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

• Sponsor: Gilead Sciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00091598
• Collaborator: (none)
• Enrollment: 372
• Locations: 46
• Duration (Months): 25
• Patients Per Site: 8.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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

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 Design

• Study Type: Interventional
• 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: Jan 1, 2004
• Actual Primary Completion Date: Feb 1, 2006
• Actual Study Completion Date: Feb 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Pulmonary Associates, PA	Phoenix	Arizona	United States	85006
2	Arizona Pulmonary Specialists	Phoenix	Arizona	United States	85013
3	Brentwood Biomedical Research Institute	Los Angeles	California	United States	90073
4	University of California-Davis	Sacramento	California	United States	95817
5	University of California San Diego Medical Center	San Diego	California	United States	92037
6	Los Angeles County Harbor-UCLA Medical Center	Torrance	California	United States	90502
7	University of Colorado Health Sciences Center	Denver	Colorado	United States	80262
8	Myogen	Westminster	Colorado	United States	80021
9	University of Connecticut Health Center	Farmington	Connecticut	United States	06030
10	Mt. Sinai Medical Center	Miami	Florida	United States	33140
11	Emory University Hospital	Atlanta	Georgia	United States	30322
12	Medical College of Georgia	Augusta	Georgia	United States	30912
13	Loyola University Medical Center	Chicago	Illinois	United States	60153
14	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
15	Ochsner Clinic	New Orleans	Louisiana	United States	70121
16	Maine Medical Center	Portland	Maine	United States	04102
17	Johns Hopkins University	Baltimore	Maryland	United States	21205
18	Tufts New England Medical Center	Boston	Massachusetts	United States	02111
19	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
20	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
21	University of Michigan Medical Center	Ann Arbor	Michigan	United States	48109
22	Wayne State University	Detroit	Michigan	United States	48201
23	Mayo Clinic	Rochester	Minnesota	United States	55905
24	Washington University	St. Louis	Missouri	United States	63110
25	Northshore University/Long Island Jewish Hospital	Manhasset	New York	United States	11030
26	Winthrop University Hospital	Mineola	New York	United States	11501
27	Mt. Sinai Medical Center	New York City	New York	United States	10029
28	New York Presbyterian Hospital	New York	New York	United States	10032
29	Cardiology PC	Syracuse	New York	United States	13210
30	Lindner Clinical Trial Center	Cincinnati	Ohio	United States	45219
31	University Hospitals of Cleveland	Cleveland	Ohio	United States	44106
32	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
33	Oregon Health Sciences University	Portland	Oregon	United States	97202
34	University of Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19104
35	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
36	Rhode Island Hospital	Providence	Rhode Island	United States	02903
37	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
38	St. Paul Hospital	Dallas	Texas	United States	75235
39	Baylor College of Medicine	Houston	Texas	United States	77030
40	University of Texas - San Antonio	San Antonio	Texas	United States	78229
41	Scott & White Hospital	Temple	Texas	United States	76508
42	University of Virginia Health System	Charlottesville	Virginia	United States	22908
43	Virginia Commonwealth University	Richmond	Virginia	United States	23298
44	Heart Care Associates	Milwaukee	Wisconsin	United States	53215
45	St. Vincent's Hospital	Sydney	New South Wales	Australia	2010
46	Jewish General Hospital	Montreal	Quebec	Canada	H3T1E2

Sponsors and Collaborators

• Gilead Sciences

Investigators

• Study Chair: Lewis J. Rubin, MD, University of California San Diego, San Diego School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Pulmonary Hypertension Association

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00091598
• Other Study ID Numbers: ARIES
• First Posted: Sep 14, 2004
• Last Update Posted: Mar 8, 2010
• Last Verified: Mar 1, 2010

• Keywords provided by , ,: Pulmonary Arterial Hypertension
• Additional relevant MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension; Ambrisentan

Study Results

No Results Posted as of Mar 8, 2010