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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 10, 2004

Last Updated Date

January 17, 2007

Start Date ^†

January 2004

Current Primary Outcome Measures ^†

Change from baseline at Week 12 of six minute walk distance

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00091598 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Pulmonary Hypertension

Intervention ^†

Drug: Ambrisentan

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

372

Completion Date

February 2006

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Australia, Canada

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00091598

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Gilead Sciences

Collaborators ^††

Investigators ^†

Study Chair:

Lewis J. Rubin, MD

University of California San Diego, San Diego School of Medicine

Information Provided By

Gilead Sciences

Verification Date

July 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.