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Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension

  Purpose

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)

Condition	Intervention	Phase
Pulmonary Hypertension	Drug: sildenafil citrate (UK-92,480)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Sodium citrate Sildenafil Sildenafil citrate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

• 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 ] [ Designated as safety issue: No ]
  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.
  
  
• 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 ] [ Designated as safety issue: No ]
  Change:Mean pulmonary arterial pressure at Week 12 minus mean pulmonary arterial pressure at baseline.
  
  
• 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 ] [ Designated as safety issue: No ]
  Change：Pulmonary vascular resistance at Week 12 minus pulmonary vascular resistance at baseline
  
  
• Change in the Cardiac Output From Baseline at Week 12 in Participants Who Entered the Study From Part I [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]
  Change：Cardiac output at Week 12 minus cardiac output at baseline
  
  

Secondary Outcome Measures:

• 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 ] [ Designated as safety issue: No ]

  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.

  
  
• 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 ] [ Designated as safety issue: No ]
  Change：Systolic pulmonary arterial pressure at Week 12 minus Systolic pulmonary arterial pressure at baseline.
  
  
• 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 ] [ Designated as safety issue: No ]
  Change：Diastolic pulmonary arterial pressure at Week 12 minus diastolic pulmonary arterial pressure at baseline.
  
  
• 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 ] [ Designated as safety issue: No ]
  Change：Systolic systemic blood pressure at Week 12 minus systolic systemic blood pressure at baseline.
  
  
• 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 ] [ Designated as safety issue: No ]
  Change：Diastolic systemic blood pressure at Week 12 minus diastolic systemic blood pressure at baseline.
  
  
• 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 ] [ Designated as safety issue: No ]

  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.

  
  
• 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 ] [ Designated as safety issue: No ]
  Change：Pulmonary capillary wedge pressure at Week 12 minus pulmonary capillary wedge pressure at baseline.
  
  
• 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 ] [ Designated as safety issue: No ]
  Change：Right atrial pressure at Week 12 minus right atrial pressure at baseline.
  
  
• Change in the Cardiac Index From Baseline at Week 12 in Participants Who Entered the Study From Part I [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  Change：Cardiac index at Week 12 minus cardiac index at baseline.
  
  
• Change in the Heart Rate From Baseline at Week 12 in Participants Who Entered the Study From Part I [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  Change：Heart rate at Week 12 minus heart rate at baseline.
  
  
• 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 ] [ Designated as safety issue: No ]
  Change:Pulmonary vascular resistance index at Week 12 minus pulmonary vascular resistance index at baseline.
  
  
• 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 ] [ Designated as safety issue: No ]
  Change：Systemic vascular resistance at Week 12 minus systemic vascular resistance at baseline.
  
  
• 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 ] [ Designated as safety issue: No ]
  Change：Systemic vascular resistance index at Week 12 minus systemic vascular resistance index at baseline.
  
  
• 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 ] [ Designated as safety issue: No ]
  Change：Mixed venous oxygen saturation at Week 12 minus mixed venous oxygen saturation at baseline.
  
  
• 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 ] [ Designated as safety issue: No ]
  Change：Arterial oxygen saturation at Week 12 minus arterial oxygen saturation at baseline.
  
  
• 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 ] [ Designated as safety issue: No ]
  Change：Arterial oxygen partial pressure at Week 12 minus arterial oxygen partial pressure at baseline.
  
  
• 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 ] [ Designated as safety issue: No ]
  Change：Partial pressure of mixed venous oxygen at Week 12 minus partial pressure of mixed venous oxygen at baseline.
  
  
• 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 ] [ Designated as safety issue: No ]
  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).
  
  
• 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 ] [ Designated as safety issue: No ]
  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.
  
  
• 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 ] [ Designated as safety issue: No ]
  Change：Plasma brain natriuretic peptide level at Week 4, Week 8 and Week 12 minus plasma brain natriuretic peptide level at baseline
  
  
• 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 ] [ Designated as safety issue: No ]
  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.
  
  
• 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 ] [ Designated as safety issue: No ]
  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).
  
  
• 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 ] [ Designated as safety issue: No ]
  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.
  
  
• 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 ] [ Designated as safety issue: No ]
  Change：Plasma brain natriuretic peptide level at Week 12 minus plasma brain natriuretic peptide level at baseline
  
  
• 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 ] [ Designated as safety issue: No ]
  Maximum plasma concentrations was calculated from the observed value of plasma concentrations in each participant
  
  
• 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 ] [ Designated as safety issue: No ]
  Time to first occurrence of maximum plasma concentrations were calculated from the observed value of plasma concentrations in each participant.
  
  
• 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 ] [ Designated as safety issue: No ]
  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
  
  
• 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 ] [ Designated as safety issue: No ]
  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).
  
  
• The Average Plasma Trough Concentration (Ctrough) of Sildenafil [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing ] [ Designated as safety issue: No ]
  The average plasma trough concentration of sildenafil was calculated from the observed value before administration of the drug in each participants.
  
  
• Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) [ Time Frame: Baseline up to 1.3 years ] [ Designated as safety issue: No ]
  The total number of participants with laboratory test abnormalities without regard to baseline abnormality.
  
  

Enrollment:	44
Study Start Date:	April 2007
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: sildenafil citrate (UK-92,480) sildenafil citrate 20 mg TID	Drug: sildenafil citrate (UK-92,480) sildenafil citrate (UK-92,480)

  Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454207

Locations

Japan

Pfizer Investigational Site

Chiba-shi, Chiba, Japan

Pfizer Investigational Site

Kanazawa, Ishikawa, Japan

Pfizer Investigational Site

Tsu-shi, Mie, Japan

Pfizer Investigational Site

Okayama City, Okayama, Japan

Pfizer Investigational Site

Hamamatsu-shi, Shizuoka, Japan

Pfizer Investigational Site

Bunkyo-ku, Tokyo, Japan

Pfizer Investigational Site

Shinjuku-ku, Tokyo, Japan

Pfizer Investigational Site

Tokyo, Japan

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

  More Information

Additional Information:

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

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer Inc.
ClinicalTrials.gov Identifier:	NCT00454207     History of Changes
Other Study ID Numbers:	A1481252, JapicCTI-070381
Study First Received:	March 28, 2007
Results First Received:	February 18, 2010
Last Updated:	August 18, 2010
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:

Pulmonary Arterial Hypertension, PAH

Additional relevant MeSH terms:

Hypertension, Pulmonary Hypertension Lung Diseases Respiratory Tract Diseases Vascular Diseases Cardiovascular Diseases Citric Acid Sildenafil Anticoagulants Hematologic Agents

Therapeutic Uses Pharmacologic Actions Chelating Agents Molecular Mechanisms of Pharmacological Action Vasodilator Agents Cardiovascular Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 17, 2013

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