Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1) (ATHENA-1)

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Ambrisentan Only	Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i)
Placebo/Ambrisentan	Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i
Placebo Only	Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i
Total	Total of all reporting groups

Baseline Measures

	Ambrisentan Only	Placebo/Ambrisentan	Placebo Only	Total
Overall Participants Analyzed  [Units: Participants]	33	4	1	38
Age  [Units: Participants]
<=18 years	0	0	0	0
Between 18 and 65 years	29	4	1	34
>=65 years	4	0	0	4
Age  [Units: Years] Mean (Standard Deviation)	48.2  (13.72)	43.5  (14.89)	49.0  (0)	47.8  (13.52)
Gender  [Units: Participants]
Female	26	2	0	28
Male	7	2	1	10
Ethnicity (NIH/OMB)  [Units: Participants]
Hispanic or Latino	8	0	0	8
Not Hispanic or Latino	25	4	1	30
Unknown or Not Reported	0	0	0	0
Race/Ethnicity, Customized  [Units: Participants]
Asian	2	0	0	2
Black or African American	2	0	0	2
Hispanic	1	0	0	1
More than one race	1	0	0	1
White	27	4	1	32
Region of Enrollment  [Units: Participants]
United States	33	4	1	38

1.  Primary:

Change From Baseline in Pulmonary Vascular Resistance (PVR), Last Observation Carried Forward (LOCF)   [ Time Frame: Baseline to Week 24 ]

2.  Secondary:

Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) (LOCF)   [ Time Frame: Baseline to Week 24 ]

3.  Secondary:

Change From Baseline in Mean Right Atrial Pressure (mRAP) (LOCF)   [ Time Frame: Baseline to Week 24 ]

4.  Secondary:

Change From Baseline in Cardiac Output (LOCF)   [ Time Frame: Baseline to Week 24 ]

5.  Secondary:

Change From Baseline in Six Minute Walk Distance (6MWD) Measured at Weeks 4, 12, 24, 36 and 48 (LOCF)   [ Time Frame: Baseline to Week 48 ]

6.  Secondary:

Change in Dyspnea Index Measured at Weeks 4, 12, 24, 36 and 48 (LOCF)   [ Time Frame: Baseline to Week 48 ]

7.  Secondary:

Change From Baseline in the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Quality of Life (QOL) Survey Overall Score Measured at Weeks 12, 24, 36 and 48 (LOCF)   [ Time Frame: Baseline to Week 48 ]

8.  Secondary:

Change From Baseline in World Health Organization (WHO) Functional Class (LOCF) Measured at Weeks 4, 12, 24, 36 and 48.   [ Time Frame: Baseline to Week 48 ]

9.  Secondary:

Change From Baseline in Log-transformed N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Measured at Weeks 4, 12, 24, 36 and 48 (LOCF)   [ Time Frame: Baseline to Week 48 ]

10.  Secondary:

Time to Clinical Worsening of PAH, Evaluated at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and After Week 48   [ Time Frame: Baseline to Week 48+ ]

11.  Secondary:

Overall Survival, Evaluated at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and After Week 48   [ Time Frame: Baseline to Week 48+ ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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