Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension

This study has been completed.

Study NCT00380068 Information provided by Gilead Sciences

First Received on September 21, 2006. Last Updated on December 8, 2010 History of Changes

Results First Received: July 10, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Pulmonary Hypertension
Intervention:	Drug: Ambrisentan

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted between December 2006 and December 2007 in 42 centers in the United States, Australia and Canada

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The screening period was 4 weeks. Patients who received bosentan or sitaxsentan within 4 weeks prior to the screening visit were excluded.

Reporting Groups

	Description
Ambrisentan 5 mg PO Once a Day	No text entered.

Participant Flow: Overall Study

	Ambrisentan 5 mg PO Once a Day
STARTED	224
COMPLETED	190
NOT COMPLETED	34
Adverse Event	17
Death	6
Withdrawal by Subject	5
noncompliance	2
subject moved	1
pre-planned lung transplant	1
Lost to Follow-up	1
Addition of other PAH therapeutic agent	1

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Ambrisentan 5 mg PO Once a Day	No text entered.

Baseline Measures

	Ambrisentan 5 mg PO Once a Day
Number of Participants [units: participants]	224
Age [units: years] Mean ± Standard Deviation	55 ± 16
Gender [units: participants]
Female	156
Male	68

Outcome Measures

Show All Outcome Measures

1. Primary:

Change From Baseline to Week 24 in 6 Minute Walk Distance (6MWD) [ Time Frame: Baseline to Week 24 ]

Show Outcome Measure 1

2. Secondary:

Percent of Participants With no Clinical Worsening of Pulmonary Hypertension at Week 24. [ Time Frame: 24 weeks ]

Show Outcome Measure 2

3. Secondary:

Change From Baseline to Week 24 in WHO Functional Class [ Time Frame: Baseline to Week 24 ]

Show Outcome Measure 3

4. Secondary:

Percent Change From Baseline to Week 24 in B-type Natriuretic Peptide (BNP) [ Time Frame: Baseline to Week 24 ]

Show Outcome Measure 4

5. Secondary:

Long-term Survival [ Time Frame: Week 24 ]

Show Outcome Measure 5

6. Secondary:

Change From Baseline to Week 24 in Borg Dyspnea Index [ Time Frame: Baseline to Week 24 ]

Show Outcome Measure 6

7. Secondary:

Change From Baseline to Week 24 in SF-36 Health Survey Physical Functioning Scale [ Time Frame: Baseline to Week 24 ]

Show Outcome Measure 7

8. Secondary:

Monotherapy Treatment Status [ Time Frame: Week 24 ]

Show Outcome Measure 8

9. Secondary:

Failure-free Treatment Status [ Time Frame: Week 24 ]

Show Outcome Measure 9

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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: PIs have right disclose data upon publication of a multi-center publication coordinated by Sponsor or 18 months after Study is completed at all sites if multi-center publication is not submitted by Sponsor within 12 mos. PI to furnish Sponsor with copy of proposed disclosure at least 90 days prior to proposed disclosure. Sponsor has right to ensure accuracy of disclosure and request deletion of CI however may not make editorial changes to the results or conclusions.

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: Martine Allard, PhD; Senior Clinical Research Scientist
Organization: Gilead Sciences Inc
phone: 650-524-3898
e-mail: martine.allard@gilead.com

No publications provided

Responsible Party:	Martine Allard, PhD, Gilead Sciences, Inc.
ClinicalTrials.gov Identifier:	NCT00380068 History of Changes
Other Study ID Numbers:	AMB-323, ARIES-3
Study First Received:	September 21, 2006
Results First Received:	July 10, 2009
Last Updated:	December 8, 2010
Health Authority:	United States: Food and Drug Administration