Not Signed In -
Hypertension |
High Blood Pressure; Hypertension/High Blood Pressure |
Clinical Trial: ARIES - Ambrisentan in Patients with Moderate to Severe Pulmonary Arterial Hypertension (PAH)
This study is currently recruiting patients.
|
Purpose
The primary objective is to determine the effect of ambrisentan on exercise capacity in subjects with PAH.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Pulmonary Hypertension | Drug: Ambrisentan | Phase III |
MedlinePlus related topics: Pulmonary Hypertension
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
Further Study Details:
Expected Total Enrollment: 372
Study start: January 2004
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 above, Genders Eligible for Study: Both
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.
Location and Contact Information
ARIES PAH Hotline 1-877-ARIESPH (877-274-3774)
Arizona
Pulmonary Associates, PA, Phoenix, Arizona, 85006, United States; Recruiting
Ly Yi Fu, MD 602-258-4951
David Baratz, MD, Principal Investigator
David Baratz, MD, Principal Investigator
California
University of California-Davis, Sacramento, California, 95817, United States; Recruiting
Ellen Vlastelin 916-734-3563
Roblee Allen, MD, Principal Investigator
Roblee Allen, MD, Principal Investigator
Los Angeles County Harbor-UCLA Medical Center, Torrance, California, 90502, United States; Recruiting
Joy Beckman 310-222-3560
Ronald Oudiz, MD, Principal Investigator
Ronald Oudiz, MD, Principal Investigator
University of California San Diego Medical Center, San Diego, California, 92037, United States; Recruiting
Katie Kinninger 858-657-7122
Richard Channick, MD, Principal Investigator
Richard Channick, MD, Principal Investigator
University of Southern California, Los Angeles, California, 90089, United States; Recruiting
Wendy Hill 323-442-5483
Shelley Shapiro, MD, Principal Investigator
Shelley Shapiro, MD, Principal Investigator
Colorado
Myogen, Westminster, Colorado, 80021, United States; Recruiting
University of Colorado Health Sciences Center, Denver, Colorado, 80262, United States; Recruiting
Deb McCollister 303-315-1801
David Badesch, MD, Principal Investigator
David Badesch, MD, Principal Investigator
Connecticut
University of Connecticut Health Center, Farmington, Connecticut, 06030, United States; Recruiting
Patricia Keltonic 860-679-3599
Raymond Foley, DO, Principal Investigator
Raymond Foley, DO, Principal Investigator
Florida
Mt. Sinai Medical Center, Miami, Florida, 33140, United States; Recruiting
Grace Silva 305-674-2610
Ignacio Danta 305-674-2716
Hernando Garcia, MD, Principal Investigator
Ignacio Danta 305-674-2716
Hernando Garcia, MD, Principal Investigator
Georgia
Medical College of Georgia, Augusta, Georgia, 30912, United States; Recruiting
Melissa James 706-721-2566
James Gossage, MD, Principal Investigator
James Gossage, MD, Principal Investigator
Emory University Hospital, Atlanta, Georgia, 30322, United States; Recruiting
Margie Wong 404-712-2886
Bethany Lane 404-712-8204
Clinton Lawrence, MD, Principal Investigator
Bethany Lane 404-712-8204
Clinton Lawrence, MD, Principal Investigator
Illinois
Loyola University Medical Center, Chicago, Illinois, 60153, United States; Recruiting
Merribeth Rhoads 708-216-8223
Sangeeta Bhorade, MD, Principal Investigator
Sangeeta Bhorade, MD, Principal Investigator
Iowa
University of Iowa Hospitals and Clinics, Iowa City, Iowa, 52242, United States; Recruiting
Page Scovel 319-384-8005
Jess Mandel, MD, Principal Investigator
Jess Mandel, MD, Principal Investigator
Louisiana
Ochsner Clinic, New Orleans, Louisiana, 70121, United States; Recruiting
Bobette Harris 504-842-1134
Myung H Park, MD, Principal Investigator
Myung H Park, MD, Principal Investigator
Maine
Maine Medical Center, Portland, Maine, 04102, United States; Recruiting
Maggie Bilodeau 207-828-1122
Joel Wirth, MD, Principal Investigator
Joel Wirth, MD, Principal Investigator
Massachusetts
Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States; Recruiting
Disty Pearson 617-355-6508
Michael Landzberg, MD, Principal Investigator
Michael Landzberg, MD, Principal Investigator
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States; Recruiting
Arlene Shiro 617-726-1250
Aaron Waxman, MD, PhD, Principal Investigator
Aaron Waxman, MD, PhD, Principal Investigator
Michigan
University of Michigan Medical Center, Ann Arbor, Michigan, 48109, United States; Not yet recruiting
Susie McDevitt 734-615-3635
Vallerie McLaughlin, MD, Principal Investigator
Vallerie McLaughlin, MD, Principal Investigator
Wayne State University, Detroit, Michigan, 48201, United States; Recruiting
Roze Kadri 313-745-2361
Kamal Mubarak, MD, Principal Investigator
Kamal Mubarak, MD, Principal Investigator
Minnesota
Mayo Clinic, Rochester, Minnesota, 55905, United States; Recruiting
Louise Durst 507-284-1792
Michael McGoon, MD, Principal Investigator
Michael McGoon, MD, Principal Investigator
Missouri
Washington University, St. Louis, Missouri, 63110, United States; Not yet recruiting
Ann Doyle 314-362-6863
Murali Chakinala, MD, Principal Investigator
Murali Chakinala, MD, Principal Investigator
New York
New York Presbyterian Hospital, New York, New York, 10032, United States; Recruiting
Allison Widlitz, PA 212-305-4436
Robyn Barst, MD, Principal Investigator
Robyn Barst, MD, Principal Investigator
Cardiology PC, Syracuse, New York, 13210, United States; Not yet recruiting
Martha Castle 315-470-7409
Raymond Carlson, MD, Principal Investigator
Raymond Carlson, MD, Principal Investigator
Winthrop University Hospital, Mineola, New York, 11501, United States; Not yet recruiting
Mary Bartlett 516-663-4694
Adam Hurewitz, MD, Principal Investigator
Adam Hurewitz, MD, Principal Investigator
Mt. Sinai Medical Center, New York City, New York, 10029, United States; Recruiting
Nakia Mitchell 212-241-3913
Roxana Sulica, MD, Principal Investigator
Roxana Sulica, MD, Principal Investigator
Northshore University/Long Island Jewish Hospital, Manhasset, New York, 11030, United States; Recruiting
Evelyn Figueredo 516-562-3755
Arunabh Talwar, MD, Principal Investigator
Arunabh Talwar, MD, Principal Investigator
Ohio
University Hospitals of Cleveland, Cleveland, Ohio, 44106, United States; Recruiting
David Haney 216-844-3681
Robert Schilz, DO, Principal Investigator
Robert Schilz, DO, Principal Investigator
Lindner Clinical Trial Center, Cincinnati, Ohio, 45219, United States; Recruiting
Ersela McGary 513-585-1930
Peter Engel, MD, Principal Investigator
Peter Engel, MD, Principal Investigator
Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States; Recruiting
Constance Jennings, MD, Principal Investigator
Oregon
Oregon Health Sciences University, Portland, Oregon, 97202, United States; Recruiting
Lynn Oveson 503-494-7680
Jeffrey Edelman, MD, Principal Investigator
Jeffrey Edelman, MD, Principal Investigator
Pennsylvania
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15213, United States; Recruiting
Carrie Melegari 412-647-7045
Srinivas Murali, MD, Principal Investigator
Srinivas Murali, MD, Principal Investigator
University of Pennsylvania Hospital, Philadelphia, Pennsylvania, 19104, United States; Not yet recruiting
Sandra Kaplan 215-662-9720
Darren Taichman, MD, PhD, Principal Investigator
Darren Taichman, MD, PhD, Principal Investigator
Rhode Island
Rhode Island Hospital, Providence, Rhode Island, 02903, United States; Recruiting
Barbara Smithson 401-444-9097
James Klinger, MD, Principal Investigator
James Klinger, MD, Principal Investigator
Tennessee
Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States; Recruiting
Wendi Lloyd 615-343-8277
Ivan Robbins, MD, Principal Investigator
Ivan Robbins, MD, Principal Investigator
Texas
Baylor College of Medicine, Houston, Texas, 77030, United States; Recruiting
Helena Purl 713-394-6130
Adaani Frost, MD, Principal Investigator
Adaani Frost, MD, Principal Investigator
St. Paul Hospital, Dallas, Texas, 75235, United States; Recruiting
Martha Kingman 214-879-3415
Fernando Torres, MD, Principal Investigator
Fernando Torres, MD, Principal Investigator
Virginia
Virginia Commonwealth University, Richmond, Virginia, 23298, United States; Recruiting
Janet Pinson 804-828-9071
Paul Fairman, MD, Principal Investigator
Paul Fairman, MD, Principal Investigator
University of Virginia Health System, Charlottesville, Virginia, 22908, United States; Recruiting
Steve Patterson 434-982-0054
Mark Robbins, MD, Principal Investigator
Mark Robbins, MD, Principal Investigator
Wisconsin
Heart Care Associates, Milwaukee, Wisconsin, 53215, United States; Recruiting
Don Lobacz 414-649-3438
Dianne Zwicke, MD, Principal Investigator
Dianne Zwicke, MD, Principal Investigator
Canada, Quebec
Jewish General Hospital, Montreal, Quebec, H3T1E2, Canada; Recruiting
Lyda Lesenko 514-340-8222
David Langleben, MD, Principal Investigator
David Langleben, MD, Principal Investigator
Study chairs or principal investigators
Lewis J. Rubin, MD, Study Chair, University of California San Diego, San Diego School of Medicine
More Information
Pulmonary Hypertension Association
Study ID Numbers: ARIES
Record last reviewed: October 2004
Last Updated: October 13, 2004
Record first received: September 10, 2004
ClinicalTrials.gov Identifier: NCT00091598
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: October 2004
Last Updated: October 13, 2004
Record first received: September 10, 2004
ClinicalTrials.gov Identifier: NCT00091598
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
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