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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00777920




Registration number
NCT00777920
Ethics application status
Date submitted
1/07/2008
Date registered
22/10/2008
Date last updated
13/12/2019

Titles & IDs
Public title
Study of Ambrisentan in Subjects With Pulmonary Hypertension
Scientific title
ABS-LT: A Phase 3, Long-Term, Open Label, Multicenter Safety Study of Ambrisentan in Subjects With Pulmonary Hypertension
Secondary ID [1] 0 0
GS-US-300-0124
Universal Trial Number (UTN)
Trial acronym
ABS-LT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Hypertension

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

Experimental: Ambrisentan - Participants will receive ambrisentan 5 mg or 10 mg once daily.


Treatment: Drugs: Ambrisentan
Ambrisentan tablet administered orally once daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of adverse events (AEs) associated with long-term exposure to ambrisentan in participants with pulmonary hypertension - Incidence and severity of AEs will be summarized.
Timepoint [1] 0 0
Up to 9 years

Eligibility
Key inclusion criteria
- Men and women with pulmonary hypertension (PH) who are discontinuing a clinical study
of ambrisentan due to study closure by the Sponsor. Eligible subjects are those
participating in countries where ambrisentan is not yet commercially available.
Subjects participating in countries where ambrisentan is commercially available may be
eligible if they do not qualify for treatment per the current prescribing information
of that country.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects who have discontinued an ambrisentan clinical study for any other reason than
Sponsor-initiated study closure are not eligible.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Completed
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,WA
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
6000 - Perth
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
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Rhode Island
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Cordoba
Country [16] 0 0
Argentina
State/province [16] 0 0
Corrientes
Country [17] 0 0
Argentina
State/province [17] 0 0
Rosario
Country [18] 0 0
Brazil
State/province [18] 0 0
Belo Horizonte
Country [19] 0 0
Brazil
State/province [19] 0 0
Porto Alegre
Country [20] 0 0
Brazil
State/province [20] 0 0
Rio de Janeiro
Country [21] 0 0
Brazil
State/province [21] 0 0
Sao Paulo
Country [22] 0 0
Canada
State/province [22] 0 0
Alberta
Country [23] 0 0
Chile
State/province [23] 0 0
Santiago
Country [24] 0 0
Mexico
State/province [24] 0 0
Mexico City
Country [25] 0 0
Mexico
State/province [25] 0 0
Monterrey
Country [26] 0 0
Russian Federation
State/province [26] 0 0
Moscow
Country [27] 0 0
Russian Federation
State/province [27] 0 0
St. Petersburg
Country [28] 0 0
Ukraine
State/province [28] 0 0
Kharkov
Country [29] 0 0
Ukraine
State/province [29] 0 0
Kiev

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

Ethics approval
Ethics application status

Summary
Brief summary
This Phase 3, international, multicenter, open-label study will monitor the long-term safety
of ambrisentan in adults with pulmonary hypertension. The available ambrisentan doses for
this study are 5 or 10 mg administered orally once daily; the approved doses of ambrisentan
in the United States, Canada, and the European Union are 5 and 10 mg. Investigators will be
able to adjust ambrisentan dose as clinically indicated. A minimum of 4 weeks between dose
adjustments is required. Participants receiving other therapies for pulmonary hypertension
that are not contraindicated for concomitant use with ambrisentan are permitted to enroll in
this study and continue to receive such therapies. Participants enrolled in this study will
receive treatment with ambrisentan until such time as the investigator or participant chooses
to stop ambrisentan treatment, ambrisentan becomes commercially available, or the Sponsor
stops the study.
Trial website
https://clinicaltrials.gov/show/NCT00777920
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
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
Other publications