ARIES - Ambrisentan in Patients With Moderate to Severe Pulmonary Arterial Hypertension (PAH)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00091598
• Date of registration: 10/09/2004
• Prospective Registration: No
• Primary sponsor: Gilead Sciences
• Public title: ARIES - Ambrisentan in Patients With Moderate to Severe Pulmonary Arterial Hypertension (PAH)
• Scientific title: ARIES 1 and ARIES 2: 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: January 2004
• Target sample size: 372
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00091598
• 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

Countries of recruitment

Australia, Canada, United States

Contacts

• Name: Lewis J. Rubin, MD
• Affiliation: University of California San Diego, San Diego School of Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of idiopathic PAH (formally known as PPH), or PAH associated with collagen
vascular disease, anorexigen use, or HIV infection;

- Historical cardiac catheterization with the following hemodynamic criteria:

Mean pulmonary artery pressure greater than or equal to 25 mmHg; Pulmonary vascular
resistance greater than 3 mmHg/L/min; Pulmonary capillary wedge pressure or left
ventricular end diastolic pressure less than 15 mmHg;

- 6-minute walk distance of at least 150 meters, but no more than 450 meters;

- Total lung capacity greater than or equal to 70% and FEV1 greater than or equal to
65% of predicted normal;

Exclusion Criteria:

- Portopulmonary hypertension;

- Subjects with PAH due to or associated with coronary artery disease, left heart
disease, interstitial lung disease, chronic obstructive pulmonary disease,
veno-occlusive disease, chronic thromboembolic disease, or sleep apnea;

- Bosentan (Tracleer®), sildenafil (Viagra®), or chronic prostanoid therapy within 4
weeks of screening;

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

- Contraindication to treatment with an endothelin receptor antagonist;

- Subject with cardiovascular, hepatic, renal, hematologic, gastrointestinal,
immunologic, endocrine, metabolic, or central nervous system disease that may
adversely affect the safety of the subject;

- Participation in a clinical study involving another investigational drug within 4
weeks of screening.



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

Health Condition(s) or Problem(s) studied

Pulmonary Hypertension

Intervention(s)

Drug: Ambrisentan

Primary Outcome(s)

Change from baseline at Week 12 of six minute walk distance

Secondary Outcome(s)

Change from baseline at Week 12 of:

Time to Clinical Worsening

WHO Functional Classification

Borg Dsypnea Index

SF-36

Secondary ID(s)

ARIES

Source(s) of Monetary Support

Please refer to primary and secondary sponsors