Official Title: “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)

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2009

Intervention(s) in this Clinical Trial

• Drug: sildenafil citrate
  • UK-92,480

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: sildenafil citrate
  • sildenafil citrate 20 mg TID

Primary Measures

• Change from baseline at Week 12 in haemodynamics parameters: mean pulmonary arterial pressure (mPAP), pulmonary vascular resistance (PVR) and cardiac output (CO)
  • Time Frame: 3 months
    Safety Issue?: No
• The incidence of all adverse events
  • Time Frame: End of study
    Safety Issue?: Yes
• Change from baseline in the total distance walked during the 6-Minute Walk test at Week 12
  • Time Frame: 3 months
    Safety Issue?: No
• Abnormal laboratory changes
  • Time Frame: End of study
    Safety Issue?: Yes
• Vital signs changes
  • Time Frame: End of study
    Safety Issue?: Yes

Secondary Measures

• Change from baseline at Week 12 in the additional haemodynamics parameters: PAP (systolic, diastolic), systemic blood pressure (systolic, diastolic, mean), PCWP, RAP, CI, heart rate, PVRI, SVR, SVRI, SvO2, SaO2, PaO2, PvO2
  • Time Frame: 3 months
    Safety Issue?: No
• Change from baseline at Week 8 and 12 in the BORG dyspnoea score
  • Time Frame: 3 months
    Safety Issue?: No
• Change from baseline at Week 4, 8 and 12 in WHO function classification
  • Time Frame: 3 months
    Safety Issue?: No
• Change from baseline at Week 4, 8 and 12 in the BNP
  • Time Frame: 3 months
    Safety Issue?: No
• Pharmacokinetics: PK parameters of sildenafil and its metabolite, UK-103,320, at steady state following sildenafil administration; Tmax, Cmax and AUC0-t
  • Time Frame: End of study
    Safety Issue?: No
• Change from baseline in the total distance walked during the 6-Minute Walk test at Week 8
  • Time Frame: 2 months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00454207

Study ID Number: A1481252

ClinicalTrials.gov Identifier: NCT00454207

Health Authority: Japan: Ministry of Health, Labor and Welfare

To obtain contact information for a study center near you, click here.