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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
A Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial Hypertension
Secondary ID [1] 0 0
FPH03
Secondary ID [2] 0 0
B1321007
Universal Trial Number (UTN)
Trial acronym
STRIDE-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sitaxsentan

Experimental: Sitaxsentan - Sitaxsentan


Treatment: Drugs: Sitaxsentan
Sitaxsentan 100 mg tablets once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Day 1 up to 82 months
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)
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
Primary outcome [3] 0 0
The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN
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
Primary outcome [4] 0 0
Percentage of Participants With Total Bilirubin > 1.5 x ULN
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
Primary outcome [5] 0 0
Percentage of Participants With Laboratory Test Abnormalities (Hematology)
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
Primary outcome [6] 0 0
Percentage of Participants With Laboratory Test Abnormalities (Chemistry)
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
Primary outcome [7] 0 0
Percentage of Participants With Laboratory Test Abnormalities (Urinalysis)
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
Primary outcome [8] 0 0
Percentage of Participants With Anticoagulant Use
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
Primary outcome [9] 0 0
Percentage of Participants With Elevated International Normalize Ratio (INR)
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
Primary outcome [10] 0 0
Percentage of Participants With Electrocardiography (ECG) Results of Potential Clinical Importance
Timepoint [10] 0 0
Weeks 28,60,72,84,96,104, Transition Visit up to 82 months
Primary outcome [11] 0 0
Percentage of Participants With Vital Sign Results of Potential Clinical Importance
Timepoint [11] 0 0
Day 1, Weeks 28,60,72,84,96,104, Transition visit, every 6 months Post Transition, up to 82 months
Primary outcome [12] 0 0
Percentage of Participants With Abnormal Prothrombin Time (PT)
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
Primary outcome [13] 0 0
Percentage of Participants With Abnormal Partial Thromboplastin Time (PTT)
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

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.
Minimum age
12 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Has portal hypertension or chronic liver disease.

- Has history of left sided heart disease or significant cardiac disease.

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2011
Sample size
Target
Accrual to date
Final
1192
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Chermside Q
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Melbourne
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Chermside
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4032 - Chermside Q
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
QLD 4032 - Chermside
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maine
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Minnesota
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Utah
Country [25] 0 0
United States of America
State/province [25] 0 0
Wisconsin
Country [26] 0 0
Argentina
State/province [26] 0 0
Buenos Aires
Country [27] 0 0
Argentina
State/province [27] 0 0
Capital Federal
Country [28] 0 0
Austria
State/province [28] 0 0
Graz
Country [29] 0 0
Austria
State/province [29] 0 0
Wien
Country [30] 0 0
Belgium
State/province [30] 0 0
Bruxelles
Country [31] 0 0
Belgium
State/province [31] 0 0
Leuven
Country [32] 0 0
Brazil
State/province [32] 0 0
MG
Country [33] 0 0
Brazil
State/province [33] 0 0
RS
Country [34] 0 0
Brazil
State/province [34] 0 0
Sao Paulo
Country [35] 0 0
Canada
State/province [35] 0 0
Alberta
Country [36] 0 0
Canada
State/province [36] 0 0
British Columbia
Country [37] 0 0
Canada
State/province [37] 0 0
Ontario
Country [38] 0 0
Canada
State/province [38] 0 0
Quebec
Country [39] 0 0
France
State/province [39] 0 0
Clamart Cedex
Country [40] 0 0
France
State/province [40] 0 0
GRENOBLE Cedex 09
Country [41] 0 0
France
State/province [41] 0 0
Strasbourg
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Germany
State/province [42] 0 0
Berlin
Country [43] 0 0
Germany
State/province [43] 0 0
Dresden
Country [44] 0 0
Germany
State/province [44] 0 0
Giessen
Country [45] 0 0
Germany
State/province [45] 0 0
Greifswald
Country [46] 0 0
Germany
State/province [46] 0 0
Hannover
Country [47] 0 0
Germany
State/province [47] 0 0
Heidelberg
Country [48] 0 0
Germany
State/province [48] 0 0
Leipzig
Country [49] 0 0
Germany
State/province [49] 0 0
Regensburg
Country [50] 0 0
Israel
State/province [50] 0 0
Petach Tikva
Country [51] 0 0
Israel
State/province [51] 0 0
Tel-Hashomer, Ramat Gan
Country [52] 0 0
Italy
State/province [52] 0 0
Bologna
Country [53] 0 0
Mexico
State/province [53] 0 0
CP
Country [54] 0 0
Mexico
State/province [54] 0 0
DF
Country [55] 0 0
Mexico
State/province [55] 0 0
N.l.
Country [56] 0 0
Netherlands
State/province [56] 0 0
Amsterdam
Country [57] 0 0
Poland
State/province [57] 0 0
Krakow
Country [58] 0 0
Poland
State/province [58] 0 0
Warszawa
Country [59] 0 0
Poland
State/province [59] 0 0
Zabrze
Country [60] 0 0
Spain
State/province [60] 0 0
Barcelona
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Cambridgeshire
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Glasgow
Country [63] 0 0
United Kingdom
State/province [63] 0 0
London
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Newcastle

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00811018
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00811018