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Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Chiba-shi, Chiba, Japan
Contact
1-800-718-1021
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

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

NCT00454207
Pfizer
Completed
Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension

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Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension
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
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)
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pulmonary Hypertension
Drug: sildenafil citrate (UK-92,480)
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Experimental: sildenafil citrate (UK-92,480)
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Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
February 2009
February 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00454207
A1481252
JapicCTI-070381
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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