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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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) - All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.
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) - ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
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 - ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
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 - Total builirubin data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
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) - Hematology data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
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) - Chemistry data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
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) - Urinalysis data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
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 - Participants with anticoagulant use before first dose or participants with anticoagulant use from first dose of sitaxsentan.
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) - 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.
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 - Standard 12-lead ECG results determined to be of potential clinical importance according to investigator clinical judgement.
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 - Vital signs include sitting blood pressure, respiration rate, heart rate and temperature. Potential clinical importance determined according to investigator clinical judgement.
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) - PT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
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) - PTT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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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/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/show/NCT00811018