Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension

NCT00454207

Last updated date
Study Location
Pfizer Investigational Site
Chiba-shi, Chiba, , Japan
Contact
1-800-718-1021

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
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
 (submitted: August 18, 2010)
44
Original Enrollment  ICMJE
 (submitted: March 28, 2007)
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:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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