A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension - Full Text View

Purpose

This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily by subjects with PAH until sitaxsentan, in a particular country or region, is commercially available for the treatment of PAH or the study is closed.

Condition	Intervention	Phase
Pulmonary Arterial Hypertension	Drug: Sitaxsentan	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	A Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial Hypertension

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 up to 82 months ] [ Designated as safety issue: No ]
All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.
The Percentage of Participants Who Experience an Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Value Greater Than (>) 3.0 Times (x) the Upper Limit of Normal Range (ULN) [ Time Frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months ] [ Designated as safety issue: No ]
ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN [ Time Frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months ] [ Designated as safety issue: No ]
ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Percentage of Participants With Total Bilirubin > 1.5 x ULN [ Time Frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months ] [ Designated as safety issue: No ]
Total builirubin data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Percentage of Participants With Laboratory Test Abnormalities (Hematology) [ Time Frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months ] [ Designated as safety issue: No ]
Hematology data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Percentage of Participants With Laboratory Test Abnormalities (Chemistry) [ Time Frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months ] [ Designated as safety issue: No ]
Chemistry data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Percentage of Participants With Laboratory Test Abnormalities (Urinalysis) [ Time Frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months ] [ Designated as safety issue: No ]
Urinalysis data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Percentage of Participants With Anticoagulant Use [ Time Frame: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months ] [ Designated as safety issue: No ]
Participants with anticoagulant use before first dose or participants with anticoagulant use from first dose of sitaxsentan.
Percentage of Participants With Elevated International Normalize Ratio (INR) [ Time Frame: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months ] [ Designated as safety issue: No ]
Elevated INR in participants who took warfarin, warfarin derivatives, other anticoagulant and no anticoagulants. Elevated INR defined as > 3.5. Percentage calculated using number of participants with INR data as the denominator.
Percentage of Participants With Electrocardiography (ECG) Results of Potential Clinical Importance [ Time Frame: Weeks 28,60,72,84,96,104, Transition Visit up to 82 months ] [ Designated as safety issue: No ]
Standard 12-lead ECG results determined to be of potential clinical importance according to investigator clinical judgement.
Percentage of Participants With Vital Sign Results of Potential Clinical Importance [ Time Frame: Day 1, Weeks 28,60,72,84,96,104, Transition visit, every 6 months Post Transition, up to 82 months ] [ Designated as safety issue: No ]
Vital signs include sitting blood pressure, respiration rate, heart rate and temperature. Potential clinical importance determined according to investigator clinical judgement.
Percentage of Participants With Abnormal Prothrombin Time (PT) [ Time Frame: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months ] [ Designated as safety issue: No ]
PT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Percentage of Participants With Abnormal Partial Thromboplastin Time (PTT) [ Time Frame: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months ] [ Designated as safety issue: No ]
PTT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

Enrollment:	1192
Study Start Date:	March 2003
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Sitaxsentan Sitaxsentan	Drug: Sitaxsentan Sitaxsentan 100 mg tablets once daily Other Name: Sitaxentan

Detailed Description:

Open-label extension

Eligibility

Ages Eligible for Study:	12 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of Pulmonary Arterial Hypertension (PAH) confirmed by cardiac catheterization.
Current diagnosis of WHO group 1 PAH with functional class 2, 3, or 4 symptoms.

Exclusion Criteria:

Has portal hypertension or chronic liver disease.
Has history of left sided heart disease or significant cardiac disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811018

Show 91 Study Locations

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. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00811018 History of Changes
Other Study ID Numbers:	B1321007, FPH03
Study First Received:	December 9, 2008
Results First Received:	March 29, 2012
Last Updated:	March 29, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Open-label study

Additional relevant MeSH terms:

Hypertension, Pulmonary
Hypertension
Lung Diseases

Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013

A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension (STRIDE-3)