Clinical trial NCT00454207: Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Hypertension
Keywords: Pulmonary Arterial Hypertension, PAH
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-30
Enrollment: 44
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Entered the Study From Part I
timeFrame: Baseline, Week 12
measure: Change in the Mean Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
timeFrame: Baseline, Week 12
measure: Change in the Pulmonary Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I
timeFrame: Baseline, Week 12
measure: Change in the Cardiac Output From Baseline at Week 12 in Participants Who Entered the Study From Part I
timeFrame: Baseline, week 12
Secondary outcomes:
measure: Change in the 6-minute Walk Distance From Baseline at Week 8 in Participants Who Entered the Study From Part I
timeFrame: Baseline, Week 8
measure: Change in the Systolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
timeFrame: Baseline, Week 12
measure: Change in the Diastolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
timeFrame: Baseline, Week 12
measure: Change in the Systolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
timeFrame: Baseline, Week 12
measure: Change in the Diastolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
timeFrame: Baseline, Week 12
measure: Change in the Mean Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
timeFrame: Baseline, Week 12
measure: Change in the Pulmonary Capillary Wedge Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
timeFrame: Baseline, Week 12
measure: Change in the Right Atrial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
timeFrame: Baseline, Week 12
measure: Change in the Cardiac Index From Baseline at Week 12 in Participants Who Entered the Study From Part I
timeFrame: Baseline, Week 12
measure: Change in the Heart Rate From Baseline at Week 12 in Participants Who Entered the Study From Part I
timeFrame: Baseline, Week 12
measure: Change in the Pulmonary Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I
timeFrame: Baseline, Week 12
measure: Change in the Systemic Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I
timeFrame: Baseline, Week 12
measure: Change in the Systemic Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I
timeFrame: baseline, Week 12
measure: Change in the Mixed Venous Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I
timeFrame: Baseline, Week 12
measure: Change in the Arterial Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I
timeFrame: Baseline, Week 12
measure: Change in the Arterial Oxygen Partial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
timeFrame: baseline, Week 12
measure: Change in the Partial Pressure of Mixed Venous Oxygen From Baseline at Week 12 in Participants Who Entered the Study From Part I
timeFrame: Baseline, Week 12
measure: Changes in the World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension From Baseline at Weeks 12 in Participants Who Entered the Study From Part I
timeFrame: Baseline, Week 12
measure: Changes in the BORG Dyspnoea Score From Baseline at Week 8 and Week 12 in Participants Who Entered the Study From Part I
timeFrame: Baseline, Week 8, Week 12
measure: Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 4, Week 8 and Week 12 in Participants Who Entered the Study From Part I
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II
timeFrame: Baseline, Week 12
measure: Change in the World Health Organization (WHO) Functional Class From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II
timeFrame: Baseline, Week 12
measure: Changes in the BORG Dyspnoea Score From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II
timeFrame: Baseline, Week 12
measure: Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 12 in Participants Who Newly Enterd the Study From Part II
timeFrame: Baseline, Week 12
measure: Maximum Plasma Concentrations (Cmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing
measure: Time to First Occurrence of Maximum Plasma Concentrations (Tmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing
measure: The Area Under the Curve (AUC) From Time 0 to Time 8 Hour of Sildenafil and Sildenafil's Metabolite, UK-103,320
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing
measure: The Average Plasma Concentration (Css,av) of Sildenafil at Steady State
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing
measure: The Average Plasma Trough Concentration (Ctrough) of Sildenafil
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing
measure: Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
timeFrame: Baseline up to 1.3 years
Other outcomes:
Locations:
city: Chiba-shi
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Kanazawa
country: Japan
facility: Pfizer Investigational Site
state: Ishikawa
city: Tsu-shi
country: Japan
facility: Pfizer Investigational Site
state: Mie
city: Okayama City
country: Japan
facility: Pfizer Investigational Site
state: Okayama
city: Hamamatsu-shi
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Tokyo
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: