A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00578786
• Date of registration: 19/12/2007
• Prospective Registration: No
• Primary sponsor: Gilead Sciences
• Public title: A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202)
• Scientific title: A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202)
• Date of first enrolment: February 2004
• Target sample size: 383
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00578786
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Argentina, Brazil, Chile, Mexico

Contacts

• Name: Chris Dufton, PhD
• Affiliation: Gilead Sciences

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subject must have completed Week 12 of AMB-320 (NCT00423748) or AMB-321 (NCT00423202)
or must have received placebo during AMB-320 (NCT00423748) or AMB-321 (NCT00423202)
and met two or more early escape criteria;

2. Subject must be competent to understand the information given in the Institutional
Review Board (IRB) or Independent Ethics Committee (IEC) approved informed consent
form and must sign the form prior to the initiation of any study procedures.

3. Female subject of childbearing potential must agree to use two reliable methods of
contraception until study completion and for at least four weeks following their final
study visit. Reliable methods include: birth control pills/implants/injections,
intrauterine devices (IUDs), spermicide, diaphragms, or condoms.

Exclusion Criteria:

- Subjects must have met the exclusion criteria of the AMB-320 (NCT00423748) and AMB-321
(NCT00423202)studies. In addition, a subject who meets any one of the following
criteria is ineligible for participation in the study:

1. Subject receiving bosentan, sildenafil, or iv inotropes at any time within four
weeks prior to the AMB-320/321-E Screening/Randomization Visit;

2. Subject receiving chronic prostanoid therapy (epoprostenol, treprostinil,
iloprost, beraprost, or any other investigational prostacyclin derivative) within
four weeks prior to the AMB-320/321-E Screening/RandomizationVisit;

3. Female subject who is pregnant or breastfeeding;

4. Subject with cardiovascular, liver, renal, hematologic, gastrointestinal,
immunologic, endocrine, metabolic, or central nervous system disease that, in the
opinion of the Investigator, may adversely affect the safety of the subject
and/or efficacy of the study drug or severely limit the lifespan of the subject;

5. Subject who has demonstrated noncompliance with previous medical regimens;

6. Subject who has a recent history of abusing alcohol or illicit drugs;

7. Subject who has participated in a clinical study involving another
investigational drug or device at any time within four weeks prior to the
AMB-320/321-E Screening/Randomization Visit.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: ambrisentan

Primary Outcome(s)

Serum Aminotransferases Relative to the Upper Limit of the Normal Range (ULN) [Time Frame: Baseline to Week 295]

Frequently Reported (15% or More Overall) Adverse Events by Severity [Time Frame: Baseline to Week 295]

Secondary Outcome(s)

Change From Baseline to Year 3 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test [Time Frame: Baseline to Year 3]

Baseline Borg Dyspnea Index [Time Frame: Baseline]

Baseline World Health Organization (WHO) Functional Class [Time Frame: Baseline]

Change From Baseline to Year 2 in World Health Organization (WHO) Functional Class [Time Frame: Baseline to Year 2]

Change From Baseline to Week 24 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test [Time Frame: Baseline to Week 24]

Change From Baseline to Year 1 in World Health Organization (WHO) Functional Class [Time Frame: Baseline to Year 1]

Percentage of Participants With Failure-Free Treatment Status [Time Frame: Baseline to Year 4]

Change From Baseline to Week 48 (Year 1) in Exercise Capacity as Measured by the 6-Minute Walk Distance Test [Time Frame: Baseline to Week 48]

Change From Baseline to Year 3 in World Health Organization (WHO) Functional Class [Time Frame: Baseline to Year 3]

Long-term Survival [Time Frame: Baseline to Year 4]

Change From Baseline to Year 3 in Borg Dyspnea Index [Time Frame: Baseline to Year 3]

Baseline Exercise Capacity as Measured by the 6-Minute Walk Distance Test [Time Frame: Baseline]

Baseline SF-36 Health Survey Scales for the Combined Ambrisentan Group [Time Frame: Baseline]

Change From Baseline to Week 12 in SF-36 Health Survey Scales for the Combined Ambrisentan Group [Time Frame: Baseline to Week 12]

Change From Baseline to Week 24 in SF-36 Health Survey Scales for the Combined Ambrisentan Group [Time Frame: Baseline to Week 24]

Change From Baseline to Year 2 in Borg Dyspnea Index [Time Frame: Baseline to Year 2]

Change From Baseline to Year 2 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test [Time Frame: Baseline to Year 2]

Change From Baseline to Week 36 in SF-36 Health Survey Scales for the Combined Ambrisentan Group [Time Frame: Baseline to Week 36]

Change From Baseline to Year 1 in Borg Dyspnea Index [Time Frame: Baseline to Year 1]

Percentage of Participants With No Clinical Worsening of PAH [Time Frame: Baseline to Year 3]

Secondary ID(s)

AMB-320/321-E

ARIES-E

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/01/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00578786