
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- Subjects aged 16 and over, and classified as having pulmonary arterial hypertension
- Subjects who meet the following conditions on right heart catheterization at screening or baseline: mean pulmonary arterial pressure of ≥ 25mmHg and pulmonary capillary wedge pressure of ≤ 15mmHg at rest
- Subjects whose baseline 6-Minute Walk test distance is >100 m and <450 m
- Significant Hepatic and/or renal disorder
- Subjects with known hereditary degenerative retinal disorders (such as retinitis
pigmentosa) or history of non-arteritic ischemic optic neuropathy (NAION)
- Subjects who are currently receiving nitrates or nitric oxide donors in any form,
ritonavir, ketoconazole and itraconazole
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension | |||
Official Title ICMJE | A Phase 3, Multi-Center, Open-Label Study to Assess Safety and Efficacy of Sildenafil Citrate 20 mg TID in Subjects With Pulmonary Arterial Hypertension | |||
Brief Summary | To assess the safety of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1 and 2) To assess the efficacy after 12 weeks of treatment of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1) | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Pulmonary Hypertension | |||
Intervention ICMJE | Drug: sildenafil citrate (UK-92,480)
sildenafil citrate (UK-92,480) | |||
Study Arms ICMJE | Experimental: sildenafil citrate (UK-92,480)
sildenafil citrate 20 mg TID Intervention: Drug: sildenafil citrate (UK-92,480) | |||
Publications * | Not Provided | |||
* 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 | Completed | |||
Actual Enrollment ICMJE | 44 | |||
Original Enrollment ICMJE | 20 | |||
Actual Study Completion Date ICMJE | February 2009 | |||
Actual Primary Completion Date | February 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 16 Years and older (Child, 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 | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00454207 | |||
Other Study ID Numbers ICMJE | A1481252 JapicCTI-070381 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | August 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |