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

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ClinicalTrials.gov Identifier: NCT00091598
Recruitment Status : Completed
First Posted : September 14, 2004
Last Update Posted : March 8, 2010
Sponsor:
Information provided by:
Gilead Sciences

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

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: Ambrisentan Phase 3

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

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 Type : Interventional  (Clinical Trial)
Enrollment : 372 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : January 2004
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006





Primary Outcome Measures :
  1. Change from baseline at Week 12 of six minute walk distance

Secondary Outcome Measures :
  1. Change from baseline at Week 12 of:
  2. Borg Dsypnea Index
  3. WHO Functional Classification
  4. SF-36
  5. Time to Clinical Worsening


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00091598     History of Changes
Other Study ID Numbers: ARIES
First Posted: September 14, 2004    Key Record Dates
Last Update Posted: March 8, 2010
Last Verified: March 2010

Keywords provided by Gilead Sciences:
Pulmonary Arterial Hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Ambrisentan
Antihypertensive Agents