Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00811018
Registration number
NCT00811018
Ethics application status
Date submitted
9/12/2008
Date registered
18/12/2008
Date last updated
24/04/2012
Titles & IDs
Public title
A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension
Query!
Scientific title
A Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial Hypertension
Query!
Secondary ID [1]
0
0
FPH03
Query!
Secondary ID [2]
0
0
B1321007
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
STRIDE-3
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Human Genetics and Inherited Disorders
0
0
0
0
Query!
Other human genetics and inherited disorders
Query!
Cardiovascular
0
0
0
0
Query!
Hypertension
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Sitaxsentan
Experimental: Sitaxsentan - Sitaxsentan
Treatment: Drugs: Sitaxsentan
Sitaxsentan 100 mg tablets once daily
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Query!
Assessment method [1]
0
0
All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.
Query!
Timepoint [1]
0
0
Day 1 up to 82 months
Query!
Primary outcome [2]
0
0
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)
Query!
Assessment method [2]
0
0
ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Query!
Timepoint [2]
0
0
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
Query!
Primary outcome [3]
0
0
The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN
Query!
Assessment method [3]
0
0
ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Query!
Timepoint [3]
0
0
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
Query!
Primary outcome [4]
0
0
Percentage of Participants With Total Bilirubin > 1.5 x ULN
Query!
Assessment method [4]
0
0
Total builirubin data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Query!
Timepoint [4]
0
0
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
Query!
Primary outcome [5]
0
0
Percentage of Participants With Laboratory Test Abnormalities (Hematology)
Query!
Assessment method [5]
0
0
Hematology data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Query!
Timepoint [5]
0
0
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
Query!
Primary outcome [6]
0
0
Percentage of Participants With Laboratory Test Abnormalities (Chemistry)
Query!
Assessment method [6]
0
0
Chemistry data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Query!
Timepoint [6]
0
0
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
Query!
Primary outcome [7]
0
0
Percentage of Participants With Laboratory Test Abnormalities (Urinalysis)
Query!
Assessment method [7]
0
0
Urinalysis data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Query!
Timepoint [7]
0
0
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
Query!
Primary outcome [8]
0
0
Percentage of Participants With Anticoagulant Use
Query!
Assessment method [8]
0
0
Participants with anticoagulant use before first dose or participants with anticoagulant use from first dose of sitaxsentan.
Query!
Timepoint [8]
0
0
Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
Query!
Primary outcome [9]
0
0
Percentage of Participants With Elevated International Normalize Ratio (INR)
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
Query!
Primary outcome [10]
0
0
Percentage of Participants With Electrocardiography (ECG) Results of Potential Clinical Importance
Query!
Assessment method [10]
0
0
Standard 12-lead ECG results determined to be of potential clinical importance according to investigator clinical judgement.
Query!
Timepoint [10]
0
0
Weeks 28,60,72,84,96,104, Transition Visit up to 82 months
Query!
Primary outcome [11]
0
0
Percentage of Participants With Vital Sign Results of Potential Clinical Importance
Query!
Assessment method [11]
0
0
Vital signs include sitting blood pressure, respiration rate, heart rate and temperature. Potential clinical importance determined according to investigator clinical judgement.
Query!
Timepoint [11]
0
0
Day 1, Weeks 28,60,72,84,96,104, Transition visit, every 6 months Post Transition, up to 82 months
Query!
Primary outcome [12]
0
0
Percentage of Participants With Abnormal Prothrombin Time (PT)
Query!
Assessment method [12]
0
0
PT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Query!
Timepoint [12]
0
0
Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
Query!
Primary outcome [13]
0
0
Percentage of Participants With Abnormal Partial Thromboplastin Time (PTT)
Query!
Assessment method [13]
0
0
PTT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Query!
Timepoint [13]
0
0
Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
Query!
Eligibility
Key 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.
Query!
Minimum age
12
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Has portal hypertension or chronic liver disease.
* Has history of left sided heart disease or significant cardiac disease.
Query!
Study design
Purpose of the study
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/03/2003
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/07/2011
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1192
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
Pfizer Investigational Site - Darlinghurst
Query!
Recruitment hospital [2]
0
0
Pfizer Investigational Site - Chermside Q
Query!
Recruitment hospital [3]
0
0
Pfizer Investigational Site - Melbourne
Query!
Recruitment hospital [4]
0
0
Pfizer Investigational Site - Chermside
Query!
Recruitment postcode(s) [1]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [2]
0
0
4032 - Chermside Q
Query!
Recruitment postcode(s) [3]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [4]
0
0
QLD 4032 - Chermside
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kansas
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kentucky
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Louisiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Maine
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maryland
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Massachusetts
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Michigan
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Minnesota
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New Jersey
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New York
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
North Carolina
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Ohio
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Pennsylvania
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
South Carolina
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Tennessee
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Texas
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Utah
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Wisconsin
Query!
Country [26]
0
0
Argentina
Query!
State/province [26]
0
0
Buenos Aires
Query!
Country [27]
0
0
Argentina
Query!
State/province [27]
0
0
Capital Federal
Query!
Country [28]
0
0
Austria
Query!
State/province [28]
0
0
Graz
Query!
Country [29]
0
0
Austria
Query!
State/province [29]
0
0
Wien
Query!
Country [30]
0
0
Belgium
Query!
State/province [30]
0
0
Bruxelles
Query!
Country [31]
0
0
Belgium
Query!
State/province [31]
0
0
Leuven
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
MG
Query!
Country [33]
0
0
Brazil
Query!
State/province [33]
0
0
RS
Query!
Country [34]
0
0
Brazil
Query!
State/province [34]
0
0
Sao Paulo
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
Alberta
Query!
Country [36]
0
0
Canada
Query!
State/province [36]
0
0
British Columbia
Query!
Country [37]
0
0
Canada
Query!
State/province [37]
0
0
Ontario
Query!
Country [38]
0
0
Canada
Query!
State/province [38]
0
0
Quebec
Query!
Country [39]
0
0
France
Query!
State/province [39]
0
0
Clamart Cedex
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
GRENOBLE Cedex 09
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Strasbourg
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Berlin
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
Dresden
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Giessen
Query!
Country [45]
0
0
Germany
Query!
State/province [45]
0
0
Greifswald
Query!
Country [46]
0
0
Germany
Query!
State/province [46]
0
0
Hannover
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Heidelberg
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Leipzig
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Regensburg
Query!
Country [50]
0
0
Israel
Query!
State/province [50]
0
0
Petach Tikva
Query!
Country [51]
0
0
Israel
Query!
State/province [51]
0
0
Tel-Hashomer, Ramat Gan
Query!
Country [52]
0
0
Italy
Query!
State/province [52]
0
0
Bologna
Query!
Country [53]
0
0
Mexico
Query!
State/province [53]
0
0
CP
Query!
Country [54]
0
0
Mexico
Query!
State/province [54]
0
0
DF
Query!
Country [55]
0
0
Mexico
Query!
State/province [55]
0
0
N.l.
Query!
Country [56]
0
0
Netherlands
Query!
State/province [56]
0
0
Amsterdam
Query!
Country [57]
0
0
Poland
Query!
State/province [57]
0
0
Krakow
Query!
Country [58]
0
0
Poland
Query!
State/province [58]
0
0
Warszawa
Query!
Country [59]
0
0
Poland
Query!
State/province [59]
0
0
Zabrze
Query!
Country [60]
0
0
Spain
Query!
State/province [60]
0
0
Barcelona
Query!
Country [61]
0
0
United Kingdom
Query!
State/province [61]
0
0
Cambridgeshire
Query!
Country [62]
0
0
United Kingdom
Query!
State/province [62]
0
0
Glasgow
Query!
Country [63]
0
0
United Kingdom
Query!
State/province [63]
0
0
London
Query!
Country [64]
0
0
United Kingdom
Query!
State/province [64]
0
0
Newcastle
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00811018
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00811018
Download to PDF