Trial Outcomes & Findings for Ambrisentan in Patients With Porto-pulmonary Hypertension A Multicenter Open Label Trial (NCT NCT01224210)

NCT ID: NCT01224210

Last Updated: 2021-01-12

Results Overview

Change in Pulmonary Vascular Resistance from baseline to Week 24 for all patients (using cardiac output \[CO\] measured by the thermodilution method and reported as percent difference from baseline).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 30 participants
• Primary outcome timeframe: from baseline to Week 24
• Results posted on: 2021-01-12

Participant Flow

Participant milestones

Measure	Ambrisentan (24 Weeks), Extension (4 Weeks) Treatment-naive Group 1 Pulmonary Arterial Hypertension patients with Porto-pulmonary Hypertension with Child-Pugh class A/B were administered with ambrisentan for 24 weeks, followed by a long-term extension (24-28 weeks).
Overall Study STARTED	30
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Ambrisentan (24 Weeks), Extension (4 Weeks) n=30 Participants Long-term extension of 24-28 weeks of ambrisentan.
Age, Categorical <=18 years	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=30 Participants
Age, Categorical >=65 years	0 Participants n=30 Participants
Age, Continuous	50 years STANDARD_DEVIATION 5 • n=30 Participants
Sex: Female, Male Female	18 Participants n=30 Participants
Sex: Female, Male Male	12 Participants n=30 Participants
Region of Enrollment United States	19 participants n=30 Participants
pulmonary vascular resistance	7.1 HRU/Wood units STANDARD_DEVIATION 5 • n=30 Participants

PRIMARY outcome

Timeframe: from baseline to Week 24

Change in Pulmonary Vascular Resistance from baseline to Week 24 for all patients (using cardiac output [CO] measured by the thermodilution method and reported as percent difference from baseline).

Outcome measures

Measure

Ambrisentan n=30 Participants Open Label Ambrisentan Ambrisentan: Ambrisentan once-daily in the morning with or without food. The adult dose selected for this study will be 5 mg for the first 4 weeks. After the initial 4 weeks the dose will be increased to 10mg (available doses are 5, and 10 mg) based on tolerance safety. Subjects will remain on 10mg until they complete the study. Dose adjustments may be made based on side effects.

Change in Pulmonary Vascular Resistance

7.1 percent difference from baseline Standard Deviation 5

PRIMARY outcome

Timeframe: Change from baseline to Week 24

Change from baseline in 6 Minute Walk Distance to Week 24 for all patients. (difference measured in meters).

Outcome measures

Measure	Ambrisentan n=30 Participants Open Label Ambrisentan Ambrisentan: Ambrisentan once-daily in the morning with or without food. The adult dose selected for this study will be 5 mg for the first 4 weeks. After the initial 4 weeks the dose will be increased to 10mg (available doses are 5, and 10 mg) based on tolerance safety. Subjects will remain on 10mg until they complete the study. Dose adjustments may be made based on side effects.
6 Minute Walk Distance Baseline	314 meters Standard Deviation 94
6 Minute Walk Distance Week 24	336 meters Standard Deviation 108

Adverse Events

Ambrisentan (24 Weeks), Extension (4 Weeks)

Serious events: 14 serious events

Other events: 1 other events

Deaths: 4 deaths

Serious adverse events

Measure	Ambrisentan (24 Weeks), Extension (4 Weeks) n=30 participants at risk Treatment-naive Group 1 Pulmonary Arterial Hypertension patients with Porto-pulmonary Hypertension with Child-Pugh class A/B were administered with ambrisentan for 24 weeks, followed by a long-term extension (24-28 weeks).
Respiratory, thoracic and mediastinal disorders Edema	36.7% 11/30 • Number of events 11
Musculoskeletal and connective tissue disorders Headache	10.0% 3/30 • Number of events 3

Other adverse events

Measure	Ambrisentan (24 Weeks), Extension (4 Weeks) n=30 participants at risk Treatment-naive Group 1 Pulmonary Arterial Hypertension patients with Porto-pulmonary Hypertension with Child-Pugh class A/B were administered with ambrisentan for 24 weeks, followed by a long-term extension (24-28 weeks).
Blood and lymphatic system disorders Leg Edema	3.3% 1/30 • Number of events 1

Additional Information

Ioana Preston MD

Tufts Medical Center

Phone: 617-636-7609

Email: ipreston@tuftsmedicalcenter.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place