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

This study has been completed.
Sponsor:
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00091598
First received: September 10, 2004
Last updated: March 4, 2010
Last verified: March 2010
  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 3

Gilead Sciences has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:


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
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
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:
No publications provided by Gilead Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00091598     History of Changes
Other Study ID Numbers: ARIES
Study First Received: September 10, 2004
Last Updated: March 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Pulmonary Arterial Hypertension

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014