Trial Outcomes & Findings for The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study (NCT NCT02253394)

Last Updated: 2019-11-15

Results Overview

Study the effect of combination ambrisentan (5-10 mg/d) + spironolactone (50 mg/d) on pVO2 and cardiac output. The pVO2 refers to a measure of general physical fitness measured during exercise.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

2 participants

Primary outcome timeframe

Up to average of 20 min

Results posted on

2019-11-15

Participant Flow

Participant milestones

Participant milestones
Measure	AMB + Spiro First, Then Placebo, Cardiopulmonary Fitness Ambrisentan 5 or 10 mg every day (QD) plus Spironolactone 50 mg QD FIRST, then placebo	AMB + Placebo First, Then Spironolactone Ambrisentan 5 or 10 mg every day (QD) plus placebo first, then spironolactone 50 mg QD
Overall Study STARTED	0	2
Overall Study COMPLETED	0	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AMB + Spiro, Cardiopulmonary Fitness n=2 Participants Ambrisentan 5 or 10 mg every day (QD) Spironolactone 50 mg QD Ambrisentan plus Spironolactone: Cardiopulmonary fitness Cross over design
Age, Categorical <=18 years	0 Participants n=2 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=2 Participants
Age, Categorical >=65 years	0 Participants n=2 Participants
Age, Continuous	61 years n=2 Participants
Sex: Female, Male Female	2 Participants n=2 Participants
Sex: Female, Male Male	0 Participants n=2 Participants
Region of Enrollment United States	2 Participants n=2 Participants
Study-Specific Measure	2 Participants n=2 Participants

PRIMARY outcome

Timeframe: Up to average of 20 min

Population: Data were not reported due to patient privacy considerations owing to low enrollment.

Study the effect of combination ambrisentan (5-10 mg/d) + spironolactone (50 mg/d) on pVO2 and cardiac output. The pVO2 refers to a measure of general physical fitness measured during exercise.

Outcome measures

Outcome data not reported

Adverse Events

AMB + Spiro, Cardiopulmonary Fitness

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Cardiopulmonary Fitness

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

Dr. Bradley Maron

Brigham and Women's Hospital

Phone: 617-525-4857

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place