EVEREST: Efficacy of Vasopressin Antagonism in hEart failuRE: Outcome Study With Tolvaptan
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00071331
Collaborator
(none)
3,600
378
34
9.5
0.3
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the effectiveness of tolvaptan or placebo in adults with worsening congestive heart failure (CHF).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
Study Design: Multicenter, randomized, double-blind, placebo-controlled
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Protocol 156-03-236: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long Term Efficacy and Safety of Oral Tolvaptan Tablets in Subjects Hospitalized With Worsening Congestive Heart Failure
Study Start Date
:
Sep 1, 2003
Actual Primary Completion Date
:
Jul 1, 2006
Actual Study Completion Date
:
Jul 1, 2006
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age greater than or equal to 18 years.
-
Current hospitalization for chronic congestive heart failure with admission up to 48 hours prior to randomization. Chronic heart failure is defined as requiring treatment for a minimum of 30 days prior to hospitalization.
The subject must have signs of extracellular volume expansion, defined as two or more of the following: a) jugular venous distention; b) pitting edema (>1+); or c) dyspnea.
-
NYHA Class III or IV at the time of hospitalization.
-
Left Ventricular Ejection Fraction < = 40% within one year.
Exclusion Criteria
-
Women who will not adhere to the reproductive precautions as outlined in the Informed Consent form.
-
Positive urine pregnancy test.
-
Inability to provide written informed consent.
-
Cardiac surgery within 60 days of potential study enrollment, excluding percutaneous coronary interventions.
-
Planned revascularization procedures, electrophysiologic (EP) device implantation, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study enrollment.
-
Subjects who are on cardiac mechanical support.
-
History of bi-ventricular pacer placement within the last 60 days.
-
Co-morbid condition with an expected survival less than six months.
-
Subjects with acute ST segment elevation myocardial infarction at the time of hospitalization.
-
History of sustained ventricular tachycardia or ventricular fibrillation within 30 days, unless in the presence of an automatic implantable cardioverter defibrillator.
-
History of a cerebrovascular accident within the last 30 days.
-
Hemodynamically significant uncorrected primary cardiac valvular disease.
-
Hypertrophic cardiomyopathy (obstructive or non-obstructive).
-
CHF due to uncorrected thyroid disease, active myocarditis or known amyloid cardiomyopathy.
-
Subjects with progressive or episodic neurological disease such as multiple sclerosis or history of multiple strokes.
-
History of primary significant liver disease or acute hepatic failure, as defined by the investigator.
-
History of poorly controlled diabetes mellitus.
-
Morbid obesity, defined as > 159 kg (or 350 lbs) or BMI > 40.
-
Supine systolic arterial blood pressure < 90 mmHg.
-
Serum creatinine > 3.5 mg/dL or > 309.4 mmol/L.
-
Serum potassium > 5.5 mEq/L or > 5.5 mmol/L.
-
Hemoglobin < 9 g/dL or < 90 g/L.
-
History of hypersensitivity and/or idiosyncratic reaction to benzazepine derivatives (such as benazapril).
-
History of drug or medication abuse within the past year, or current alcohol abuse.
-
Inability to take oral medications.
-
Participation in another clinical drug or device trial within the past 30 days.
-
Previous participation in this or any other tolvaptan clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
| 2 | The Heart Center | Huntsville | Alabama | United States | 35801 |
| 3 | The Heart Group | Mobile | Alabama | United States | 36608 |
| 4 | Phoenix Memorial Hospital | Gilbert | Arizona | United States | 85233 |
| 5 | Arizona Heart Institute | Phoenix | Arizona | United States | 85006 |
| 6 | Saguaro Clinical Research | Tucson | Arizona | United States | 85712 |
| 7 | Central Arkansas Veterans Healthcare Systems | Little Rock | Arkansas | United States | 72205 |
| 8 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 9 | Bakersfield Memorial Hospital | Bakersfield | California | United States | 93301 |
| 10 | Central Cardiology Medical Center | Bakersfield | California | United States | 93301 |
| 11 | Cardiology Associates | Larkspur | California | United States | 94939 |
| 12 | Loma Linda University Medical Center | Loma Linda | California | United States | 92354 |
| 13 | LAC/USC Medical Center | Los Angeles | California | United States | 90033 |
| 14 | VA Medical Center- W. Los Angeles | Los Angeles | California | United States | 90073 |
| 15 | Mission Internal Medical Group | Mission Viejo | California | United States | 92691 |
| 16 | ARI Clinical Trials | Redondo Beach | California | United States | 92077 |
| 17 | San Diego Cardiac Center | San Diego | California | United States | 92123 |
| 18 | Pacific Heart Institute | Santa Monica | California | United States | 90404 |
| 19 | Cardiovascular Consultants Medical Group, Inc. | Walnut Creek | California | United States | 94598 |
| 20 | Aurora Denver Cardiology Associates | Denver | Colorado | United States | 80218 |
| 21 | University of Colorado | Denver | Colorado | United States | 80262 |
| 22 | Heart and Vascular Clinic of North Colorado | Fort Collins | Colorado | United States | 80528 |
| 23 | Bakus Resesarch | Norwich | Connecticut | United States | 06360 |
| 24 | Christiana Care Health System | Newark | Delaware | United States | 19718 |
| 25 | VA Medical Center | Washington | District of Columbia | United States | 20422 |
| 26 | Florida Cardiovascular Research | Atlantis | Florida | United States | 33462 |
| 27 | Cardiology Associates of Fort Lauderdale | Fort Lauderdale | Florida | United States | 33308 |
| 28 | Jacksonville Heart Center | Jacksonville Beach | Florida | United States | 32250 |
| 29 | Jacksonville Heart Center | Jacksonville | Florida | United States | 32207 |
| 30 | Jacksonville Center for Clinical Research | Jacksonville | Florida | United States | 32216 |
| 31 | Melbourne Internal Medicine Assoc. | Melbourne | Florida | United States | 32901 |
| 32 | University of Miami/ Jackson Memorial Hospital | Miami | Florida | United States | 33136 |
| 33 | Miami Research and Education Foundation | Miami | Florida | United States | 33156 |
| 34 | Ocala Resarch Institute | Ocala | Florida | United States | 34480 |
| 35 | Cardiology Research Associates | Ormond Beach | Florida | United States | 32174 |
| 36 | Charlotte Heart Group Research Center | Port Charlotte | Florida | United States | 33952 |
| 37 | Cardiovascular Center of Sarasota | Sarasota | Florida | United States | 34239 |
| 38 | The Heart and Vascular Institute of Florida | St. Petersburg | Florida | United States | 33701 |
| 39 | Cardiac Disease Specialists PC | Atlanta | Georgia | United States | 30309 |
| 40 | Atlanta Heart and Vascular Research Group | Atlanta | Georgia | United States | 30342 |
| 41 | Georgia Heart Specialists | Covington | Georgia | United States | 30014 |
| 42 | Idaho Cardiology Associates | Boise | Idaho | United States | 83704 |
| 43 | Idaho Cardiology Associates | Meridian | Idaho | United States | 83642 |
| 44 | North Shore Cardiologists | Bannockburn | Illinois | United States | 60015 |
| 45 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 46 | Midwest Heart Research Found. | Lombard | Illinois | United States | 60148 |
| 47 | Illinois Heart & Lung Associates | Normal | Illinois | United States | 61761 |
| 48 | Heart Care Midwest | Peoria | Illinois | United States | 61603 |
| 49 | The Care Group | Indianapolis | Indiana | United States | 46260 |
| 50 | Mid America Cardiology | Kansas City | Kansas | United States | 66160 |
| 51 | Cardiovascular Associates | Louisville | Kentucky | United States | 40205 |
| 52 | Louisville Cardiology Medical Group | Louisville | Kentucky | United States | 40207 |
| 53 | The Louisiana Heart Center | Chalmette | Louisiana | United States | 70043 |
| 54 | Northshore Medical Research | Covington | Louisiana | United States | 70433 |
| 55 | Leonard J Chabert Medical Center | Houma | Louisiana | United States | 70360 |
| 56 | Lousiana State University Health Sciences Center | Shreveport | Louisiana | United States | 71103 |
| 57 | Cardiac Centers of LA, LLC | Shreveport | Louisiana | United States | 71135 |
| 58 | Androscoggin Cardiology Associates | Auburn | Maine | United States | 04210 |
| 59 | Northeast Cardiology Associates | Bangor | Maine | United States | 04401 |
| 60 | Maine Medical Center | Portland | Maine | United States | 04102 |
| 61 | MidAtlantic Cardiovascular Associates | Baltimore | Maryland | United States | 21218 |
| 62 | Midatlantic Cardiovascular Associates | Baltimore | Maryland | United States | 21229 |
| 63 | MidAtlantic Cardiovascular Associates | Baltimore | Maryland | United States | 21237 |
| 64 | Midatlantic Cardiovascular Associates | Bel Air | Maryland | United States | 21014 |
| 65 | Shore Health System | Easton | Maryland | United States | 21601 |
| 66 | MidAtlantic Cardiovascular Associates | Towson | Maryland | United States | 21204 |
| 67 | Heart Associates, P.A. | Towson | Maryland | United States | 21286 |
| 68 | MidAtlantic Cardiovascular Associates | Westminster | Maryland | United States | 21157 |
| 69 | Primary Care Cardiology Research | Ayer | Massachusetts | United States | 01432 |
| 70 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 71 | Beth Israel Medical Center | Boston | Massachusetts | United States | 02215 |
| 72 | John Dingell VA Medical Center | Detroit | Michigan | United States | 48201 |
| 73 | Nisus Research | Petoskey | Michigan | United States | 49770 |
| 74 | William Beaumont Hospital | Royal Oak | Michigan | United States | 48073-1026 |
| 75 | Covenant Medical Center | Saginaw | Michigan | United States | 48602 |
| 76 | Beaumont Hospital | Troy | Michigan | United States | 48085 |
| 77 | Michigan Heart | Ypsilanti | Michigan | United States | 48197 |
| 78 | Minneapolis Heart Institute | Minneapolis | Minnesota | United States | 55407 |
| 79 | Hennepin County Medical Center | Minneapolis | Minnesota | United States | 55416 |
| 80 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
| 81 | Mayo Clinic, Division of Cardiology | Rochester | Minnesota | United States | 55905 |
| 82 | Park Nicollet Heart Center | St. Louis Park | Minnesota | United States | 55426 |
| 83 | Regions Hospital Cardiology Research | St. Paul | Minnesota | United States | 55101 |
| 84 | St. Paul Heart Clinic | St. Paul | Minnesota | United States | 55102 |
| 85 | Cardiology Associates of North Mississippi | Tupelo | Mississippi | United States | 38801 |
| 86 | Missouri Cardiovascular Specialists | Columbia | Missouri | United States | 65201 |
| 87 | VA Medical Center- Kansas City | Kansas City | Missouri | United States | 64128 |
| 88 | St. Louis University | St. Louis | Missouri | United States | 63110 |
| 89 | Bryan LGH Heart Institute | Lincoln | Nebraska | United States | 68516 |
| 90 | Heart Consultants | Omaha | Nebraska | United States | 68122 |
| 91 | New England Heart Institute | Manchester | New Hampshire | United States | 03102 |
| 92 | Morristown Memorial Hospital | Morristown | New Jersey | United States | 07962-1956 |
| 93 | University of Medicine and Dentistry of New Jersey | Newark | New Jersey | United States | 07103 |
| 94 | Newark Beth Israel Medical Center | Newark | New Jersey | United States | 07112 |
| 95 | Garden State Cardiology | Paramus | New Jersey | United States | 07652 |
| 96 | Albany Associates in Cardiology | Albany | New York | United States | 12212 |
| 97 | Cardiology Associates, P.C. | Johnson City | New York | United States | 13790 |
| 98 | North Shore University Hospital | Manhasset | New York | United States | 11030 |
| 99 | St. Vincents Hospital and Medical Center | New York | New York | United States | 10011 |
| 100 | St. Lukes-Roosevelt Hospital Centers | New York | New York | United States | 10019 |
| 101 | New York Presbyterian Hospital | New York | New York | United States | 10032 |
| 102 | St. Francis Hospital | Roslyn | New York | United States | 11576 |
| 103 | SUNY | Syracuse | New York | United States | 13230 |
| 104 | South Bay Cardiovascular Associates | West Islip | New York | United States | 11795 |
| 105 | Buffalo Cardiology and Pulmonary Associates | Williamsville | New York | United States | 14221 |
| 106 | Asheville Cardiology Associates | Asheville | North Carolina | United States | 28803 |
| 107 | Alamance Regional Medical Center | Burlington | North Carolina | United States | 27215 |
| 108 | University of North Carolina | Chapel Hill | North Carolina | United States | 27514 |
| 109 | Mid Carolina Cardiology | Charlotte | North Carolina | United States | 28204 |
| 110 | Durham VA Medical Center | Durham | North Carolina | United States | 27705 |
| 111 | Duke Cardiology Research | Durham | North Carolina | United States | 27710 |
| 112 | Pitt County Memorial Hospital, The Heart Center | Greenville | North Carolina | United States | 28735 |
| 113 | Hendersonville Cardiology | Hendersonville | North Carolina | United States | 28739 |
| 114 | Akron General Medical Center | Akron | Ohio | United States | 44307 |
| 115 | Clinical Research Limited | Canton | Ohio | United States | 44718 |
| 116 | Sterling Research Group | Cincinnati | Ohio | United States | 45219 |
| 117 | The Lindner Clinical Trial Center | Cincinnati | Ohio | United States | 45219 |
| 118 | Midwest Cardiology Research Foundation | Columbus | Ohio | United States | 43214 |
| 119 | The Dayton Heart Center | Dayton | Ohio | United States | 45414 |
| 120 | Cleveland Cardiovascular Research | Fairview Park | Ohio | United States | 44126 |
| 121 | North Ohio Research Limited | Lorain | Ohio | United States | 44052 |
| 122 | North Ohio Research Limited | Sandusky | Ohio | United States | 44870 |
| 123 | Northwest Ohio Cardiology Consultants | Toledo | Ohio | United States | 43615 |
| 124 | Integris Heart Research Center | Oklahoma City | Oklahoma | United States | 73112 |
| 125 | Oklahoma Cardiovascular Research Group | Oklahoma City | Oklahoma | United States | 73120 |
| 126 | Oregon Health and Science University | Portland | Oregon | United States | 97230 |
| 127 | Cardiology Consultants of Philadelphia | Philadelphia | Pennsylvania | United States | 19146 |
| 128 | The Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | United States | 15224 |
| 129 | Guthrie Clinic, LTD | Sayre | Pennsylvania | United States | 18840 |
| 130 | Buxmont Cardiology Associates, PC | Sellersville | Pennsylvania | United States | 18960 |
| 131 | Cardiology Associates of West Reading | West Reading | Pennsylvania | United States | 19611 |
| 132 | Rhode Island Hospital | Providence | Rhode Island | United States | 02905 |
| 133 | Medical University of South Carolina | Charleston | South Carolina | United States | 29401 |
| 134 | Ralph H. Johnson VAMC | Charleston | South Carolina | United States | 29401 |
| 135 | South Carolina Heart Center | Columbia | South Carolina | United States | 29204 |
| 136 | The Chattanooga Heart Institute | Chattanooga | Tennessee | United States | 37404 |
| 137 | Cardiovascular Associates | Kingsport | Tennessee | United States | 37660 |
| 138 | Baptist Clinical Research Center | Memphis | Tennessee | United States | 38120 |
| 139 | Stern Cardiovascular Center | Memphis | Tennessee | United States | 38120 |
| 140 | Vanderbilt Clinical Trials Center | Nashville | Tennessee | United States | 37212 |
| 141 | The Cardiology Group | Tullahoma | Tennessee | United States | 37388 |
| 142 | Austin Cardiovascular Associates | Austin | Texas | United States | 78705 |
| 143 | Southeast Texas Cardiology Associates | Beaumont | Texas | United States | 77702 |
| 144 | Cardiopulmonary Research Science and Technology Institute | Dallas | Texas | United States | 75230 |
| 145 | University of Texas Medical Branch | Galveston | Texas | United States | 77555-0553 |
| 146 | Cardiology Associates Covenant Medical Group | Lubbock | Texas | United States | 79410 |
| 147 | McAllen Heart Clinic | McAllen | Texas | United States | 78503 |
| 148 | University of Texas Health Science Center | San Antonio | Texas | United States | 78229-3900 |
| 149 | Wilford Hall Medical Center, | San Antonio | Texas | United States | 78236 |
| 150 | Scott & White Clinic Division of Cardiology | Temple | Texas | United States | 76508 |
| 151 | VA Salt Lake City Health Care System | Salt Lake City | Utah | United States | 84148 |
| 152 | University of Virginia Medical Center | Charlottesville | Virginia | United States | 22908 |
| 153 | The Cardiovascular Group PC | Fairfax | Virginia | United States | 22031 |
| 154 | Inova Institute of Research | Falls Church | Virginia | United States | 22042 |
| 155 | Medical College of Virginia | Richmond | Virginia | United States | 23219 |
| 156 | Cardiovascular Associates of Virginia | Richmond | Virginia | United States | 23225 |
| 157 | Roanoke Heart Institute | Roanoke | Virginia | United States | 24014 |
| 158 | Empire Health Services | Spokane | Washington | United States | 99204 |
| 159 | Rockwood Clinic | Spokane | Washington | United States | 99204 |
| 160 | CAMC Clinical Trials | Charleston | West Virginia | United States | 25304 |
| 161 | Wisconsin Center For Clinical Research | Elkhorn | Wisconsin | United States | 53121 |
| 162 | Clinica Constituyentes de Moron | Buenos Aires | Argentina | ||
| 163 | Clinica Modelo de Moron | Buenos Aires | Argentina | ||
| 164 | Fundacion Favaloro | Buenos Aires | Argentina | ||
| 165 | Hospital Argerich | Buenos Aires | Argentina | ||
| 166 | Hospital Churruca | Buenos Aires | Argentina | ||
| 167 | Hospital Eva Peron | Buenos Aires | Argentina | ||
| 168 | Hospital Nacional Dr. Alejandro Posadas | Buenos Aires | Argentina | ||
| 169 | Hospital de Clinicas | Capital Federal | Argentina | ||
| 170 | Hospital Fernandez | Capital Federal | Argentina | ||
| 171 | Hospital Italiano de Buenos Aires | Capital Federal | Argentina | ||
| 172 | Hospital Privado Antartida | Capital Federal | Argentina | ||
| 173 | Hospital Ramos Mejia | Capital Federal | Argentina | ||
| 174 | Policlinica Bancaria | Capital Federal | Argentina | ||
| 175 | Sanatorio Municipal "Julio A. Mendez" | Capital Federal | Argentina | ||
| 176 | Hospital Allende | Cordoba | Argentina | ||
| 177 | Hospital Italiano de Cordoba | Cordoba | Argentina | ||
| 178 | Hospital Militar de Cordoba | Cordoba | Argentina | ||
| 179 | Hospital Privado Centro Medico de Cordoba | Cordoba | Argentina | ||
| 180 | Instituto de Cardiologia J. F. Cabral | Corrientes | Argentina | ||
| 181 | Hospital Central de San Isidro | San Isidro | Argentina | ||
| 182 | AZ Middelheim | Antwerpen | Belgium | ||
| 183 | AZ Imelda Ziekenhuis | Bonheiden | Belgium | ||
| 184 | Clinique St Elisabeth Place Louise | Namur | Belgium | ||
| 185 | Cliniques UCL Mont-Godinne | Yvoir | Belgium | ||
| 186 | Hospital Santa Isabel da Santa Casa de Misericordia da Bahia | Salvador | BA | Brazil | 40050-410 |
| 187 | Fundacao Bahiana de Cardiologia- Hospital Universitario Professor Edgard Santos | Salvador | BA | Brazil | 40140-060 |
| 188 | Hospital das Clinicas da Universidade Federal de Goias | Goiania | GO | Brazil | 74605-050 |
| 189 | Hospital Governador Israel Pinheiro | Belo Horizonte | MG | Brazil | 30130-110 |
| 190 | Santa Casa de Misericordia de Belo Horizonte | Belo Horizonte | MG | Brazil | 30150-221 |
| 191 | Hospital Evangelico de Curitiba | Curitiba | PR | Brazil | 80730-150 |
| 192 | Hospital Nossa Senhora das Gracas | Curitiba | PR | Brazil | 80810-040 |
| 193 | Santa Casa de Misericordia do Rio de Janeiro | Rio de Janeiro | RJ | Brazil | 20020-020 |
| 194 | Irmandade da Santa Casa de Misericordia de Porto Alegre | Porto Alegre | RS | Brazil | 90020-090 |
| 195 | Hospital das Clínicas de Porto Alegre | Porto Alegre | RS | Brazil | 90035-003 |
| 196 | Hospital Mae de Deus | Porto Alegre | RS | Brazil | 90880-480 |
| 197 | Hospital Nossa Senhora da Conceica | Porto Alegre | RS | Brazil | 91350-200 |
| 198 | Hospital e Maternidade Celso Pierro | Campinas | SP | Brazil | 13059-740 |
| 199 | Hospital de Base da Faculdade de Medicina de Sao Jose do Rio Preto | Sao Jose de Rio Preto | SP | Brazil | 15090-020 |
| 200 | IMC- Instituto de Molestias Cardiovasculares | Sao Jose do Rio Preto | SP | Brazil | 15015-210 |
| 201 | Instituto do Coracao do Hospital das Clinicas- Faculdade de Medicina da Universidade de Sao Paulo | Sao Paulo | SP | Brazil | 05403-000 |
| 202 | Hospital Universitario Onofre Lopes | Natal | Brazil | 59012-310 | |
| 203 | Hospital das Clínicas de Porto Alegre | Porto Alegre | Brazil | 90035-003 | |
| 204 | Hospital Universitario Pedro Ernesto | Rio de Janeiro | Brazil | 20551-030 | |
| 205 | Peter Loougheed Center | Calgary | Alberta | Canada | T1Y6J4 |
| 206 | Surrey Memorial Hospital | Surrey | British Columbia | Canada | V3V1Z2 |
| 207 | Victoria Heart Institute Foundation | Victoria | British Columbia | Canada | V8R4R2 |
| 208 | St. Boniface General Hospital | Winnipeg | Manitoba | Canada | R2H 2A6 |
| 209 | Health Sciences Center | St. John's | Newfoundland and Labrador | Canada | A1B 3V6 |
| 210 | Brampton Research Associates | Brampton | Ontario | Canada | L6V1B4 |
| 211 | Greater Niagara General Hospital | Niagara Falls | Ontario | Canada | L2E6Y2 |
| 212 | Lakeridge Health Oshawa | Oshawa | Ontario | Canada | L1G2B9 |
| 213 | Scarborough Cardiology Research | Scarborough | Ontario | Canada | M1E5E9 |
| 214 | Cardiology Research Associates | Scarborough | Ontario | Canada | M2S4V5 |
| 215 | The Scarborough Hospital | Toronto | Ontario | Canada | M1P 2V5 |
| 216 | St. Michael's Hospital | Toronto | Ontario | Canada | M5B 1W8 |
| 217 | University Health Network, Toronto Western Hospital | Toronto | Ontario | Canada | M5G 2C4 |
| 218 | Centre Hospitalier de l'Universite de Sherbrooke | Fleurimond | Quebec | Canada | J1H 5N4 |
| 219 | CHRDL | Joliette | Quebec | Canada | J6E6J2 |
| 220 | Invascor Clinical Research | Longueuil | Quebec | Canada | J4M 1E1 |
| 221 | Montreal Heart Institute | Montreal | Quebec | Canada | H1T1C8 |
| 222 | Royal Victoria Hospital | Montreal | Quebec | Canada | H3A1A1 |
| 223 | Montreal General Hospital | Montreal | Quebec | Canada | H3G 1A4 |
| 224 | Hotel-Dieu de Saint-Jerome | Saint Jerome | Quebec | Canada | J7Z 5T3 |
| 225 | I. interni kardio-angiologicka klinika LF MU | Brno | Czech Republic | ||
| 226 | Interni oddeleni | Jablonec nad Nisou | Czech Republic | ||
| 227 | Interni oddeleni | Nachod | Czech Republic | ||
| 228 | Interni klinika, Oddeleni Interna I, Kardiologie | Pardubice | Czech Republic | ||
| 229 | Interni oddeleni | Pisek | Czech Republic | ||
| 230 | I.Interni klinika | Plzen-Lochotin | Czech Republic | ||
| 231 | I.Interni oddeleni | Praha | Czech Republic | ||
| 232 | II.Interni klinika | Praha | Czech Republic | ||
| 233 | Kardiologicka klinika | Praha | Czech Republic | ||
| 234 | Kardiologicke oddeleni | Praha | Czech Republic | ||
| 235 | Klinika kardiologie | Praha | Czech Republic | ||
| 236 | Interni oddeleni | Usti nad Labem | Czech Republic | ||
| 237 | Interni klinika IPVZ | Zlin | Czech Republic | ||
| 238 | Centre Hospitalier Regional d'Arras-Service de Cardiologie | Arras | France | ||
| 239 | Hopital General Henri Duffaut | Avignon | France | ||
| 240 | Centre Hospitalier Jeanne d'Arc | Bar-le-Duc | France | ||
| 241 | Hopital Louis Pradel | Bron cedex | France | ||
| 242 | Cabinet de Cardiologie et d'Explorations | Essey lès Nancy Cedex | France | ||
| 243 | Centre Hospitalier | Langres | France | ||
| 244 | CHU Montpellier | Montpellier | France | ||
| 245 | Centre Hospitalo-Universitaire de Nantes-Service de Cardiologie | Nantes Cedex | France | 44093 | |
| 246 | Hopital Pasteur | Nice | France | ||
| 247 | Centre Cardiologique du Nord | Saint Denis | France | ||
| 248 | Groupe Hospitalier Rangueil-Larrey CHU | Toulouse | France | 31403 | |
| 249 | Centre Hospitalier Universitaire de Nancy-Brabois | Vandoeuvre les Nancy | France | ||
| 250 | Klinikum Augsburg | Augsburg | Germany | ||
| 251 | Herzzentrum Bad Krozingen | Bad Krozingen | Germany | ||
| 252 | Herz- und Gefabklinik Bad Neustadt | Bad Neustadt-Saale | Germany | ||
| 253 | Vivantes Klinikum Neukoln | Berlin | Germany | ||
| 254 | Akademisches Lehrkrankenhaus d. HGS Essen | Essen | Germany | ||
| 255 | Universitatsklinik Essen | Essen | Germany | ||
| 256 | Georg-August-Universitat Gottingen | Gottingen | Germany | ||
| 257 | Universitatsklinikum der | Greifswald | Germany | ||
| 258 | Klinikum der Medizinischen Fakultat | Halle | Germany | ||
| 259 | Universitatsklinikum Eppendorf | Hamburg | Germany | ||
| 260 | Medizinische Universitätsklinik | Heidelberg | Germany | ||
| 261 | Universitatsklinikum Heidelberg | Heidelberg | Germany | ||
| 262 | Universitatsklinikum des Saarland | Homburg/Saar | Germany | ||
| 263 | Friedrich Schiller Universitat Jena | Jena | Germany | ||
| 264 | Klinikum der Universitat zu Koln | Koln | Germany | ||
| 265 | University Leipzig | Leipzig | Germany | ||
| 266 | Universitatsklinikum Munster | Munster | Germany | ||
| 267 | Herz- und Diabetes Zentrum Nordrhein-Westfalen | Oeyenhausen | Germany | ||
| 268 | Universitat Regensburg | Regensburg | Germany | ||
| 269 | Marienkrankenhaus Soest | Soest | Germany | ||
| 270 | Robert-Bosch-Krankenhaus | Stuttgart | Germany | ||
| 271 | Ospedale Civile S. Giuseppe | Albano Laziale | Italy | ||
| 272 | Azienda Ospedaliera S. Michele | Cagliari | Italy | ||
| 273 | Ospedale Civile | Capri | Italy | ||
| 274 | Azienda USL n. 6 Ospedale Civile | Cecina | Italy | ||
| 275 | Poliambulatorio Valdichiana Ospedale di Cortona | Cortona | Italy | ||
| 276 | Centro Cardiologico Monzino | Milano | Italy | ||
| 277 | Ospedale Nigaurda Ca Granda | Milano | Italy | ||
| 278 | Fondazione Salvatore Maugeri | Montescano | Italy | ||
| 279 | Presidio Ospedaliero Villa Sofia | Palmero | Italy | ||
| 280 | Ospedali Riunti | Parma | Italy | ||
| 281 | IRCCS Policlinico S. Matteo | Pavia | Italy | ||
| 282 | IRCCS- Fondazione Salvatore Maugeri | Pavia | Italy | ||
| 283 | Ospedale S. Maria delle Grazie | Pozzuoli | Italy | ||
| 284 | Ospedale S. Bartolomeo | Sarzana | Italy | ||
| 285 | Ospedali Civile SS Annunziata | Sassari | Italy | ||
| 286 | Sint Lucas Andreas Ziekenhuis (loc. Lucas) | Amsterdam | Netherlands | ||
| 287 | Gelre Ziekenhuis (location Juliana) | Apeldoorn | Netherlands | ||
| 288 | Ziekenhuis Gooi Noord | Blaricum | Netherlands | ||
| 289 | Jeroen Bosch Ziekenhus (location Groot Ziekengasthius=GZG) | Den Bosch | Netherlands | ||
| 290 | Medisch Centrum Haaglanden (location Westeinde) | Den Haag | Netherlands | ||
| 291 | Deventer Ziekenhuis | Deventer | Netherlands | ||
| 292 | Ziekenhuis Gelderse Vallei | Ede | Netherlands | ||
| 293 | Medisch Spectrum Twente | Enschede | Netherlands | ||
| 294 | Oosterschelde Ziekenhuizen | Goes | Netherlands | ||
| 295 | Martini Ziekenhuis (Loc. Martini Paviljoen) | Groningen | Netherlands | ||
| 296 | Spaarne Ziekenhuis | Heemstede | Netherlands | ||
| 297 | Ziekenhuis Hilversum | Hilversum | Netherlands | ||
| 298 | Canisius-Wilhelmina Ziekenhuis | Nijmegen | Netherlands | ||
| 299 | Isala Klinieken (Loc. Sophia) | Zwolle | Netherlands | ||
| 300 | Hjerte med. Avd. Haukeland Universitets Sykehus | Bergen | Norway | ||
| 301 | Nordlandsykehuset | Bodo | Norway | ||
| 302 | Hjertemed.avd. Akershus Universitetssykenhus | Nordbyhagen | Norway | ||
| 303 | Diakonhjemmets sykehus Oslo | Oslo | Norway | ||
| 304 | Med. Avd. Sykenhuset Telemark | Skien | Norway | ||
| 305 | Stavanger Helseforskning | Stavanger | Norway | ||
| 306 | Oddzial Kardiologii | Bydgoszcz | Poland | ||
| 307 | Oddzial Kardiologii | Krakow | Poland | ||
| 308 | Oddzial Kardiologii | Lodz | Poland | ||
| 309 | Oddzial Chorob Wewnetrznych | Olawa | Poland | ||
| 310 | Oddzial Kardiologiczny | Opole | Poland | ||
| 311 | Oddzial Kardiologii | Ostrowiec Swietokrzyski | Poland | ||
| 312 | Oddzial Kardiologiczny | Piotrków Trybunalski | Poland | ||
| 313 | Oddzial Kardiologiczny | Plock | Poland | ||
| 314 | Oddzial Kardiologii | Sieradz | Poland | ||
| 315 | Oddzial Kardiologii | Torun | Poland | ||
| 316 | Katedra i Oddzial Kliniczny Kardiologii Slaskiej Akademii | Tychy | Poland | ||
| 317 | I Klinika Choroby Wiencowej | Warszawa | Poland | ||
| 318 | Katedra i Klinika Chorab Wewnetrznych i Kardiologii | Warszawa | Poland | ||
| 319 | Oddzial Kardiologii | Wloclawek | Poland | ||
| 320 | Spitalul Judetean Brasov, Sectia de Cardiologie | Brasov | Romania | ||
| 321 | Institutul de Boli Cardiovasculare | Bucharest | Romania | ||
| 322 | Spitalul Caritas, Clinica Medicala | Bucharest | Romania | ||
| 323 | Spitalul de Urgenta Floreasca, Clinica de Cardiologie | Bucharest | Romania | ||
| 324 | Spitalul Universitar de Urgenta Bucuresti | Bucharest | Romania | ||
| 325 | Spitalul Universitar de Urgenta | Bucuresti | Romania | ||
| 326 | Institutul Inimii, Prof.N. Stancioiu | Cluj-Napoca | Romania | ||
| 327 | Centrul de Cardiologie Craiova | Craiova | Romania | ||
| 328 | Spitalul Clinic Universitar ,,Sf. Spiridon" | Iasi | Romania | ||
| 329 | Spitalul Clinic Judetean Mures | Targu-Mures | Romania | ||
| 330 | Institutul de Boli Cardiovasculare Timisoara | Timisoara | Romania | ||
| 331 | Botkins Moscow City Hospital | Moscow | Russian Federation | ||
| 332 | Burdenko Main Military Clinical Hospital | Moscow | Russian Federation | ||
| 333 | Cardiology Research Center | Moscow | Russian Federation | ||
| 334 | Central Clinical Hospital Presidential | Moscow | Russian Federation | ||
| 335 | City Clinical Hospital 2 | Moscow | Russian Federation | ||
| 336 | Institute of Physico-Chemical Medicine | Moscow | Russian Federation | ||
| 337 | Medical Center of General Management | Moscow | Russian Federation | ||
| 338 | Moscow Medical Academy | Moscow | Russian Federation | ||
| 339 | Moscow Regional Research Clinical Institute n.a. Vishnevsky | Moscow | Russian Federation | ||
| 340 | Moscow State University of Medicine and Dentistry - City Hospital #11 | Moscow | Russian Federation | ||
| 341 | Moscow State University of Medicine and Dentistry - City Hospital #40 | Moscow | Russian Federation | ||
| 342 | Moscow State University of Medicine and Dentistry | Moscow | Russian Federation | ||
| 343 | Russian State Medical University | Moscow | Russian Federation | ||
| 344 | Veterans Hospital #3 | Moscow | Russian Federation | ||
| 345 | Cardiology Research Institute of the Ministry of Health of the Russian Federation | St. Petersburg | Russian Federation | ||
| 346 | City Alexandrovsky Hospital, ICU Department | St. Petersburg | Russian Federation | ||
| 347 | City Hospital #31 | St. Petersburg | Russian Federation | ||
| 348 | City Hospital 8 | St. Petersburg | Russian Federation | ||
| 349 | Military Medical Academy | St. Petersburg | Russian Federation | ||
| 350 | St. Elisabeth City Hospital | St. Petersburg | Russian Federation | ||
| 351 | St. Petersburg Clinical Hospital of Russian Academy of Sciences | St. Petersburg | Russian Federation | ||
| 352 | St. Petersburg Dzanelidze State Scientific Research Institute for Emergency Medical Care | St. Petersburg | Russian Federation | ||
| 353 | St. Petersburg Medical Postgraduate Academy | St. Petersburg | Russian Federation | ||
| 354 | St. Petersburg State University | St. Petersburg | Russian Federation | ||
| 355 | Hospital de Torrecardenas | Almeria | Spain | ||
| 356 | Hospital Clinic y Provincial | Barcelona | Spain | ||
| 357 | Hospital de Cruces | Bilbao | Spain | ||
| 358 | Hospital Reina Sofia, in Cordoba | Cordoba | Spain | ||
| 359 | Hospital Doce de Octubre | Madrid | Spain | ||
| 360 | Hospital Severo Ochoa | Madrid | Spain | ||
| 361 | Hospital Universitari de Tarragona Joan XXIII | Tarragona | Spain | ||
| 362 | Hospital General Universitario de Valencia | Valencia | Spain | ||
| 363 | Medicinkliniken | Goteborg | Sweden | ||
| 364 | Avd. for intermedicin | Gothenburg | Sweden | ||
| 365 | Kardiologkliniken | Linkoping | Sweden | ||
| 366 | Kardiologkliniken | Malmo | Sweden | ||
| 367 | Forskiningsenheten, | Molndal | Sweden | ||
| 368 | Enheten for internmedicin, Karolinska Institutet | Stockholm | Sweden | ||
| 369 | Hjartkliniken, M84 | Stockholm | Sweden | ||
| 370 | Kardiologkliniken | Stockholm | Sweden | ||
| 371 | Hjartcentrum, | Umea | Sweden | ||
| 372 | Cardiologkliniken, Avd 50F | Uppsala | Sweden | ||
| 373 | Cardiocentro Ticino | Lugano | Switzerland | ||
| 374 | Bradford Royal Infirmary | Bradford | United Kingdom | ||
| 375 | Castle Hill Hospital | Cottingham | United Kingdom | ||
| 376 | Leeds General Infirmary | Leeds | United Kingdom | ||
| 377 | Northern Manchester General Hospital | Manchester | United Kingdom | ||
| 378 | Scunthorpe General Hospital | Scunthorpe | United Kingdom |
Sponsors and Collaborators
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00071331
Other Study ID Numbers:
- 156-03-236
First Posted:
Oct 21, 2003
Last Update Posted:
May 3, 2012
Last Verified:
May 1, 2012
Keywords provided by ,
,
Additional relevant MeSH terms: