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Home > "O" Clinical Trials Conditions > Outcome Study ONTARGET  Outcome Study ONTARGET
Outcome Study ONTARGET
For Condition: Myocardial Infarction,Cerebrovascular Accident,Coronary Disease,Angina Pectoris
Status: Completed
Sponsor(s): Boehringer Ingelheim Pharmaceuticals ,
Synopsis: A large, simple, randomized, double-blind, multicentre, international trial comparing the effects of Telmisartan, Ramipril, and their combination on outcomes in patients at high risk for cardiovascular events.
Details:
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 55 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Male or female subjects, 55 years of age or older, and at high risk of developing a major CVD event are eligible if they have any of the following: Coronary artery disease: - Previous myocardial infarction (> 2 days post uncomplicated MI, prior to informed consent). - Stable angina or unstable angina [(> 30 days prior to informed consent) each with documented multi-vessel coronary disease, > 50% stenosis in at least two major coronary arteries on coronary angiography, or positive stress test (ST depression > 2 mm or a positive nuclear perfusion scintigram)]. - Multi-vessel PTCA > 30 days prior to informed consent. - Multi-vessel CABG surgery > 4 years prior to informed consent, or with recurrent angina following surgery. Peripheral arterial disease: - Previous limb bypass surgery or percutaneous transluminal angioplasty. - Previous limb or foot amputation. - History of intermittent claudication, with an ankle: arm blood pressure ratio < 0.80 on at least one side. - Significant peripheral artery stenosis (> 50%) documented by angiography or non-invasive testing. - Previous Stroke - TIA > 7 days and < 1 year prior to informed consent. - High-risk diabetics (insulin-dependent or non-insulin-dependent) with evidence of end-organ damage: retinopathy, LVH, macro or microalbuminuria, or any evidence of previous cardiac or vascular disease. EXCLUSION CRITERIA: Patients will be excluded if any one of the following criteria is met. Medication use: - Inability to discontinue ACE-inhibitors or AIIA. - Patients with known hypersensitivity or intolerance to AIIA’s or ACE-inhibitors. Cardiovascular disease: - Symptomatic congestive heart failure. - Hemodynamically significant primary valvular or outflow tract obstruction (e.g. aortic or mitral valve stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve). - Constrictive pericarditis. - Complex congenital heart disease. - Syncopal episodes of unknown etiology < 3 months before informed consent. - Planned cardiac surgery or angioplasty within three months. - Uncontrolled hypertension on treatment (i.e. BP > 160/100). - Heart transplant recipient. - Strokes due to subarachnoid hemorrhage. Other conditions: - Significant renal disease defined as: - Renal artery stenosis; - Creatinine clearance < 0.6 ml/min or serum creatinine > 265 mmol/L (> 3.0 mg/dL); - Hyperkalemia: potassium > 5.5 mmol/L. - Hepatic dysfunction as defined by the following laboratory parameters: SGPT (ALT) or SGOT (AST) > than 4 times upper limit of normal or additional criteria for hepatic impairment the upper limit of normal range, total Bilirubin > 20 mmol/L, biliary obstructive disorders. - Uncorrected volume depletion or sodium depletion. - Primary aldosteronism. - Hereditary fructose intolerance. - Any other major non-cardiac illness expected to reduce life expectancy or interfere with study participation. - Patient is simultaneously taking another experimental drug. - Patient with significant disability that precludes regular attendance at clinic for follow-up. - Patient has sufficient disability or other incapacity that precludes regular attendance at clinic for follow-up. - Unable or unwilling to provide written informed consent.
Total Enrollment:
Location and Contact Information:
Olive View Education and Research Center
Sylmar, California, 91342
United States
University of CT Healthcare Center
Farmington, Connecticut, 06030-3940
United States
Howard University Hospital
Washington D.C., District of Columbia, 20060
United States
Cardiology-Internal Medicine Associates, S.C.
Oak Lawn, Illinois, 60453
United States
Medical Research Institute
Tampa, Florida, 33607
United States
Clincial Research Institute of Northern VA
Springfield, Virginia, 22151
United States
Affiliates in Medical Specialties, Medical Groups
West Hills, California, 91307
United States
Iowa Heart Center
Des Moines, Iowa, 50314
United States
Treasure Coast Infectious Disease Consultants (TCIDC)
Vero Beach, Florida, 32960
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Idaho State University
Pocatello, Idaho, 83209-8357
United States
Bronx Nephrology Hypertension PC
Bronx, New York, 10467
United States
Cardiac Centers of Louisiana, LLC
Shreveport, Louisiana, 71103-3971
United States
Maricopa Medical Center
Phoenix, Arizona, 85008
United States
VAMC St. Louis
St. Louis, Missouri, 63106
United States
VAMC Phoenix
Phoenix, Arizona, 85012
United States
Baylor College of Medicine: Neurology Dept.
Houston, Texas, 77030
United States
Westchester Cardiology Associates
Scarsdale, New York, 10583
United States
Clinical Cardiology Research Center
Dallas, Texas, 75246
United States
Southern Clinical Research and Management, Inc. (Medical Village)
Augusta, Georgia, 30904
United States
Naval Medical Center San Diego
San Diego, California, 92134
United States
VA New York Harbor Healthcare System
New York City, New York, 10010
United States
Research Institute of Dallas
Dallas, Texas, 75231
United States
Regions Hospital Cardiology Research
St. Paul, Minnesota, 55101
United States
Medicine II Clinic - E.A. Conway Hospital
Monroe, Louisiana, 71201
United States
Plaza Medical Group
Oklahoma City, Oklahoma, 73112
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294-2041
United States
VAMC Northport Medical Services (111)
Northport, New York, 11768
United States
University of Oklahoma College of Medicine - Tulsa
Tulsa, Oklahoma, 74129
United States
Cleveland Clinic Florida
Weston, Florida, 33331
United States
Frood Eelani, DO - Internal Medicine
Ft. Worth, Texas, 76104
United States
VAMC Las Vegas
Las Vegas, Nevada, 89106
United States
The Lindner Research Center
Cincinnati, Ohio, 45219
United States
VAMC Fargo
Fargo, North Dakota, 68102
United States
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, 73104
United States
Athens Internal Medicine
Athens, Alabama, 35611
United States
Ringrose Clinic, Inc.
Guthrie, Oklahoma, 73044
United States
Buxmont Cardiology Associates
Sellersville, Pennsylvania, 18960
United States
Miguel Sosa-Padilla, MD-Private Practice
Rio Piedras, , 00926
Puerto Rico
Wright State University VA Campus
Dayton, Ohio, 45428
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
People's Health Centers
St. Louis, Missouri, 63112
United States
Palm Harbor Medical Associates
Palm Harbor, Florida, 34684
United States
John Muir, Mt. Diablo Health Network: East Bay Clinical Trials
Concord, California, 94520
United States
Tucson VA Medical Center
Tucson, Arizona, 85723
United States
Cardiology & Internal Medicine
Williamsville, New York, 14221
United States
Medical College of Georgia
Augusta, Georgia, 30912
United States
University of South Carolina School of Medicine
Columbia, South Carolina, 29203
United States
Drummond Clinic
Dallas, Texas, 75235
United States
Shands Teaching Hospital @ Univ. of Florida
Gainesville, Florida, 32610
United States
Centro Clinico San Patricio
Las Lomas, , 00921
Puerto Rico
Portland Cardiovascular Institute
Portland, Oregon, 97216
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
University of California Davis Medical Center
Sacramento, California, 95817
United States
North Central Ohio Clinic, Inc.
Mansfield, Ohio, 44903
United States
Saguaro Clinical Research
Tucson, Arizona, 85712
United States
Cardiology Consultants of Philadelphia
Philadelphia, Pennsylvania, 19148
United States
Suburban Heights Medical Center
Chicago, Illinois, 60411-1790
United States
Duke University Medical Center
Durham, North Carolina, 27713
United States
VAMC Kansas City
Kansas City, Missouri, 64128-2295
United States
Dr. Maurer
New York City, New York, 10034
United States
Loma Linda VA Medical Center
Loma Linda, California, 92354
United States
Ellison Clinic
Conyers, Georgia, 30094
United States
Rochester Cardiopulmonary Group
Rochester, New York, 14621
United States
Val-Oak Professional Corporation
Valdosta, Georgia, 31602
United States
Osteopathic Internal Medicine Associates
Erie, Pennsylvania, 16508
United States
Springfield Medical Center
Panama City, Florida, 32401
United States
Creighton University Cardiac Center
Omaha, Nebraska, 68131-2044
United States
Orocovis Medical Center
Orocovis, , 00720
Puerto Rico
Cooper Hospital/UMC Department of Medicine
Camden, New Jersey, 08103
United States
Mid Valley Cardiology
Kingston, New York, 12401
United States
VAMC Houston
Houston, Texas, 77030
United States
VA Gulf Coast Veterans Health Care System
Biloxi, Mississippi, 39531-2410
United States
VAMC Charleston
Charleston, South Carolina, 29401
United States
VA Hospital
Houston, Texas, 77030
United States
Cook County Hospital General Medicine Clinic; Fantis Health Center
Chicago, Illinois, 60612
United States
St. Joseph's Candler Health System
Savannah, Georgia, 31405
United States
Kaleida Health
Buffalo, New York, 14203
United States
VAMC Milwaukee
Milwaukee, Wisconsin, 53295
United States
VAMC Augusta (509/242)
Augusta, Georgia, 30904
United States
Minneapolis VAMC (111C1)
Minneapolis, Minnesota, 55417
United States
Garrett-Gross Clinic Ltd
Bentonville, Arkansas, 72712
United States
University of Washington
Seattle, Washington, 98195
United States
Kaiser Permanente of Georgia
Tucker, Georgia, 30084
United States
Berman Center for Outcomes and Clinical Research
Minneapolis, Minnesota, 55404
United States
Westwood Cardiology Associates
Westwood, New Jersey, 07675
United States
Wake Forest University Baptist Medical Center/School of Medicine
Winston Salem, North Carolina, 27157-1032
United States
Kaiser Permanente
Harbor City, California, 90710
United States
UT-Southwestern Medical Center
Dallas, Texas, 75390-9047
United States
Primary Care Center
Sandersville, Georgia, 31082
United States
SUNY Downstate
Brooklyn, New York, 11203
United States
Colon-Ortiz Clinic
Caguas, , 00726
Puerto Rico
Cardiac Assoc. of Southern CT
Bridgeport, Connecticut, 06606
United States
Model Clinical Research LLC
Baltimore, Maryland, 21204
United States
UMDNJ - New Jersey Medical School
Newark, New Jersey, 07103
United States
Kaiser Permanente
Los Angeles, California, 90027
United States
Schultz Clinic
San Leandro, California, 94578
United States
Phillips Medical Services
Jackson, Mississippi, 39209
United States
Baystate Medical Center
Springfield, Massachusetts, 01199
United States
Great Lakes Medical Research/Westfield Family Physicians
Westfield, New York, 14787
United States
VAMC East Orange
East Orange, New Jersey, 07018-1095
United States
Policlinica Familiar Monaco
Manati, , 00674
Puerto Rico
Mid Delta Family Practice Clinic
Cleveland, Mississippi, 38732
United States
Additional Information:
Study ID Numbers: BI 502.373;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034931
Other Myocardial Infarction Studies:
1. Lupus Cohort--Thrombotic Events and Coronary Artery Disease
2. Myocardial Infarction Triage and Intervention Project (MITI)
3. Effects of Angiotensin-Converting Enzyme Inhibitor (Ramipril) Therapy on Blood Vessel Inflammation
4. Western Collaborative Group Study (WCGS): 25-Year Follow-up of Cardiovascular Disease Morbidity and Mortality
5. Coronary Artery Risk Development in Young Adults (CARDIA)
Related Studies:
Other Myocardial Infarction Clinical Trials
Other Georgia Clinical Trials
Other Tucker Clinical Trials
Outcome Study ONTARGET
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