Phase 3
Completed N=44
Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension
Source: ClinicalTrials.gov NCT00454207 ↗Enrolled (actual)
44
Serious AEs
15.9%
Results posted
Sep 2010
Primary outcomePrimary: Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Entered the Study From Part I — 84.2 meters
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Entered the Study From Part I |
84.2 | — |
| PRIMARY Change in the Mean Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I |
-4.7 | — |
| PRIMARY Change in the Pulmonary Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I |
-246.49 | — |
| PRIMARY Change in the Cardiac Output From Baseline at Week 12 in Participants Who Entered the Study From Part I |
0.556 | — |
| SECONDARY Change in the 6-minute Walk Distance From Baseline at Week 8 in Participants Who Entered the Study From Part I |
87.5 | — |
| SECONDARY Change in the Systolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I |
-3.4 | — |
| SECONDARY Change in the Diastolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I |
-3.2 | — |
| SECONDARY Change in the Systolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I |
0.7 | — |
| SECONDARY Change in the Diastolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I |
-3.1 | — |
| SECONDARY Change in the Mean Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I |
-0.9 | — |
| SECONDARY Change in the Pulmonary Capillary Wedge Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I |
0.68 | — |
| SECONDARY Change in the Right Atrial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I |
-0.3 | — |
| SECONDARY Change in the Cardiac Index From Baseline at Week 12 in Participants Who Entered the Study From Part I |
0.32 | — |
| SECONDARY Change in the Heart Rate From Baseline at Week 12 in Participants Who Entered the Study From Part I |
-4.14 | — |
| SECONDARY Change in the Pulmonary Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I |
-382.00 | — |
| SECONDARY Change in the Systemic Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I |
-265.77 | — |
| SECONDARY Change in the Systemic Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I |
-409.89 | — |
| SECONDARY Change in the Mixed Venous Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I |
2.91 | — |
| SECONDARY Change in the Arterial Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I |
0.440 | — |
| SECONDARY Change in the Arterial Oxygen Partial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I |
-2.02 | — |
| SECONDARY Change in the Partial Pressure of Mixed Venous Oxygen From Baseline at Week 12 in Participants Who Entered the Study From Part I |
0.57 | — |
| SECONDARY 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 |
0; 1; 6; 5; 1; 7 | — |
| SECONDARY Changes in the BORG Dyspnoea Score From Baseline at Week 8 and Week 12 in Participants Who Entered the Study From Part I |
-0.84; -0.95 | — |
| SECONDARY 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 |
-78.00; -88.25; -61.82 | — |
| SECONDARY Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II |
-23.5 | — |
| SECONDARY Change in the World Health Organization (WHO) Functional Class From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II |
1; 0; 0; 5; 0; 1 | — |
| SECONDARY Changes in the BORG Dyspnoea Score From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II |
0.33 | — |
| SECONDARY Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 12 in Participants Who Newly Enterd the Study From Part II |
15.91 | — |
| SECONDARY Maximum Plasma Concentrations (Cmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320 |
164.88; 87.27 | — |
| SECONDARY Time to First Occurrence of Maximum Plasma Concentrations (Tmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320 |
1.102; 1.611 | — |
| SECONDARY The Area Under the Curve (AUC) From Time 0 to Time 8 Hour of Sildenafil and Sildenafil's Metabolite, UK-103,320 |
545.14; 365.85 | — |
| SECONDARY The Average Plasma Concentration (Css,av) of Sildenafil at Steady State |
68.14 | — |
| SECONDARY The Average Plasma Trough Concentration (Ctrough) of Sildenafil |
19.608 | — |
| SECONDARY Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) |
35 | — |
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
Data sourced from ClinicalTrials.gov (NCT00454207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.