Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00279045
Collaborator
(none)
4,426
490
77.5
9
0.1
Study Details
Study Description
Brief Summary
The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
4426 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind Study to Compare the Durability of Glucose Lowering and Preservation of Pancreatic Beta-Cell Function of Rosiglitazone Monotherapy Compared to Metformin or Glyburide/Glibenclamide in Patients With Drug-Naive, Recently Diagnosed Type 2 Diabetes Mellitus
Study Start Date
:
Jan 3, 2000
Actual Primary Completion Date
:
Jun 1, 2006
Actual Study Completion Date
:
Jun 19, 2006
Outcome Measures
Primary Outcome Measures
- Time from randomization to the primary action point (monotherapy failure). []
Secondary Outcome Measures
- Comparison of effects of long-term treatment with Rosiglitazone, Metformin, Glyburide: - maintenance/restoration of beta-cell function: HOMA IS, progression of microalbuminuria, fibrinolytic markers (PAI-1,fibrinogen, CRP). []
Eligibility Criteria
Criteria
Ages Eligible for Study:
30 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
-
Newly diagnosed patients (< 3years) with type 2 diabetes.
-
Fasting plasma glucose (FPG) range of 126-240 mg/dL at Screening.
-
No previous treatment with oral or parenteral glucose-lowering therapy.
Exclusion criteria:
-
History of lactic acidosis.
-
Anemia (<11g for males, <10 g for females).
-
Unstable or severe NY Heart Association-class 3 or 4.
-
Any NY Heart Association congestive heart failure.
-
Patients with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Anniston | Alabama | United States | 36207 |
| 2 | GSK Investigational Site | Birmingham | Alabama | United States | 35233 |
| 3 | GSK Investigational Site | Mesa | Arizona | United States | 85206 |
| 4 | GSK Investigational Site | Tucson | Arizona | United States | 85723 |
| 5 | GSK Investigational Site | Little Rock | Arkansas | United States | 77205 |
| 6 | GSK Investigational Site | Berkeley | California | United States | 94705 |
| 7 | GSK Investigational Site | Corona | California | United States | 92879 |
| 8 | GSK Investigational Site | Fair Oaks | California | United States | 95628 |
| 9 | GSK Investigational Site | Fremont | California | United States | 94538 |
| 10 | GSK Investigational Site | Fresno | California | United States | 93720 |
| 11 | GSK Investigational Site | Fullerton | California | United States | 92835 |
| 12 | GSK Investigational Site | Greenbrae | California | United States | 94904 |
| 13 | GSK Investigational Site | Harbor City | California | United States | 90710 |
| 14 | GSK Investigational Site | Healdsburg | California | United States | 95448 |
| 15 | GSK Investigational Site | La Jolla | California | United States | 92037 |
| 16 | GSK Investigational Site | Loma Linda | California | United States | 92354 |
| 17 | GSK Investigational Site | Los Angeles | California | United States | 90059 |
| 18 | GSK Investigational Site | Los Angeles | California | United States | 90095 |
| 19 | GSK Investigational Site | Modesto | California | United States | 95355 |
| 20 | GSK Investigational Site | Pasadena | California | United States | 91105 |
| 21 | GSK Investigational Site | San Diego | California | United States | 92126 |
| 22 | GSK Investigational Site | San Francisco | California | United States | 94143 |
| 23 | GSK Investigational Site | Santa Rosa | California | United States | 95405 |
| 24 | GSK Investigational Site | Sunnyvale | California | United States | 94086 |
| 25 | GSK Investigational Site | Ukiah | California | United States | 95482 |
| 26 | GSK Investigational Site | Walnut Creek | California | United States | 94598 |
| 27 | GSK Investigational Site | Yorba Linda | California | United States | 92886 |
| 28 | GSK Investigational Site | Boulder | Colorado | United States | 80304 |
| 29 | GSK Investigational Site | Denver | Colorado | United States | 80209 |
| 30 | GSK Investigational Site | Denver | Colorado | United States | 80220 |
| 31 | GSK Investigational Site | Englewood | Colorado | United States | 80110 |
| 32 | GSK Investigational Site | Longmont | Colorado | United States | 80501 |
| 33 | GSK Investigational Site | Wheat Ridge | Colorado | United States | 80033 |
| 34 | GSK Investigational Site | Wheat Ridge | Colorado | United States | 80043 |
| 35 | GSK Investigational Site | Washington | District of Columbia | United States | 20003 |
| 36 | GSK Investigational Site | Washington | District of Columbia | United States | 20037 |
| 37 | GSK Investigational Site | Fort Myers | Florida | United States | 33907 |
| 38 | GSK Investigational Site | Hollywood | Florida | United States | 33023 |
| 39 | GSK Investigational Site | Jacksonville | Florida | United States | 32204 |
| 40 | GSK Investigational Site | Jacksonville | Florida | United States | 32216 |
| 41 | GSK Investigational Site | Melbourne | Florida | United States | 32935 |
| 42 | GSK Investigational Site | Miami | Florida | United States | 33136 |
| 43 | GSK Investigational Site | Miami | Florida | United States | 33176 |
| 44 | GSK Investigational Site | Orlando | Florida | United States | 32806 |
| 45 | GSK Investigational Site | Palm Harbor | Florida | United States | 34683 |
| 46 | GSK Investigational Site | Saint Petersburg | Florida | United States | 33702 |
| 47 | GSK Investigational Site | Saint Petersburg | Florida | United States | 33710 |
| 48 | GSK Investigational Site | Sarasota | Florida | United States | 34239 |
| 49 | GSK Investigational Site | Tampa | Florida | United States | 33612 |
| 50 | GSK Investigational Site | Titusville | Florida | United States | 32796 |
| 51 | GSK Investigational Site | West Palm Beach | Florida | United States | 33401 |
| 52 | GSK Investigational Site | Atlanta | Georgia | United States | 30308 |
| 53 | GSK Investigational Site | Atlanta | Georgia | United States | 30312 |
| 54 | GSK Investigational Site | Atlanta | Georgia | United States | 30322 |
| 55 | GSK Investigational Site | Atlanta | Georgia | United States | 30328 |
| 56 | GSK Investigational Site | Atlanta | Georgia | United States | 30338 |
| 57 | GSK Investigational Site | Blue Ridge | Georgia | United States | 30513 |
| 58 | GSK Investigational Site | Dunwoody | Georgia | United States | 30338 |
| 59 | GSK Investigational Site | Fayetteville | Georgia | United States | 30214 |
| 60 | GSK Investigational Site | Honolulu | Hawaii | United States | 96813 |
| 61 | GSK Investigational Site | Boise | Idaho | United States | 83706 |
| 62 | GSK Investigational Site | Chicago | Illinois | United States | 60612 |
| 63 | GSK Investigational Site | Gurnee | Illinois | United States | 60031 |
| 64 | GSK Investigational Site | Springfield | Illinois | United States | 62704 |
| 65 | GSK Investigational Site | Evansville | Indiana | United States | 47713 |
| 66 | GSK Investigational Site | Indianapolis | Indiana | United States | 46202 |
| 67 | GSK Investigational Site | Indianapolis | Indiana | United States | 46250 |
| 68 | GSK Investigational Site | Lexington | Kentucky | United States | 40504-2681 |
| 69 | GSK Investigational Site | Lake Charles | Louisiana | United States | 70601 |
| 70 | GSK Investigational Site | New Orleans | Louisiana | United States | 70119 |
| 71 | GSK Investigational Site | Slidell | Louisiana | United States | 70458 |
| 72 | GSK Investigational Site | Slidell | Louisiana | United States | 70461 |
| 73 | GSK Investigational Site | Bangor | Maine | United States | 04401 |
| 74 | GSK Investigational Site | Baltimore | Maryland | United States | 21201 |
| 75 | GSK Investigational Site | Baltimore | Maryland | United States | 21204 |
| 76 | GSK Investigational Site | Baltimore | Maryland | United States | 21205 |
| 77 | GSK Investigational Site | Baltimore | Maryland | United States | 21208 |
| 78 | GSK Investigational Site | Boston | Massachusetts | United States | 02114 |
| 79 | GSK Investigational Site | Springfield | Massachusetts | United States | 01199 |
| 80 | GSK Investigational Site | Ann Arbor | Michigan | United States | 48109 |
| 81 | GSK Investigational Site | Detroit | Michigan | United States | 48201 |
| 82 | GSK Investigational Site | Lansing | Michigan | United States | 48912 |
| 83 | GSK Investigational Site | Royal Oak | Michigan | United States | 48073 |
| 84 | GSK Investigational Site | Minneapolis | Minnesota | United States | 55404 |
| 85 | GSK Investigational Site | Minneapolis | Minnesota | United States | 55407-3799 |
| 86 | GSK Investigational Site | Minneapolis | Minnesota | United States | 55416 |
| 87 | GSK Investigational Site | Jackson | Mississippi | United States | 39202 |
| 88 | GSK Investigational Site | Olive Branch | Mississippi | United States | 38654 |
| 89 | GSK Investigational Site | Kansas City | Missouri | United States | 64132 |
| 90 | GSK Investigational Site | Saint Louis | Missouri | United States | 63110 |
| 91 | GSK Investigational Site | Saint Louis | Missouri | United States | 63128 |
| 92 | GSK Investigational Site | Billings | Montana | United States | 59102 |
| 93 | GSK Investigational Site | Omaha | Nebraska | United States | 68105 |
| 94 | GSK Investigational Site | Omaha | Nebraska | United States | 68131 |
| 95 | GSK Investigational Site | Henderson | Nevada | United States | 89014 |
| 96 | GSK Investigational Site | Cherry Hill | New Jersey | United States | 08034 |
| 97 | GSK Investigational Site | Cherry Hill | New Jersey | United States | 8034 |
| 98 | GSK Investigational Site | Albuquerque | New Mexico | United States | 87102 |
| 99 | GSK Investigational Site | Albuquerque | New Mexico | United States | 87106 |
| 100 | GSK Investigational Site | Albuquerque | New Mexico | United States | 87109 |
| 101 | GSK Investigational Site | Albany | New York | United States | 12206 |
| 102 | GSK Investigational Site | Bronx | New York | United States | 10461 |
| 103 | GSK Investigational Site | Endwell | New York | United States | 13760 |
| 104 | GSK Investigational Site | Flushing | New York | United States | 11365 |
| 105 | GSK Investigational Site | New York | New York | United States | 10003 |
| 106 | GSK Investigational Site | New York | New York | United States | 10010 |
| 107 | GSK Investigational Site | New York | New York | United States | 10021 |
| 108 | GSK Investigational Site | New York | New York | United States | 10029 |
| 109 | GSK Investigational Site | New York | New York | United States | 10032 |
| 110 | GSK Investigational Site | Rochester | New York | United States | 14609 |
| 111 | GSK Investigational Site | Rochester | New York | United States | 14642 |
| 112 | GSK Investigational Site | Syracuse | New York | United States | 13210 |
| 113 | GSK Investigational Site | Durham | North Carolina | United States | 27710 |
| 114 | GSK Investigational Site | Cincinnati | Ohio | United States | 45219 |
| 115 | GSK Investigational Site | Cleveland | Ohio | United States | 44121 |
| 116 | GSK Investigational Site | Cleveland | Ohio | United States | 44195 |
| 117 | GSK Investigational Site | Mogadore | Ohio | United States | 44260 |
| 118 | GSK Investigational Site | Westlake | Ohio | United States | 44145 |
| 119 | GSK Investigational Site | Oklahoma City | Oklahoma | United States | 73104 |
| 120 | GSK Investigational Site | Bend | Oregon | United States | 97701 |
| 121 | GSK Investigational Site | Eugene | Oregon | United States | 97401 |
| 122 | GSK Investigational Site | Portland | Oregon | United States | 97219 |
| 123 | GSK Investigational Site | Portland | Oregon | United States | 97239 |
| 124 | GSK Investigational Site | Downingtown | Pennsylvania | United States | 19335 |
| 125 | GSK Investigational Site | Feasterville | Pennsylvania | United States | 19053 |
| 126 | GSK Investigational Site | Fleetwood | Pennsylvania | United States | 19522 |
| 127 | GSK Investigational Site | Hermitage | Pennsylvania | United States | 16148 |
| 128 | GSK Investigational Site | Hershey | Pennsylvania | United States | 17033 |
| 129 | GSK Investigational Site | Jefferson Hills | Pennsylvania | United States | 15025 |
| 130 | GSK Investigational Site | Philadelphia | Pennsylvania | United States | 19104 |
| 131 | GSK Investigational Site | Philadelphia | Pennsylvania | United States | 19107 |
| 132 | GSK Investigational Site | Philadelphia | Pennsylvania | United States | 19115 |
| 133 | GSK Investigational Site | Philadelphia | Pennsylvania | United States | 19148 |
| 134 | GSK Investigational Site | Pittsburgh | Pennsylvania | United States | 15219 |
| 135 | GSK Investigational Site | Upland | Pennsylvania | United States | 19013 |
| 136 | GSK Investigational Site | Warminster | Pennsylvania | United States | 18974 |
| 137 | GSK Investigational Site | West Chester | Pennsylvania | United States | 19380 |
| 138 | GSK Investigational Site | Charleston | South Carolina | United States | 29403 |
| 139 | GSK Investigational Site | Columbia | South Carolina | United States | 29201 |
| 140 | GSK Investigational Site | Greer | South Carolina | United States | 29651 |
| 141 | GSK Investigational Site | Spartanburg | South Carolina | United States | 29303 |
| 142 | GSK Investigational Site | Bristol | Tennessee | United States | 37620 |
| 143 | GSK Investigational Site | Nashville | Tennessee | United States | 37211 |
| 144 | GSK Investigational Site | Arlington | Texas | United States | 76014 |
| 145 | GSK Investigational Site | Austin | Texas | United States | 78745 |
| 146 | GSK Investigational Site | Beaumont | Texas | United States | 77701 |
| 147 | GSK Investigational Site | Corpus Christi | Texas | United States | 78411 |
| 148 | GSK Investigational Site | Corpus Christi | Texas | United States | 78412 |
| 149 | GSK Investigational Site | Dallas | Texas | United States | 75230 |
| 150 | GSK Investigational Site | Dallas | Texas | United States | 75231 |
| 151 | GSK Investigational Site | Dallas | Texas | United States | 75390 |
| 152 | GSK Investigational Site | Fort Worth | Texas | United States | 76107 |
| 153 | GSK Investigational Site | Houston | Texas | United States | 77024 |
| 154 | GSK Investigational Site | Houston | Texas | United States | 77030 |
| 155 | GSK Investigational Site | Irving | Texas | United States | 75061 |
| 156 | GSK Investigational Site | Midland | Texas | United States | 79705 |
| 157 | GSK Investigational Site | San Antonio | Texas | United States | 78207 |
| 158 | GSK Investigational Site | San Antonio | Texas | United States | 78229 |
| 159 | GSK Investigational Site | Ogden | Utah | United States | 84403 |
| 160 | GSK Investigational Site | Salt Lake City | Utah | United States | 84103 |
| 161 | GSK Investigational Site | Salt Lake City | Utah | United States | 84108 |
| 162 | GSK Investigational Site | Charlottesville | Virginia | United States | 22908 |
| 163 | GSK Investigational Site | Newport News | Virginia | United States | 23606 |
| 164 | GSK Investigational Site | Richmond | Virginia | United States | 23249 |
| 165 | GSK Investigational Site | Salem | Virginia | United States | 24153 |
| 166 | GSK Investigational Site | Federal Way | Washington | United States | 98003 |
| 167 | GSK Investigational Site | Seattle | Washington | United States | 98104 |
| 168 | GSK Investigational Site | Seattle | Washington | United States | 98108 |
| 169 | GSK Investigational Site | Seattle | Washington | United States | 98195 |
| 170 | GSK Investigational Site | Spokane | Washington | United States | 99204 |
| 171 | GSK Investigational Site | Spokane | Washington | United States | 99207 |
| 172 | GSK Investigational Site | Spokane | Washington | United States | 99208 |
| 173 | GSK Investigational Site | Wenatchee | Washington | United States | 98801 |
| 174 | GSK Investigational Site | Charleston | West Virginia | United States | 25304 |
| 175 | GSK Investigational Site | Huntington | West Virginia | United States | 25701 |
| 176 | GSK Investigational Site | Madison | Wisconsin | United States | 53717 |
| 177 | GSK Investigational Site | Milwaukee | Wisconsin | United States | 53209 |
| 178 | GSK Investigational Site | Oregon | Wisconsin | United States | 53575 |
| 179 | GSK Investigational Site | Vienna | Austria | A-1080 | |
| 180 | GSK Investigational Site | Vienna | Austria | A-1130 | |
| 181 | GSK Investigational Site | Wiener Neustadt | Austria | A-2700 | |
| 182 | GSK Investigational Site | Blankenberge | Belgium | 8370 | |
| 183 | GSK Investigational Site | Boechout | Belgium | 2530 | |
| 184 | GSK Investigational Site | Deurne | Belgium | 2100 | |
| 185 | GSK Investigational Site | Leuven | Belgium | 3000 | |
| 186 | GSK Investigational Site | Lubbeek (Linden) | Belgium | B-3210 | |
| 187 | GSK Investigational Site | Tielt | Belgium | 8700 | |
| 188 | GSK Investigational Site | Wezembeek-Oppem | Belgium | 1970 | |
| 189 | GSK Investigational Site | Wijnegem | Belgium | 2110 | |
| 190 | GSK Investigational Site | Zemst | Belgium | 1980 | |
| 191 | GSK Investigational Site | Calgary | Alberta | Canada | T2R 0X7 |
| 192 | GSK Investigational Site | Edmonton | Alberta | Canada | T5N 3Y6 |
| 193 | GSK Investigational Site | Edmonton | Alberta | Canada | T6G 2C8 |
| 194 | GSK Investigational Site | Red Deer | Alberta | Canada | T4N 6V7 |
| 195 | GSK Investigational Site | Coquitlam | British Columbia | Canada | V3K 3P4 |
| 196 | GSK Investigational Site | Vancouver | British Columbia | Canada | V5Z 1M9 |
| 197 | GSK Investigational Site | Victoria | British Columbia | Canada | V8R 6T9 |
| 198 | GSK Investigational Site | Winnipeg | Manitoba | Canada | R2H 2A6 |
| 199 | GSK Investigational Site | Winnipeg | Manitoba | Canada | R3E 3P4 |
| 200 | GSK Investigational Site | Cambellton | New Brunswick | Canada | E3N 3S8 |
| 201 | GSK Investigational Site | Moncton | New Brunswick | Canada | E1C 6Z8 |
| 202 | GSK Investigational Site | Saint John's | Newfoundland and Labrador | Canada | A1B 3V6 |
| 203 | GSK Investigational Site | Antigonish | Nova Scotia | Canada | B2G 2C2 |
| 204 | GSK Investigational Site | Halifax | Nova Scotia | Canada | B3H 1V7 |
| 205 | GSK Investigational Site | Burlington | Ontario | Canada | L7M 4Y1 |
| 206 | GSK Investigational Site | Kingston | Ontario | Canada | K7L 2V7 |
| 207 | GSK Investigational Site | London | Ontario | Canada | N6A 4V2 |
| 208 | GSK Investigational Site | Mississauga | Ontario | Canada | L5M 2N1 |
| 209 | GSK Investigational Site | Oakville | Ontario | Canada | L6H 3P1 |
| 210 | GSK Investigational Site | Ottawa | Ontario | Canada | K1H 7W9 |
| 211 | GSK Investigational Site | Sudbury | Ontario | Canada | P3A 1Y8 |
| 212 | GSK Investigational Site | Thornhill | Ontario | Canada | L4J 1V8 |
| 213 | GSK Investigational Site | Thunder Bay | Ontario | Canada | P7B 2Z3 |
| 214 | GSK Investigational Site | Timmins | Ontario | Canada | P4N 8P2 |
| 215 | GSK Investigational Site | Toronto | Ontario | Canada | M5C 2T2 |
| 216 | GSK Investigational Site | Windsor | Ontario | Canada | N8X 1K4 |
| 217 | GSK Investigational Site | Charlottetown | Prince Edward Island | Canada | C1A 1L2 |
| 218 | GSK Investigational Site | Chicoutimi | Quebec | Canada | G7H 5H6 |
| 219 | GSK Investigational Site | La Malbaie | Quebec | Canada | G5A 1W7 |
| 220 | GSK Investigational Site | Laval | Quebec | Canada | H7T 2P5 |
| 221 | GSK Investigational Site | Montreal | Quebec | Canada | H1T 2M4 |
| 222 | GSK Investigational Site | Montreal | Quebec | Canada | H2W 1T8 |
| 223 | GSK Investigational Site | Plessisville | Quebec | Canada | G6L 3J1 |
| 224 | GSK Investigational Site | Saint Marc Des Carrieres | Quebec | Canada | G0A 4B0 |
| 225 | GSK Investigational Site | Sainte-Foy | Quebec | Canada | G1V 4G5 |
| 226 | GSK Investigational Site | Sherbrooke | Quebec | Canada | J1H 5N4 |
| 227 | GSK Investigational Site | St-Isidore De Dorchester | Quebec | Canada | G0S 2S0 |
| 228 | GSK Investigational Site | Regina | Saskatchewan | Canada | S4P 0W5 |
| 229 | GSK Investigational Site | Saskatoon | Saskatchewan | Canada | S7N 0W8 |
| 230 | GSK Investigational Site | Ostrava | Czechia | 703 52 | |
| 231 | GSK Investigational Site | Phaha 5 | Czechia | 150 06 | |
| 232 | GSK Investigational Site | Praha 4 | Czechia | 142 00 | |
| 233 | GSK Investigational Site | Usti Nad Labem | Czechia | 401 13 | |
| 234 | GSK Investigational Site | Zlin | Czechia | 762 75 | |
| 235 | GSK Investigational Site | Frederiksberg C | Denmark | 1900 | |
| 236 | GSK Investigational Site | Odense | Denmark | 5000 | |
| 237 | GSK Investigational Site | Hanko | Finland | 10900 | |
| 238 | GSK Investigational Site | Helsinki | Finland | 00150 | |
| 239 | GSK Investigational Site | Jyvaskyla | Finland | 40100 | |
| 240 | GSK Investigational Site | Lmatra | Finland | 55800 | |
| 241 | GSK Investigational Site | Savitaipale | Finland | 54800 | |
| 242 | GSK Investigational Site | Alben | France | 73410 | |
| 243 | GSK Investigational Site | Bezier | France | 34500 | |
| 244 | GSK Investigational Site | Bourges | France | 18000 | |
| 245 | GSK Investigational Site | Brogile | France | 27270 | |
| 246 | GSK Investigational Site | Chartres | France | 28000 | |
| 247 | GSK Investigational Site | Denguin | France | 64230 | |
| 248 | GSK Investigational Site | Evreux | France | 27000 | |
| 249 | GSK Investigational Site | Gamarde Les Bains | France | 40380 | |
| 250 | GSK Investigational Site | La Rochelle | France | 17000 | |
| 251 | GSK Investigational Site | Labarthe Sur Leze | France | 31860 | |
| 252 | GSK Investigational Site | Le Mans | France | 72000 | |
| 253 | GSK Investigational Site | Le Pian Medoc | France | 33290 | |
| 254 | GSK Investigational Site | Lille | France | 59000 | |
| 255 | GSK Investigational Site | Mallemort | France | 13370 | |
| 256 | GSK Investigational Site | Marseille | France | 13001 | |
| 257 | GSK Investigational Site | Marseille | France | 13008 | |
| 258 | GSK Investigational Site | Marsillargues | France | 34590 | |
| 259 | GSK Investigational Site | Marssac | France | 81150 | |
| 260 | GSK Investigational Site | Mont De Marsen | France | 40000 | |
| 261 | GSK Investigational Site | Montignac | France | 24290 | |
| 262 | GSK Investigational Site | Moulon | France | 33420 | |
| 263 | GSK Investigational Site | Murs Erigne | France | 49610 | |
| 264 | GSK Investigational Site | Nantes Cedex 01 | France | 44093 | |
| 265 | GSK Investigational Site | Nantes | France | 44300 | |
| 266 | GSK Investigational Site | Nimes | France | 30900 | |
| 267 | GSK Investigational Site | Orthez | France | 64300 | |
| 268 | GSK Investigational Site | Paris | France | 75015 | |
| 269 | GSK Investigational Site | Rennes | France | 35200 | |
| 270 | GSK Investigational Site | Roanna | France | 42300 | |
| 271 | GSK Investigational Site | Saint Etienne | France | 42000 | |
| 272 | GSK Investigational Site | Saint Genies Des Fontaines | France | 66740 | |
| 273 | GSK Investigational Site | Sisteron | France | 04200 | |
| 274 | GSK Investigational Site | St Julien Des Landes | France | 85150 | |
| 275 | GSK Investigational Site | St Martin D'Heres | France | 38400 | |
| 276 | GSK Investigational Site | St Pierre de Chandieu | France | 69780 | |
| 277 | GSK Investigational Site | Strasbourg | France | 67000 | |
| 278 | GSK Investigational Site | Tarare | France | 69170 | |
| 279 | GSK Investigational Site | Vieux Conde | France | 59690 | |
| 280 | GSK Investigational Site | Vourey | France | 38210 | |
| 281 | GSK Investigational Site | Bad Rappenau | Baden-Wuerttemberg | Germany | 74906 |
| 282 | GSK Investigational Site | Deggingen | Baden-Wuerttemberg | Germany | 73326 |
| 283 | GSK Investigational Site | Mannheim | Baden-Wuerttemberg | Germany | 68161 |
| 284 | GSK Investigational Site | Trochtelfingen | Baden-Wuerttemberg | Germany | 72818 |
| 285 | GSK Investigational Site | Unterschneidheim | Baden-Wuerttemberg | Germany | 73485 |
| 286 | GSK Investigational Site | Wangen | Baden-Wuerttemberg | Germany | 88239 |
| 287 | GSK Investigational Site | Weinheim | Baden-Wuerttemberg | Germany | 69469 |
| 288 | GSK Investigational Site | Aschaffenburg | Bayern | Germany | 63739 |
| 289 | GSK Investigational Site | Haag | Bayern | Germany | 83527 |
| 290 | GSK Investigational Site | Hoehenkirchen-Siegertsbrunn | Bayern | Germany | 85635 |
| 291 | GSK Investigational Site | Ismaning | Bayern | Germany | 85737 |
| 292 | GSK Investigational Site | Krummenaab | Bayern | Germany | 92703 |
| 293 | GSK Investigational Site | Kuenzing | Bayern | Germany | 94550 |
| 294 | GSK Investigational Site | Landshut | Bayern | Germany | 84028 |
| 295 | GSK Investigational Site | Muenchen | Bayern | Germany | 80339 |
| 296 | GSK Investigational Site | Muenchen | Bayern | Germany | 80469 |
| 297 | GSK Investigational Site | Muenchen | Bayern | Germany | 80805 |
| 298 | GSK Investigational Site | Muenchen | Bayern | Germany | 80807 |
| 299 | GSK Investigational Site | Muenchen | Bayern | Germany | 80937 |
| 300 | GSK Investigational Site | Muenchen | Bayern | Germany | 81379 |
| 301 | GSK Investigational Site | Nuernberg | Bayern | Germany | 90427 |
| 302 | GSK Investigational Site | Wallerfing | Bayern | Germany | 94574 |
| 303 | GSK Investigational Site | Bad Kreuznach | Hessen | Germany | 55545 |
| 304 | GSK Investigational Site | Frankfurt | Hessen | Germany | 60326 |
| 305 | GSK Investigational Site | Grossalmerode | Hessen | Germany | 37247 |
| 306 | GSK Investigational Site | Lollar | Hessen | Germany | 35475 |
| 307 | GSK Investigational Site | Offenbach | Hessen | Germany | 63065 |
| 308 | GSK Investigational Site | Offenbach | Hessen | Germany | 63067 |
| 309 | GSK Investigational Site | Offenbach | Hessen | Germany | 63071 |
| 310 | GSK Investigational Site | Offenbach | Hessen | Germany | 63073 |
| 311 | GSK Investigational Site | Schaafheim | Hessen | Germany | 64850 |
| 312 | GSK Investigational Site | Vellmar | Hessen | Germany | 34246 |
| 313 | GSK Investigational Site | Damme | Niedersachsen | Germany | 49401 |
| 314 | GSK Investigational Site | Hannover | Niedersachsen | Germany | 30171 |
| 315 | GSK Investigational Site | Hannover | Niedersachsen | Germany | 30177 |
| 316 | GSK Investigational Site | Hildesheim | Niedersachsen | Germany | 31139 |
| 317 | GSK Investigational Site | Lueneburg | Niedersachsen | Germany | 21335 |
| 318 | GSK Investigational Site | Paderborn | Niedersachsen | Germany | 33100 |
| 319 | GSK Investigational Site | Winsen/Lohe | Niedersachsen | Germany | 21423 |
| 320 | GSK Investigational Site | Beckum | Nordrhein-Westfalen | Germany | 59269 |
| 321 | GSK Investigational Site | Bergkamen | Nordrhein-Westfalen | Germany | 59192 |
| 322 | GSK Investigational Site | Borken | Nordrhein-Westfalen | Germany | 46325 |
| 323 | GSK Investigational Site | Dortmund | Nordrhein-Westfalen | Germany | 44137 |
| 324 | GSK Investigational Site | Duisburg | Nordrhein-Westfalen | Germany | 47119 |
| 325 | GSK Investigational Site | Essen | Nordrhein-Westfalen | Germany | 45130 |
| 326 | GSK Investigational Site | Euskirchen | Nordrhein-Westfalen | Germany | 53879 |
| 327 | GSK Investigational Site | Goch | Nordrhein-Westfalen | Germany | 47574 |
| 328 | GSK Investigational Site | Luedenscheid | Nordrhein-Westfalen | Germany | 58511 |
| 329 | GSK Investigational Site | Luenen | Nordrhein-Westfalen | Germany | 44534 |
| 330 | GSK Investigational Site | Neuss | Nordrhein-Westfalen | Germany | 41460 |
| 331 | GSK Investigational Site | Schwabenheim | Nordrhein-Westfalen | Germany | 55270 |
| 332 | GSK Investigational Site | Siegen | Nordrhein-Westfalen | Germany | 57072 |
| 333 | GSK Investigational Site | Warendorf | Nordrhein-Westfalen | Germany | 48231 |
| 334 | GSK Investigational Site | Deidesheim | Rheinland-Pfalz | Germany | 67146 |
| 335 | GSK Investigational Site | Diez | Rheinland-Pfalz | Germany | 65582 |
| 336 | GSK Investigational Site | Lambrecht | Rheinland-Pfalz | Germany | 67466 |
| 337 | GSK Investigational Site | Rhaunen | Rheinland-Pfalz | Germany | 55624 |
| 338 | GSK Investigational Site | Chemnitz | Sachsen | Germany | 09130 |
| 339 | GSK Investigational Site | Dresden | Sachsen | Germany | 01129 |
| 340 | GSK Investigational Site | Dresden | Sachsen | Germany | 01187 |
| 341 | GSK Investigational Site | Dresden | Sachsen | Germany | 01309 |
| 342 | GSK Investigational Site | Freital | Sachsen | Germany | 01705 |
| 343 | GSK Investigational Site | Pirna | Sachsen | Germany | 01796 |
| 344 | GSK Investigational Site | Schmiedeberg | Sachsen | Germany | 01762 |
| 345 | GSK Investigational Site | Itzehoe | Schleswig-Holstein | Germany | 25524 |
| 346 | GSK Investigational Site | Ratzeburg | Schleswig-Holstein | Germany | 23909 |
| 347 | GSK Investigational Site | Wahlstedt | Schleswig-Holstein | Germany | 23812 |
| 348 | GSK Investigational Site | Wilster | Schleswig-Holstein | Germany | 25554 |
| 349 | GSK Investigational Site | Berlin | Germany | 13057 | |
| 350 | GSK Investigational Site | Berlin | Germany | 13355 | |
| 351 | GSK Investigational Site | Hamburg | Germany | 22041 | |
| 352 | GSK Investigational Site | Hamburg | Germany | 22607 | |
| 353 | GSK Investigational Site | Budapest | Hungary | 1076 | |
| 354 | GSK Investigational Site | Miskolc | Hungary | 3526 | |
| 355 | GSK Investigational Site | Belfast | Ireland | BT16 ORH | |
| 356 | GSK Investigational Site | Co. Tipperary | Ireland | ||
| 357 | GSK Investigational Site | Cork | Ireland | ||
| 358 | GSK Investigational Site | Dublin | Ireland | 15 | |
| 359 | GSK Investigational Site | Dublin | Ireland | 24 | |
| 360 | GSK Investigational Site | Dublin | Ireland | 4 | |
| 361 | GSK Investigational Site | Dublin | Ireland | 7 | |
| 362 | GSK Investigational Site | Dublin | Ireland | 8 | |
| 363 | GSK Investigational Site | Gowran | Ireland | ||
| 364 | GSK Investigational Site | Kilkenny | Ireland | ||
| 365 | GSK Investigational Site | Ferrara | Emilia-Romagna | Italy | 44100 |
| 366 | GSK Investigational Site | Ravenna | Emilia-Romagna | Italy | 48100 |
| 367 | GSK Investigational Site | Scandiano (RE) | Emilia-Romagna | Italy | 42019 |
| 368 | GSK Investigational Site | Rozzano (MI) | Lombardia | Italy | 20089 |
| 369 | GSK Investigational Site | Acquaviva Delle Fonti (BA) | Puglia | Italy | 70021 |
| 370 | GSK Investigational Site | Catania | Sicilia | Italy | 95100 |
| 371 | GSK Investigational Site | Città Di Castello (PG) | Umbria | Italy | 06012 |
| 372 | GSK Investigational Site | Firenze | Italy | 50134 | |
| 373 | GSK Investigational Site | La Spezia | Italy | 19100 | |
| 374 | GSK Investigational Site | Lecce | Italy | 73100 | |
| 375 | GSK Investigational Site | Milano | Italy | 20132 | |
| 376 | GSK Investigational Site | Palermo | Italy | 90127 | |
| 377 | GSK Investigational Site | Parma | Italy | 43100 | |
| 378 | GSK Investigational Site | Perugia | Italy | 06126 | |
| 379 | GSK Investigational Site | Rovigo | Italy | 45100 | |
| 380 | GSK Investigational Site | S. Benedetto TR (AP) | Italy | ||
| 381 | GSK Investigational Site | San Giovanni Rotondo FG | Italy | ||
| 382 | GSK Investigational Site | Sassari | Italy | ||
| 383 | GSK Investigational Site | Terni | Italy | 05100 | |
| 384 | GSK Investigational Site | Torino | Italy | 10126 | |
| 385 | GSK Investigational Site | Udine | Italy | 33100 | |
| 386 | GSK Investigational Site | Vicenza | Italy | 36100 | |
| 387 | GSK Investigational Site | De Bilt | Netherlands | 3731 DN | |
| 388 | GSK Investigational Site | Den Bosch | Netherlands | 5223 GV | |
| 389 | GSK Investigational Site | Geleen | Netherlands | 6166 GR | |
| 390 | GSK Investigational Site | Hengelo | Netherlands | 7555 DL | |
| 391 | GSK Investigational Site | Huizen | Netherlands | 1271 BB | |
| 392 | GSK Investigational Site | Losser | Netherlands | 7581 BV | |
| 393 | GSK Investigational Site | Losser | Netherlands | 7582 BD | |
| 394 | GSK Investigational Site | Rijswijk | Netherlands | 2281 AK | |
| 395 | GSK Investigational Site | Roelofarendsveen | Netherlands | 2371 RB | |
| 396 | GSK Investigational Site | Woerden | Netherlands | 3443 GG | |
| 397 | GSK Investigational Site | Hamar | Norway | 2317 | |
| 398 | GSK Investigational Site | Paradis | Norway | 5231 | |
| 399 | GSK Investigational Site | Skedsmokorset | Norway | N-2020 | |
| 400 | GSK Investigational Site | Albaida (Valencia) | Spain | ||
| 401 | GSK Investigational Site | Basurto/Bilbao | Spain | 48013 | |
| 402 | GSK Investigational Site | Benassal (Castellón) | Spain | 12160 | |
| 403 | GSK Investigational Site | Benicasim (Castellón) | Spain | ||
| 404 | GSK Investigational Site | Bilbao | Spain | 48013 | |
| 405 | GSK Investigational Site | Cartagena | Spain | 30203 | |
| 406 | GSK Investigational Site | Cáceres | Spain | 10005 | |
| 407 | GSK Investigational Site | El Palmar (Murcia) | Spain | 30120 | |
| 408 | GSK Investigational Site | Elche (Alicante) | Spain | 03202 | |
| 409 | GSK Investigational Site | Elda-Alicante | Spain | 03600 | |
| 410 | GSK Investigational Site | Figueras | Spain | 17600 | |
| 411 | GSK Investigational Site | Gerona | Spain | ||
| 412 | GSK Investigational Site | Granollers (Barcelona) | Spain | 08400 | |
| 413 | GSK Investigational Site | Jerez (Cadiz) | Spain | 11047 | |
| 414 | GSK Investigational Site | Madrid | Spain | 28006 | |
| 415 | GSK Investigational Site | Madrid | Spain | 28046 | |
| 416 | GSK Investigational Site | Malaga | Spain | 29009 | |
| 417 | GSK Investigational Site | Mataro | Spain | 08034 | |
| 418 | GSK Investigational Site | Merida | Spain | 6800 | |
| 419 | GSK Investigational Site | Olleria, Valencia | Spain | 46850 | |
| 420 | GSK Investigational Site | Onda/Castellón | Spain | 12200 | |
| 421 | GSK Investigational Site | Orihuela (Alicante) | Spain | 03314 | |
| 422 | GSK Investigational Site | Plasencia | Spain | 10600 | |
| 423 | GSK Investigational Site | Pontevedra | Spain | 36071 | |
| 424 | GSK Investigational Site | Sagunto/Valencia | Spain | 46520 | |
| 425 | GSK Investigational Site | San Juan (Alicante) | Spain | 03550 | |
| 426 | GSK Investigational Site | San Vincente Raspeig (Alicante) | Spain | 03690 | |
| 427 | GSK Investigational Site | Santa Coloma De Gramanet (Barcelona) | Spain | 08923 | |
| 428 | GSK Investigational Site | Tenerife | Spain | 38010 | |
| 429 | GSK Investigational Site | Tereul | Spain | 44002 | |
| 430 | GSK Investigational Site | Toledo | Spain | 45004 | |
| 431 | GSK Investigational Site | Torrelavega/Santander | Spain | 39300 | |
| 432 | GSK Investigational Site | Valencia | Spain | 46017 | |
| 433 | GSK Investigational Site | Valencia | Spain | 46830 | |
| 434 | GSK Investigational Site | Valencia | Spain | ||
| 435 | GSK Investigational Site | Valladolid | Spain | 47010 | |
| 436 | GSK Investigational Site | Vallda (Valencia) | Spain | ||
| 437 | GSK Investigational Site | Villajoyosa - Alicante | Spain | 03570 | |
| 438 | GSK Investigational Site | Zamora | Spain | 49021 | |
| 439 | GSK Investigational Site | Zaragoza | Spain | 50003 | |
| 440 | GSK Investigational Site | Alta | Sweden | 138 21 | |
| 441 | GSK Investigational Site | Degerberga | Sweden | 297 31 | |
| 442 | GSK Investigational Site | Gimo | Sweden | SE-747 43 | |
| 443 | GSK Investigational Site | Malmö | Sweden | SE-214 26 | |
| 444 | GSK Investigational Site | Stockholm | Sweden | SE-114 35 | |
| 445 | GSK Investigational Site | Aberdeen | Aberdeenshire | United Kingdom | AB25 2AY |
| 446 | GSK Investigational Site | Sandy | Bedfordshire | United Kingdom | SG19 3JR |
| 447 | GSK Investigational Site | Reading | Berkshire | United Kingdom | RG2 7AG |
| 448 | GSK Investigational Site | Llanelli | Carmarthenshire | United Kingdom | SA14 8QF |
| 449 | GSK Investigational Site | Warrington | Cheshire | United Kingdom | WA5 1QC |
| 450 | GSK Investigational Site | Bournemouth | Dorset | United Kingdom | BH7 7DW |
| 451 | GSK Investigational Site | Poole | Dorset | United Kingdom | |
| 452 | GSK Investigational Site | Barry | Glamorgan | United Kingdom | CF63 4HP |
| 453 | GSK Investigational Site | Cardiff | Glamorgan | United Kingdom | CF14 9BB |
| 454 | GSK Investigational Site | Hemel Hempstead | Hertfordshire | United Kingdom | HP2 4AD |
| 455 | GSK Investigational Site | Stevenage | Hertfordshire | United Kingdom | |
| 456 | GSK Investigational Site | Airdrie | Lanarkshire | United Kingdom | ML6 0JS |
| 457 | GSK Investigational Site | Glasgow | Lanarkshire | United Kingdom | G81 4SA |
| 458 | GSK Investigational Site | Bolton | Lancashire | United Kingdom | |
| 459 | GSK Investigational Site | Chorley | Lancashire | United Kingdom | PR7 1NY |
| 460 | GSK Investigational Site | Edinburgh | Midlothian | United Kingdom | EH3 9YW |
| 461 | GSK Investigational Site | Wellingborough | Northamptonshire | United Kingdom | NN8 4RW |
| 462 | GSK Investigational Site | Nottingham | Nottinghamshire | United Kingdom | NG3 7DQ |
| 463 | GSK Investigational Site | Haverfordwest | Pembrokeshire | United Kingdom | SA61 1RN |
| 464 | GSK Investigational Site | Frome | Somerset | United Kingdom | BA11 1EZ |
| 465 | GSK Investigational Site | Crawley | Sussex West | United Kingdom | RH10 1LL |
| 466 | GSK Investigational Site | Nuneaton | Warwickshire | United Kingdom | CV10 7DJ |
| 467 | GSK Investigational Site | Rugby | Warwickshire | United Kingdom | CV21 3SP |
| 468 | GSK Investigational Site | Livingston | West Lothian | United Kingdom | EH54 6PP |
| 469 | GSK Investigational Site | Melksham | Wiltshire | United Kingdom | SN12 6UN |
| 470 | GSK Investigational Site | Trowbridge | Wiltshire | United Kingdom | BA14 8TG |
| 471 | GSK Investigational Site | Barnsley | United Kingdom | S70 3RJ | |
| 472 | GSK Investigational Site | Bath | United Kingdom | BA2 3HT | |
| 473 | GSK Investigational Site | Bradford | United Kingdom | BD7 3EE | |
| 474 | GSK Investigational Site | Cardiff | United Kingdom | CF5 4AE | |
| 475 | GSK Investigational Site | Co.Antrim | United Kingdom | ||
| 476 | GSK Investigational Site | Doncaster | United Kingdom | DN1 2EG | |
| 477 | GSK Investigational Site | Doncaster | United Kingdom | DN9 1EP | |
| 478 | GSK Investigational Site | Gateshead | United Kingdom | NE9 6SX | |
| 479 | GSK Investigational Site | Glasgow | United Kingdom | G51 4TF | |
| 480 | GSK Investigational Site | Glenrothes | United Kingdom | ||
| 481 | GSK Investigational Site | Irvine | United Kingdom | KA12 OAY | |
| 482 | GSK Investigational Site | Kent | United Kingdom | TN11 9HL | |
| 483 | GSK Investigational Site | Leicester | United Kingdom | LE3 8GS | |
| 484 | GSK Investigational Site | London | United Kingdom | SE1 9RT | |
| 485 | GSK Investigational Site | London | United Kingdom | W1M 7AB | |
| 486 | GSK Investigational Site | Newtownabbey | United Kingdom | BT36 4PP | |
| 487 | GSK Investigational Site | Peterborough | United Kingdom | PE7 3JL | |
| 488 | GSK Investigational Site | Swansea | United Kingdom | SA4 4BY | |
| 489 | GSK Investigational Site | Wakefield | United Kingdom | WF1 4DG | |
| 490 | GSK Investigational Site | Wigan | United Kingdom | WN1 1XX |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00279045
Other Study ID Numbers:
- 49653/048
First Posted:
Jan 19, 2006
Last Update Posted:
Nov 29, 2017
Last Verified:
Nov 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms: