Trial Outcomes & Findings for Bosentan and Pulmonary Endothelial Function (NCT NCT01721564)

NCT ID: NCT01721564

Last Updated: 2016-10-19

Results Overview

Percent pulmonary flow change from baseline after acetylcholine

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 8 participants
• Primary outcome timeframe: Baseline and 6 months
• Results posted on: 2016-10-19

Participant Flow

Participant milestones

Measure	Bosentan 62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bosentan and Pulmonary Endothelial Function

Baseline characteristics by cohort

Measure	Bosentan n=8 Participants 62.5 mg Bosentan b.i.d. for 1 month 125 mg Bosentan b.i.d. for 5 months
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	66 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment Australia	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Percent pulmonary flow change from baseline after acetylcholine

Outcome measures

Measure	Bosentan n=8 Participants 62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
Acetylcholine Vascular Reactivity Response	180 percentage of baseline Standard Deviation 20

SECONDARY outcome

Timeframe: baseline and 6 months

Change in intima-media thickness

Outcome measures

Measure	Bosentan n=8 Participants 62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
Intravascular Ultrasound - Pulmonary Artery Wall Thickness	34 percentage of baseline Standard Deviation 2

Adverse Events

Bosentan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof David Celermajer

Royal Prince Alfred Hospital, Sydney, Australia

Phone: +61 2 9515 6519

Email: david.celermajer@email.cs.nsw.gov.au

Results disclosure agreements

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