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Study of Ambrisentan in Participants With Pulmonary Hypertension (ABS-LT)

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00777920
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : September 30, 2020
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE July 1, 2008
First Posted Date  ICMJE October 22, 2008
Results First Submitted Date  ICMJE September 8, 2020
Results First Posted Date  ICMJE September 30, 2020
Last Update Posted Date September 30, 2020
Actual Study Start Date  ICMJE November 17, 2008
Actual Primary Completion Date September 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2020)
Percentage of Participants With Adverse Events (AEs) Associated With Long-Term Exposure to Ambrisentan [ Time Frame: First dose date of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks) ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2008)
The primary endpoint of this study is the incidence and severity of AEs associated with long-term exposure to ambrisentan in subjects with PH. [ Time Frame: Three years ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2008)
Additional safety endpoints of interest include: • Shift from baseline (low/normal/high) over time in clinical laboratory values • Change from baseline over time in vital signs [ Time Frame: Three years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Ambrisentan in Participants With Pulmonary Hypertension
Official Title  ICMJE ABS-LT: A Phase 3, Long-Term, Open Label, Multicenter Safety Study of Ambrisentan in Subjects With Pulmonary Hypertension
Brief Summary The primary objective of this study is to monitor the long-term safety of ambrisentan in adult participants with pulmonary hypertension. The available ambrisentan doses for this study are 2.5, 5, or 10 mg administered orally once daily. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Hypertension
Intervention  ICMJE Drug: Ambrisentan
Tablet administered orally once daily
Other Names:
  • Letairis®
  • Volibris
Study Arms  ICMJE Experimental: Ambrisentan
Participants will receive ambrisentan 2.5 mg, 5 mg or 10 mg tablet orally once daily until such time as the investigator or participant chooses to stop ambrisentan treatment, ambrisentan becomes commercially available, or the sponsor stops the study.
Intervention: Drug: Ambrisentan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 16, 2018)
140
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2008)
300
Actual Study Completion Date  ICMJE September 11, 2019
Actual Primary Completion Date September 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Men and women with pulmonary hypertension who are discontinuing a clinical study of ambrisentan due to study closure by the sponsor. Eligible participants are those participating in countries where ambrisentan is not yet commercially available. Participants 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.

Key Exclusion Criteria:

  • Participants who have discontinued an ambrisentan clinical study for any other reason than sponsor-initiated study closure are not eligible.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Canada,   Chile,   Mexico,   Russian Federation,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00777920
Other Study ID Numbers  ICMJE GS-US-300-0124
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Gilead Sciences
Original Responsible Party Jen Kersey, Clinical Program Manager, Gilead Sciences
Current Study Sponsor  ICMJE Gilead Sciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP