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

Sponsored by:	Gilead Sciences
Information provided by:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00091598

Purpose

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

Condition	Intervention	Phase
Pulmonary Hypertension	Drug: Ambrisentan	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official 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

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Ambrisentan

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

Change from baseline at Week 12 of six minute walk distance

Secondary Outcome Measures:

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

Estimated Enrollment:	372
Study Start Date:	January 2004
Estimated Study Completion Date:	February 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091598

Show 46 Study Locations

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Chair:

Lewis J. Rubin, MD

University of California San Diego, San Diego School of Medicine

More Information

Additional Information:

Pulmonary Hypertension Association This link exits the ClinicalTrials.gov site

No publications provided by Gilead Sciences

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Galiè N, Olschewski H, Oudiz RJ, Torres F, Frost A, Ghofrani HA, Badesch DB, McGoon MD, McLaughlin VV, Roecker EB, Gerber MJ, Dufton C, Wiens BL, Rubin LJ; Ambrisentan in Pulmonary Arterial Hypertension, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Studies (ARIES) Group. Ambrisentan for the treatment of pulmonary arterial hypertension: results of the ambrisentan in pulmonary arterial hypertension, randomized, double-blind, placebo-controlled, multicenter, efficacy (ARIES) study 1 and 2. Circulation. 2008 Jun 10;117(23):3010-9. Epub 2008 May 27.

Study ID Numbers:	ARIES
Study First Received:	September 10, 2004
Last Updated:	January 17, 2007
ClinicalTrials.gov Identifier:	NCT00091598 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Gilead Sciences:

Pulmonary Arterial Hypertension

Study placed in the following topic categories:

Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Idiopathic Pulmonary Hypertension
Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on September 03, 2009