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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00091598

Enrollment

372

Registered

2004-09-14

Start date

2004-01-31

Completion date

2006-02-28

Last updated

2010-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Keywords

Pulmonary Arterial Hypertension

Brief summary

The primary objective is to determine the effect of ambrisentan on exercise capacity in subjects with PAH.

Detailed description

ARIES-1 in North America and Australia ARIES-2 in Western and Eastern Europe, South America and Israel Subjects in these randomized studies will receive one of two doses of ambrisentan or placebo. Inclusion is not based on a specified WHO functional classification. Rather, subjects with WHO Class I-IV symptoms are eligible if their 6-minute walk distance is 150-450 meters and they meet the study-specified hemodynamic criteria. Subjects with anorexigen or HIV infection related PAH are eligible but subjects with congenital heart disease and pediatric subjects are excluded. The study requires a historical cardiac catheterization and other diagnostic procedures.

Interventions

DRUGAmbrisentan

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline at Week 12 of six minute walk distance	—

Secondary

Measure	Time frame
Change from baseline at Week 12 of:	—
Borg Dsypnea Index	—
WHO Functional Classification	—
SF-36	—
Time to Clinical Worsening	—

Countries

Australia, Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026