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OpenTrials
Completed

NCT Number: NCT00454207

Open Label Study of Sildenafil in Patients 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)

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Pulmonary Arterial Hypertension Respiratory Tract Diseases Vascular Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Chiba, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sildenafil citrate (UK-92,480)

Drug

sildenafil citrate (UK-92,480)

Primary outcomes

  1. Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Entered the Study From Part I

    Time frame: Baseline, Week 12

    Change：6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:total distance walked during the 6-minute walk test.

  2. Change in the Mean Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I

    Time frame: Baseline, Week 12

    Change:Mean pulmonary arterial pressure at Week 12 minus mean pulmonary arterial pressure at baseline.

  3. Change in the Pulmonary Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I

    Time frame: Baseline, Week 12

    Change：Pulmonary vascular resistance at Week 12 minus pulmonary vascular resistance at baseline

  4. Change in the Cardiac Output From Baseline at Week 12 in Participants Who Entered the Study From Part I

    Time frame: Baseline, week 12

    Change：Cardiac output at Week 12 minus cardiac output at baseline

Secondary outcomes

  1. Change in the 6-minute Walk Distance From Baseline at Week 8 in Participants Who Entered the Study From Part I

    Time frame: Baseline, Week 8

    Change：6-minute walk distance at Week 8 minus 6-minute walk distance at baseline.

    The 6-minute walk distance:Total distance walked during the 6- minute walk test.

  2. Change in the Systolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I

    Time frame: Baseline, Week 12

    Change：Systolic pulmonary arterial pressure at Week 12 minus Systolic pulmonary arterial pressure at baseline.

  3. Change in the Diastolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I

    Time frame: Baseline, Week 12

    Change：Diastolic pulmonary arterial pressure at Week 12 minus diastolic pulmonary arterial pressure at baseline.

  4. Change in the Systolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I

    Time frame: Baseline, Week 12

    Change：Systolic systemic blood pressure at Week 12 minus systolic systemic blood pressure at baseline.

  5. Change in the Diastolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I

    Time frame: Baseline, Week 12

    Change：Diastolic systemic blood pressure at Week 12 minus diastolic systemic blood pressure at baseline.

  6. Change in the Mean Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I

    Time frame: Baseline, Week 12

    Mean systemic blood pressure:diastolic blood pressure+(systolic blood pressure-diastolic blood pressure)/3.

    Change：Mean systemic blood pressure at Week 12 minus mean systemic blood pressure at baseline.

  7. Change in the Pulmonary Capillary Wedge Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I

    Time frame: Baseline, Week 12

    Change：Pulmonary capillary wedge pressure at Week 12 minus pulmonary capillary wedge pressure at baseline.

  8. Change in the Right Atrial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I

    Time frame: Baseline, Week 12

    Change：Right atrial pressure at Week 12 minus right atrial pressure at baseline.

  9. Change in the Cardiac Index From Baseline at Week 12 in Participants Who Entered the Study From Part I

    Time frame: Baseline, Week 12

    Change：Cardiac index at Week 12 minus cardiac index at baseline.

  10. Change in the Heart Rate From Baseline at Week 12 in Participants Who Entered the Study From Part I

    Time frame: Baseline, Week 12

    Change：Heart rate at Week 12 minus heart rate at baseline.

  11. Change in the Pulmonary Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I

    Time frame: Baseline, Week 12

    Change:Pulmonary vascular resistance index at Week 12 minus pulmonary vascular resistance index at baseline.

  12. Change in the Systemic Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I

    Time frame: Baseline, Week 12

    Change：Systemic vascular resistance at Week 12 minus systemic vascular resistance at baseline.

  13. Change in the Systemic Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I

    Time frame: baseline, Week 12

    Change：Systemic vascular resistance index at Week 12 minus systemic vascular resistance index at baseline.

  14. Change in the Mixed Venous Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I

    Time frame: Baseline, Week 12

    Change：Mixed venous oxygen saturation at Week 12 minus mixed venous oxygen saturation at baseline.

  15. Change in the Arterial Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I

    Time frame: Baseline, Week 12

    Change：Arterial oxygen saturation at Week 12 minus arterial oxygen saturation at baseline.

  16. Change in the Arterial Oxygen Partial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I

    Time frame: baseline, Week 12

    Change：Arterial oxygen partial pressure at Week 12 minus arterial oxygen partial pressure at baseline.

  17. Change in the Partial Pressure of Mixed Venous Oxygen From Baseline at Week 12 in Participants Who Entered the Study From Part I

    Time frame: Baseline, Week 12

    Change：Partial pressure of mixed venous oxygen at Week 12 minus partial pressure of mixed venous oxygen at baseline.

  18. 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

    Time frame: Baseline, Week 12

    The cross-tabulation table on the WHO functional classes of pulmonary arterial hypertension at baseline and Week 12. The WHO functional classes of pulmonary arterial hypertension:Class I (pulmonary arterial hypertension patients with no limitation in physical activity) to Class IV (pulmonary arterial hypertension patients who can not perform a physical activity without any symptoms).

  19. Changes in the BORG Dyspnoea Score From Baseline at Week 8 and Week 12 in Participants Who Entered the Study From Part I

    Time frame: Baseline, Week 8, Week 12

    Change：BORG dyspnoea score at Week 8 and Week 12 minus BORG dyspnoea score at baseline. BORG dyspnoea score:Scale 0 (no breathlessness at all) to 10 (maximum). The score reflected the maximum degree of dyspnoea that the participants experienced at any time during the 6-minute walk distance.

  20. 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

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change：Plasma brain natriuretic peptide level at Week 4, Week 8 and Week 12 minus plasma brain natriuretic peptide level at baseline

  21. Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II

    Time frame: Baseline, Week 12

    Change：6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:Total distance walked during the 6- minute walk test.

  22. Change in the World Health Organization (WHO) Functional Class From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II

    Time frame: Baseline, Week 12

    The cross-tabulation table on the WHO functional classes of pulmonary arterial hypertension at baseline and Week 12. The WHO functional classes of pulmonary arterial hypertension:Class I (pulmonary arterial hypertension patients with no limitation in physical activity) to Class IV (pulmonary arterial hypertension patients who can not perform a physical activity without any symptoms).

  23. Changes in the BORG Dyspnoea Score From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II

    Time frame: Baseline, Week 12

    Change：BORG dyspnoea score at Week 12 minus BORG dyspnoea score at baseline. BORG dyspnoea score:Scale 0 (no breathlessness at all) to 10 (maximum). The score reflected the maximum degree of dyspnoea that the participants experienced at any time during the 6-minute walk distance.

  24. Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 12 in Participants Who Newly Enterd the Study From Part II

    Time frame: Baseline, Week 12

    Change：Plasma brain natriuretic peptide level at Week 12 minus plasma brain natriuretic peptide level at baseline

  25. Maximum Plasma Concentrations (Cmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing

    Maximum plasma concentrations was calculated from the observed value of plasma concentrations in each participant

  26. Time to First Occurrence of Maximum Plasma Concentrations (Tmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing

    Time to first occurrence of maximum plasma concentrations were calculated from the observed value of plasma concentrations in each participant.

  27. The Area Under the Curve (AUC) From Time 0 to Time 8 Hour of Sildenafil and Sildenafil's Metabolite, UK-103,320

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing

    The area under the curve from time 0 to time 8 hour was calculated from area under the curve in each perticipant on the date of blood sampling using the linear/log trapezoidal rule

  28. The Average Plasma Concentration (Css,av) of Sildenafil at Steady State

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing

    The average plasma concentration of sildenafil at steady state was calculated from the area under the curve from time 0 to 8 hour/dosing interval (8 hours).

  29. The Average Plasma Trough Concentration (Ctrough) of Sildenafil

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing

    The average plasma trough concentration of sildenafil was calculated from the observed value before administration of the drug in each participants.

  30. Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)

    Time frame: Baseline up to 1.3 years

    The total number of participants with laboratory test abnormalities without regard to baseline abnormality.

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 30, 2007
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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