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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Gilead Sciences

ClinicalTrials.gov Identifier:

NCT00617305

First received: February 6, 2008

Last updated: June 22, 2012

Last verified: June 2012

History of Changes

Results First Received: May 11, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Pulmonary Arterial Hypertension
Interventions:	Drug: Ambrisentan Drug: Placebo Drug: Sildenafil Drug: Tadalafil

Participant Flow

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Baseline Characteristics

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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
Number of Participants [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

Outcome Measures

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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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 ]

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6. Secondary:

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

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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 ]

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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 ]

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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 ]

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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+ ]

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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+ ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
The study has been completed at all study sites for at least 2 years

Limitations and Caveats

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
No text entered.

Results Point of Contact:

Name/Title: Ellen Shen, PhD, Senior Manager, Regulatory Affairs
Organization: Gilead Sciences
phone: +1 (650) 522-5278
e-mail: Ellen.Shen@gilead.com

No publications provided

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00617305 History of Changes
Other Study ID Numbers:	GS-US-300-0117
Study First Received:	February 6, 2008
Results First Received:	May 11, 2012
Last Updated:	June 22, 2012
Health Authority:	United States: Food and Drug Administration

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