Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension.

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00423748
• Date of registration: 17/01/2007
• Prospective Registration: No
• Primary sponsor: Gilead Sciences
• Public title: Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension.
• Scientific title: Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects With Pulmonary Arterial Hypertension
• Date of first enrolment: December 2003
• Target sample size: 186
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00423748
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Key inclusion & exclusion criteria

Inclusion Criteria:

- 18 years of age or order

- Current diagnosis of either PPH orPAH secondary to the scleroderma spectrum of
disease, systemic lupus erythematosus, anorexigen use, or HIV infection at the
Screening Visit

- Right heart catheterization, completed prior to Screening Visit must meet
pre-specified hemodynamic criteria

- Female subjects of childbearing potential must have a negative serum pregnancy test
and must agree to use a reliable double barrier method of contraception until study
completion and for at least four weeks following their final study visit

- Male subjects must be informed of the potential risks of testicular tubular atrophy
and infertility associated with taking this study drug and queried regarding his
understanding of the potential risks as described in the Informed Consent Form

Exclusion Criteria:

- PAH due to or associated with congenital heart disease, coronary artery disease, left
heart disease, interstitial lung disease, chronic obstructive pulmonary disease,
veno-occlusive disease, chronic thrombotic and/or embolic disease, or sleep apnea

- Portopulmonary hypertension

- Bosentan within four weeks prior to Screening

- Phosphodiesterase type V inhibitor or chronic prostanoid therapy within four weeks
prior to Screening

- IV inotrope use within two weeks prior to Screening

- ALT or AST lab value that is greater than 1.5 times the upper limit of normal

- Pulmonary function tests not meeting pre-specified criteria

- Contraindication to treatment with an ERA

- History of malignancies other than basal cell carcinoma of the skin or in situ
carcinoma of the cervix within the past five years

- Females who are pregnant or breastfeeding



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

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: ambrisentan

Primary Outcome(s)

Change from baseline in the six-minute walk distance evaluated after 12 weeks of therapy compared to placebo.

Secondary Outcome(s)

Change from baseline measured after 12 weeks of treatment compared to placebo in the Borg Dyspnea Index; WHO Functional Classification; and the SF-36 Health Survey.

Assessment of the safety and tolerability of the study drug.

Clinical worsening of PAH.

Secondary ID(s)

ARIES-1

AMB-320

Source(s) of Monetary Support

Please refer to primary and secondary sponsors