BOREALIS-AF: Evaluation of Weekly Idrabiotaparinux Sodium Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation
Sponsor
Sanofi (Industry)
Overall Status
Terminated
CT.gov ID
NCT00580216
Collaborator
(none)
3,773
538
2
34
7
0.2
Study Details
Study Description
Brief Summary
The objective is to evaluate whether once weekly subcutaneous (SC) injection of idrabiotaparinux sodium (biotinylated idraparinux) is at least as efficient to prevent clots in brain and in the other organs than oral international normalized ratio (INR) adjusted-dose warfarin in patients with atrial fibrillation (AF).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
The end of the study is defined by a common study end date for all participants, defined as 9 months (39 weeks) after the last participant randomized.
All participants will receive oral warfarin (or matching placebo) and weekly SC injections of idrabiotaparinux sodium (or matching placebo) up to 6 months before the common study end date. All participants are expected to be treated for at least 6 months.
All participants will have then an 6-month observational period after cessation of study treatment.
Study Design
Study Type:
Interventional
Actual Enrollment
:
3773 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Multicenter, Randomized, Double-blind, Assessor-blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous Biotinylated Idraparinux (SSR126517E) With Oral Adjusted-dose Warfarin in the Prevention of Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation
Study Start Date
:
Dec 1, 2007
Actual Primary Completion Date
:
Oct 1, 2010
Actual Study Completion Date
:
Oct 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Idrabiotaparinux Idrabiotaparinux sodium, 3.0 mg, once-weekly for 7 weeks followed a maintenance dosing adjusted according to the age and to the renal function for a minimum total treatment duration of 6 months. Avidin, 100 mg, at the discretion of the investigator whenever deemed appropriate and possible (ie, life-threatening bleeding, emergency invasive procedure with the potential of uncontrolled bleeding, or overdosage). |
Drug: Idrabiotaparinux sodium
Pre-filled syringes containing:
0.5 mL for the 3.0 mg dosage;
0.33 mL for the 2.0 mg dosage (maintenance dosage for participants with mild renal impairment and less than 75 years old);
0.25 mL for the 1.5 mg dosage (maintenance dosage for participants with moderate renal impairment or age ≥75 years).
Subcutaneous injection
Other Names:
Drug: Placebo (for warfarin)
Warfarin matching capsules
Oral administration
Drug: Avidin
Vial containing 105 mg of lyophilized powder for dilution
Intravenous infusion for 30 minutes
Other Names:
|
| Active Comparator: Warfarin Warfarin, INR-adjusted dose, for a minimum total treatment duration of 6 months. |
Drug: Warfarin
Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month)
Oral administration
Drug: Placebo (for idrabiotaparinux)
Matching pre-filled syringes containing:
0.5 mL for the 3.0 mg dosage;
0.33 mL for the 2.0 mg dosage (maintenance dosage for participants with mild renal impairment and less than 75 years old);
0.25 mL for the 1.5 mg dosage (maintenance dosage for participants with moderate renal impairment or age ≥75 years).
Subcutaneous injection
Drug: Placebo (for avidin)
Vial containing 105 mg of matching lyophilized powder for dissolution
Intravenous infusion for 30 minutes
|
Outcome Measures
Primary Outcome Measures
- Composite of all fatal or non-fatal strokes or non central nervous system (CNS) systemic embolic events (SE) [From randomization up to the end of the treatment period (minimum of 6 months)]
Secondary Outcome Measures
- Components of the primary study outcome measure: [From randomization up to the end of the treatment period (minimum of 6 months)]
- Composite of stroke or non CNS SE or myocardial infarction (MI) or venous thromboembolism (VTE) or major bleeding or death [From randomization up to the end of the treatment period (minimum of 6 months)]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Non valvular atrial fibrillation (AF)
-
Indication for long-term Vitamin-K antagonist (VKA) therapy based on the presence of previous ischemic stroke, transient ischemic attack (TIA) or systemic embolism and/or at least two of the following risk factors: hypertension requiring drug treatment, moderately or severely impaired left ventricular function and/or congestive heart failure, age > or = 75 years, diabetes mellitus.
Main exclusion Criteria:
-
Indication for VKA other than AF
-
Stroke or TIA within previous 5 days
-
Transient AF caused by a reversible disorder
-
Planned major surgery/trauma or cardioversion within 30 days
-
INR > 3 at baseline
-
Active bleeding or high risk of bleeding
-
Uncontrolled hypertension
-
Pregnancy or childbearing potential without proper contraceptive measures or breast feeding.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-Aventis Investigational Site Number 840227 | Mobile | Alabama | United States | 36608 |
| 2 | Sanofi-Aventis Investigational Site Number 840209 | Tucson | Arizona | United States | 85723 |
| 3 | Sanofi-Aventis Investigational Site Number 840255 | Little Rock | Arkansas | United States | 72204 |
| 4 | Sanofi-Aventis Investigational Site Number 840224 | Little Rock | Arkansas | United States | 72205 |
| 5 | Sanofi-Aventis Investigational Site Number 840179 | Mountain Home | Arkansas | United States | 72653 |
| 6 | Sanofi-Aventis Investigational Site Number 840270 | Beverly Hills | California | United States | 90210 |
| 7 | Sanofi-Aventis Investigational Site Number 840278 | Beverly Hills | California | United States | 90211 |
| 8 | Sanofi-Aventis Investigational Site Number 840241 | Burbank | California | United States | 91505 |
| 9 | Sanofi-Aventis Investigational Site Number 840010 | Corona | California | United States | 92879 |
| 10 | Sanofi-Aventis Investigational Site Number 840195 | Encino | California | United States | 91436 |
| 11 | Sanofi-Aventis Investigational Site Number 840033 | Loma Linda | California | United States | 92354 |
| 12 | Sanofi-Aventis Investigational Site Number 840184 | Long Beach | California | United States | 90813 |
| 13 | Sanofi-Aventis Investigational Site Number 840183 | Los Banos | California | United States | 93635 |
| 14 | Sanofi-Aventis Investigational Site Number 840272 | Northridge | California | United States | 91325 |
| 15 | Sanofi-Aventis Investigational Site Number 840213 | Orange | California | United States | 92868 |
| 16 | Sanofi-Aventis Investigational Site Number 840009 | Redondo Beach | California | United States | 90277 |
| 17 | Sanofi-Aventis Investigational Site Number 840298 | Riverside | California | United States | 92501 |
| 18 | Sanofi-Aventis Investigational Site Number 840264 | San Diego | California | United States | 92103 |
| 19 | Sanofi-Aventis Investigational Site Number 840275 | San Diego | California | United States | 92128 |
| 20 | Sanofi-Aventis Investigational Site Number 840103 | Santa Ana | California | United States | 92704 |
| 21 | Sanofi-Aventis Investigational Site Number 840002 | Santa Rosa | California | United States | 95405 |
| 22 | Sanofi-Aventis Investigational Site Number 840111 | Torrance | California | United States | 90505 |
| 23 | Sanofi-Aventis Investigational Site Number 840118 | Visalia | California | United States | 93291 |
| 24 | Sanofi-Aventis Investigational Site Number 840268 | Bridgeport | Connecticut | United States | 06610 |
| 25 | Sanofi-Aventis Investigational Site Number 840246 | Bay Pines | Florida | United States | 33744 |
| 26 | Sanofi-Aventis Investigational Site Number 840066 | Beach | Florida | United States | 32168 |
| 27 | Sanofi-Aventis Investigational Site Number 840313 | Brandon | Florida | United States | 33511 |
| 28 | Sanofi-Aventis Investigational Site Number 840084 | Dunnellon | Florida | United States | 34432 |
| 29 | Sanofi-Aventis Investigational Site Number 840220 | Fort Lauderdale | Florida | United States | 33316 |
| 30 | Sanofi-Aventis Investigational Site Number 840138 | Ft. Lauderdale | Florida | United States | 33308 |
| 31 | Sanofi-Aventis Investigational Site Number 840215 | Gainesville | Florida | United States | 32608 |
| 32 | Sanofi-Aventis Investigational Site Number 840131 | Hollywood | Florida | United States | 33021 |
| 33 | Sanofi-Aventis Investigational Site Number 840161 | Hollywood | Florida | United States | 33021 |
| 34 | Sanofi-Aventis Investigational Site Number 840234 | Key West | Florida | United States | 33040 |
| 35 | Sanofi-Aventis Investigational Site Number 840112 | Lake Mary | Florida | United States | 32746 |
| 36 | Sanofi-Aventis Investigational Site Number 840053 | Lakeland | Florida | United States | 33805 |
| 37 | Sanofi-Aventis Investigational Site Number 840198 | Melbourne | Florida | United States | 32901 |
| 38 | Sanofi-Aventis Investigational Site Number 840117 | Miami | Florida | United States | 33156 |
| 39 | Sanofi-Aventis Investigational Site Number 840003 | Niceville | Florida | United States | 32578 |
| 40 | Sanofi-Aventis Investigational Site Number 840230 | Ocala | Florida | United States | 34471 |
| 41 | Sanofi-Aventis Investigational Site Number 840202 | Orlando | Florida | United States | 32803 |
| 42 | Sanofi-Aventis Investigational Site Number 840306 | Orlando | Florida | United States | 32822 |
| 43 | Sanofi-Aventis Investigational Site Number 840022 | Ormond Beach | Florida | United States | 32174 |
| 44 | Sanofi-Aventis Investigational Site Number 840110 | Palm Harbor | Florida | United States | 34684 |
| 45 | Sanofi-Aventis Investigational Site Number 840211 | Plantation | Florida | United States | 33317 |
| 46 | Sanofi-Aventis Investigational Site Number 840116 | Sanford | Florida | United States | 32271 |
| 47 | Sanofi-Aventis Investigational Site Number 840243 | Spring Hill | Florida | United States | 34609 |
| 48 | Sanofi-Aventis Investigational Site Number 840082 | St. Petersburg | Florida | United States | 33701 |
| 49 | Sanofi-Aventis Investigational Site Number 840012 | St. Petersburg | Florida | United States | 33707 |
| 50 | Sanofi-Aventis Investigational Site Number 840073 | Atlanta | Georgia | United States | 30342 |
| 51 | Sanofi-Aventis Investigational Site Number 840273 | Augusta | Georgia | United States | 30909 |
| 52 | Sanofi-Aventis Investigational Site Number 840204 | Columbus | Georgia | United States | 31904-5245 |
| 53 | Sanofi-Aventis Investigational Site Number 840290 | Columbus | Georgia | United States | 31904 |
| 54 | Sanofi-Aventis Investigational Site Number 840225 | Columbus | Georgia | United States | 31907 |
| 55 | Sanofi-Aventis Investigational Site Number 840305 | Dunwoody | Georgia | United States | 30338 |
| 56 | Sanofi-Aventis Investigational Site Number 840165 | Savannah | Georgia | United States | 31405 |
| 57 | Sanofi-Aventis Investigational Site Number 840130 | Idaho Falls | Idaho | United States | 83404 |
| 58 | Sanofi-Aventis Investigational Site Number 840228 | Idaho Falls | Idaho | United States | 83404 |
| 59 | Sanofi-Aventis Investigational Site Number 840143 | Nampa | Idaho | United States | 83686 |
| 60 | Sanofi-Aventis Investigational Site Number 840221 | Chicago | Illinois | United States | 60637 |
| 61 | Sanofi-Aventis Investigational Site Number 840206 | Chicago | Illinois | United States | 60664 |
| 62 | Sanofi-Aventis Investigational Site Number 840280 | Beaver | Indiana | United States | 15009 |
| 63 | Sanofi-Aventis Investigational Site Number 840014 | Elkhart | Indiana | United States | 46514 |
| 64 | Sanofi-Aventis Investigational Site Number 840249 | Wichita | Kansas | United States | 67208 |
| 65 | Sanofi-Aventis Investigational Site Number 840265 | Lexington | Kentucky | United States | 40504 |
| 66 | Sanofi-Aventis Investigational Site Number 840047 | Alexandria | Louisiana | United States | SUITE 250 |
| 67 | Sanofi-Aventis Investigational Site Number 840218 | Jena | Louisiana | United States | 71342 |
| 68 | Sanofi-Aventis Investigational Site Number 840247 | Lafayette | Louisiana | United States | 70503 |
| 69 | Sanofi-Aventis Investigational Site Number 840158 | Lake Charles | Louisiana | United States | 70601 |
| 70 | Sanofi-Aventis Investigational Site Number 840077 | Natchitoches | Louisiana | United States | 71457 |
| 71 | Sanofi-Aventis Investigational Site Number 840259 | Shreveport | Louisiana | United States | 71103 |
| 72 | Sanofi-Aventis Investigational Site Number 840231 | Shreveport | Louisiana | United States | 71105 |
| 73 | Sanofi-Aventis Investigational Site Number 840232 | Shreveport | Louisiana | United States | 71105 |
| 74 | Sanofi-Aventis Investigational Site Number 840145 | Auburn | Maine | United States | 04210 |
| 75 | Sanofi-Aventis Investigational Site Number 840017 | Baltimore | Maryland | United States | 21237 |
| 76 | Sanofi-Aventis Investigational Site Number 840317 | Denton | Maryland | United States | 76201 |
| 77 | Sanofi-Aventis Investigational Site Number 840311 | Alpena | Michigan | United States | 49707 |
| 78 | Sanofi-Aventis Investigational Site Number 840276 | Brighton | Michigan | United States | 48114 |
| 79 | Sanofi-Aventis Investigational Site Number 840242 | Detroit | Michigan | United States | 48236 |
| 80 | Sanofi-Aventis Investigational Site Number 840253 | Grand Rapids | Michigan | United States | 49503 |
| 81 | Sanofi-Aventis Investigational Site Number 840137 | St. Clair Shores | Michigan | United States | 48081 |
| 82 | Sanofi-Aventis Investigational Site Number 840134 | St Cloud | Minnesota | United States | 56303 |
| 83 | Sanofi-Aventis Investigational Site Number 840067 | Gulfport | Mississippi | United States | 39503 |
| 84 | Sanofi-Aventis Investigational Site Number 840006 | Picayune | Mississippi | United States | 39466 |
| 85 | Sanofi-Aventis Investigational Site Number 840201 | St Louis | Missouri | United States | 63104 |
| 86 | Sanofi-Aventis Investigational Site Number 840310 | St. Louis | Missouri | United States | 63122 |
| 87 | Sanofi-Aventis Investigational Site Number 840200 | St. Louis | Missouri | United States | 63128 |
| 88 | Sanofi-Aventis Investigational Site Number 840323 | St. Louis | Missouri | United States | 63141 |
| 89 | Sanofi-Aventis Investigational Site Number 840096 | Anaconda | Montana | United States | 59711 |
| 90 | Sanofi-Aventis Investigational Site Number 840008 | Butte | Montana | United States | 59701 |
| 91 | Sanofi-Aventis Investigational Site Number 840126 | Fremont | Nebraska | United States | 68025 |
| 92 | Sanofi-Aventis Investigational Site Number 840051 | Las Vegas | Nevada | United States | 89119 |
| 93 | Sanofi-Aventis Investigational Site Number 840258 | Las Vegas | Nevada | United States | 89144 |
| 94 | Sanofi-Aventis Investigational Site Number 840303 | Hamilton | New Jersey | United States | 08690 |
| 95 | Sanofi-Aventis Investigational Site Number 840109 | Linden | New Jersey | United States | 07036 |
| 96 | Sanofi-Aventis Investigational Site Number 840024 | Morristown | New Jersey | United States | 07962-1956 |
| 97 | Sanofi-Aventis Investigational Site Number 840284 | Bronx | New York | United States | |
| 98 | Sanofi-Aventis Investigational Site Number 840102 | Buffalo | New York | United States | 14209 |
| 99 | Sanofi-Aventis Investigational Site Number 840152 | Johnson City | New York | United States | 13790 |
| 100 | Sanofi-Aventis Investigational Site Number 840159 | Rochester | New York | United States | 14607 |
| 101 | Sanofi-Aventis Investigational Site Number 840056 | Westfield | New York | United States | 14787 |
| 102 | Sanofi-Aventis Investigational Site Number 840277 | Greensboro | North Carolina | United States | 27401 |
| 103 | Sanofi-Aventis Investigational Site Number 840196 | Greensboro | North Carolina | United States | 27408 |
| 104 | Sanofi-Aventis Investigational Site Number 840127 | Hickory | North Carolina | United States | 28602 |
| 105 | Sanofi-Aventis Investigational Site Number 840150 | Raleigh | North Carolina | United States | 27615 |
| 106 | Sanofi-Aventis Investigational Site Number 840185 | Rocky Mount | North Carolina | United States | 27804 |
| 107 | Sanofi-Aventis Investigational Site Number 840020 | Fargo | North Dakota | United States | 58103 |
| 108 | Sanofi-Aventis Investigational Site Number 840197 | Centerville | Ohio | United States | 45459 |
| 109 | Sanofi-Aventis Investigational Site Number 840074 | Cincinnati | Ohio | United States | 45267-0525 |
| 110 | Sanofi-Aventis Investigational Site Number 840146 | Cleveland | Ohio | United States | 44109 |
| 111 | Sanofi-Aventis Investigational Site Number 840292 | Gallipolis | Ohio | United States | 45631 |
| 112 | Sanofi-Aventis Investigational Site Number 840026 | Mason | Ohio | United States | 45040 |
| 113 | Sanofi-Aventis Investigational Site Number 840233 | Toledo | Ohio | United States | 43608 |
| 114 | Sanofi-Aventis Investigational Site Number 840064 | Wadsworth | Ohio | United States | 44281 |
| 115 | Sanofi-Aventis Investigational Site Number 840045 | Oklahoma City | Oklahoma | United States | 73104 |
| 116 | Sanofi-Aventis Investigational Site Number 840133 | Tulsa | Oklahoma | United States | 74104 |
| 117 | Sanofi-Aventis Investigational Site Number 840113 | Bend | Oregon | United States | 97701 |
| 118 | Sanofi-Aventis Investigational Site Number 840257 | Portland | Oregon | United States | 97220 |
| 119 | Sanofi-Aventis Investigational Site Number 840304 | Indiana | Pennsylvania | United States | 15701 |
| 120 | Sanofi-Aventis Investigational Site Number 840128 | Philadelphia | Pennsylvania | United States | 19102 |
| 121 | Sanofi-Aventis Investigational Site Number 840160 | Philadelphia | Pennsylvania | United States | 19143 |
| 122 | Sanofi-Aventis Investigational Site Number 840339 | Philadelphia | Pennsylvania | United States | 19149 |
| 123 | Sanofi-Aventis Investigational Site Number 840181 | Pittsburgh | Pennsylvania | United States | 15240 |
| 124 | Sanofi-Aventis Investigational Site Number 840229 | Scotland | Pennsylvania | United States | 17254 |
| 125 | Sanofi-Aventis Investigational Site Number 840072 | Stoneboro | Pennsylvania | United States | 16153 |
| 126 | Sanofi-Aventis Investigational Site Number 840248 | Cranston | Rhode Island | United States | 02920 |
| 127 | Sanofi-Aventis Investigational Site Number 840261 | Anderson | South Carolina | United States | 29621 |
| 128 | Sanofi-Aventis Investigational Site Number 840297 | Anderson | South Carolina | United States | 29621 |
| 129 | Sanofi-Aventis Investigational Site Number 840172 | Camden | South Carolina | United States | 29020 |
| 130 | Sanofi-Aventis Investigational Site Number 840168 | Columbia | South Carolina | United States | 29201 |
| 131 | Sanofi-Aventis Investigational Site Number 840122 | Manning | South Carolina | United States | 29102 |
| 132 | Sanofi-Aventis Investigational Site Number 840085 | Newberry | South Carolina | United States | 29108 |
| 133 | Sanofi-Aventis Investigational Site Number 840189 | Pelzer | South Carolina | United States | 29669 |
| 134 | Sanofi-Aventis Investigational Site Number 840032 | Fort Meade | South Dakota | United States | 57741 |
| 135 | Sanofi-Aventis Investigational Site Number 840062 | Athens | Tennessee | United States | 37303 |
| 136 | Sanofi-Aventis Investigational Site Number 840048 | Bristol | Tennessee | United States | 37620 |
| 137 | Sanofi-Aventis Investigational Site Number 840052 | Bristol | Tennessee | United States | 37620 |
| 138 | Sanofi-Aventis Investigational Site Number 840104 | Cleveland | Tennessee | United States | 37312 |
| 139 | Sanofi-Aventis Investigational Site Number 840129 | Johnson City | Tennessee | United States | 37614 |
| 140 | Sanofi-Aventis Investigational Site Number 840269 | Nashville | Tennessee | United States | 37203 |
| 141 | Sanofi-Aventis Investigational Site Number 840076 | Amarillo | Texas | United States | 79106 |
| 142 | Sanofi-Aventis Investigational Site Number 840252 | Corsicana | Texas | United States | 75110 |
| 143 | Sanofi-Aventis Investigational Site Number 840286 | Houston | Texas | United States | 77070 |
| 144 | Sanofi-Aventis Investigational Site Number 840132 | Irving | Texas | United States | 75061 |
| 145 | Sanofi-Aventis Investigational Site Number 840005 | Odessa | Texas | United States | 79761 |
| 146 | Sanofi-Aventis Investigational Site Number 840289 | Odessa | Texas | United States | 79761 |
| 147 | Sanofi-Aventis Investigational Site Number 840186 | San Antonio | Texas | United States | 78234 |
| 148 | Sanofi-Aventis Investigational Site Number 840194 | San Antonio | Texas | United States | 78238 |
| 149 | Sanofi-Aventis Investigational Site Number 840236 | Temple | Texas | United States | 76508 |
| 150 | Sanofi-Aventis Investigational Site Number 840011 | Victoria | Texas | United States | 77901 |
| 151 | Sanofi-Aventis Investigational Site Number 840285 | Wichita Falls | Texas | United States | 76309 |
| 152 | Sanofi-Aventis Investigational Site Number 840223 | Clinton | Utah | United States | 84015 |
| 153 | Sanofi-Aventis Investigational Site Number 840238 | Salt Lake City | Utah | United States | 84124 |
| 154 | Sanofi-Aventis Investigational Site Number 840308 | Salt Lake City | Utah | United States | 84124 |
| 155 | Sanofi-Aventis Investigational Site Number 840068 | Salem | Virginia | United States | 24153 |
| 156 | Sanofi-Aventis Investigational Site Number 840219 | Springfield | Virginia | United States | 22151 |
| 157 | Sanofi-Aventis Investigational Site Number 840058 | Everett | Washington | United States | 98201 |
| 158 | Sanofi-Aventis Investigational Site Number 840123 | Seattle | Washington | United States | 98111 |
| 159 | Sanofi-Aventis Investigational Site Number 840019 | Tacoma | Washington | United States | 98405 |
| 160 | Sanofi-Aventis Investigational Site Number 840256 | Beloit | Wisconsin | United States | 53511 |
| 161 | Sanofi-Aventis Investigational Site Number 840293 | Madison | Wisconsin | United States | 53713 |
| 162 | Sanofi-Aventis Investigational Site Number 840282 | Wauwatosa | Wisconsin | United States | 53226 |
| 163 | Sanofi-Aventis Investigational Site Number 032007 | Buenos Aires | Argentina | 1221 | |
| 164 | Sanofi-Aventis Investigational Site Number 032011 | Buenos Aires | Argentina | 1416 | |
| 165 | Sanofi-Aventis Investigational Site Number 032001 | Buenos Aires | Argentina | C1428AQK | |
| 166 | Sanofi-Aventis Investigational Site Number 032005 | Buenos Aires | Argentina | C1437JCP | |
| 167 | Sanofi-Aventis Investigational Site Number 032009 | Capital Federal | Argentina | C1094AAD | |
| 168 | Sanofi-Aventis Investigational Site Number 032012 | Corrientes | Argentina | 3400 | |
| 169 | Sanofi-Aventis Investigational Site Number 032006 | Mar Del Plata | Argentina | 7600 | |
| 170 | Sanofi-Aventis Investigational Site Number 032014 | Moron | Argentina | ||
| 171 | Sanofi-Aventis Investigational Site Number 032016 | Salta | Argentina | 4400 | |
| 172 | Sanofi-Aventis Investigational Site Number 032010 | Zarate | Argentina | 2800 | |
| 173 | Sanofi-Aventis Investigational Site Number 036006 | Adelaide | Australia | 5035 | |
| 174 | Sanofi-Aventis Investigational Site Number 036003 | Auchenflower | Australia | 4066 | |
| 175 | Sanofi-Aventis Investigational Site Number 036008 | Box Hill | Australia | 3128 | |
| 176 | Sanofi-Aventis Investigational Site Number 036005 | Coffs Harbour | Australia | 2450 | |
| 177 | Sanofi-Aventis Investigational Site Number 036001 | Kippa Ring | Australia | 4021 | |
| 178 | Sanofi-Aventis Investigational Site Number 036002 | Kippa Ring | Australia | 4021 | |
| 179 | Sanofi-Aventis Investigational Site Number 036009 | Launceston | Australia | 7250 | |
| 180 | Sanofi-Aventis Investigational Site Number 036010 | Woden | Australia | 2606 | |
| 181 | Sanofi-Aventis Investigational Site Number 040001 | Graz | Austria | 8036 | |
| 182 | Sanofi-Aventis Investigational Site Number 040004 | Linz | Austria | 4021 | |
| 183 | Sanofi-Aventis Investigational Site Number 112001 | Minsk | Belarus | 220013 | |
| 184 | Sanofi-Aventis Investigational Site Number 112002 | Minsk | Belarus | 220116 | |
| 185 | Sanofi-Aventis Investigational Site Number 112003 | Minsk | Belarus | 220116 | |
| 186 | Sanofi-Aventis Investigational Site Number 112005 | Minsk | Belarus | 220600 | |
| 187 | Sanofi-Aventis Investigational Site Number 076019 | Belo Horizonte | Brazil | 30150-221 | |
| 188 | Sanofi-Aventis Investigational Site Number 076011 | Campina Grande Do Sul | Brazil | 83430-000 | |
| 189 | Sanofi-Aventis Investigational Site Number 076007 | Campinas | Brazil | 13059-740 | |
| 190 | Sanofi-Aventis Investigational Site Number 076013 | Campinas | Brazil | 13083-190 | |
| 191 | Sanofi-Aventis Investigational Site Number 076001 | Curitiba | Brazil | 80730-150 | |
| 192 | Sanofi-Aventis Investigational Site Number 076017 | Goiania | Brazil | 74223-130 | |
| 193 | Sanofi-Aventis Investigational Site Number 076016 | Goiania | Brazil | 74605-020 | |
| 194 | Sanofi-Aventis Investigational Site Number 076018 | Maceio | Brazil | 57021-500 | |
| 195 | Sanofi-Aventis Investigational Site Number 076012 | Porto Alegre | Brazil | 90610-000 | |
| 196 | Sanofi-Aventis Investigational Site Number 076008 | Porto Alegre | Brazil | 90810-120 | |
| 197 | Sanofi-Aventis Investigational Site Number 076014 | Porto Alegre | Brazil | 91350 200 | |
| 198 | Sanofi-Aventis Investigational Site Number 076009 | Recife | Brazil | 52051-380 | |
| 199 | Sanofi-Aventis Investigational Site Number 076005 | Sao Jose Do Rio Preto | Brazil | 15015-210 | |
| 200 | Sanofi-Aventis Investigational Site Number 076010 | Sao Paulo | Brazil | 04024-002 | |
| 201 | Sanofi-Aventis Investigational Site Number 076015 | Uberlandia | Brazil | 38400 299 | |
| 202 | Sanofi-Aventis Investigational Site Number 100004 | Pleven | Bulgaria | 5800 | |
| 203 | Sanofi-Aventis Investigational Site Number 100005 | Plovdiv | Bulgaria | 4003 | |
| 204 | Sanofi-Aventis Investigational Site Number 100001 | Sofia | Bulgaria | 1309 | |
| 205 | Sanofi-Aventis Investigational Site Number 100002 | Sofia | Bulgaria | 1606 | |
| 206 | Sanofi-Aventis Investigational Site Number 100003 | Sofia | Bulgaria | 1618 | |
| 207 | Sanofi-Aventis Investigational Site Number 124014 | London | Canada | N6A 5A5 | |
| 208 | Sanofi-Aventis Investigational Site Number 124006 | Newmarket | Canada | L3Y 8C3 | |
| 209 | Sanofi-Aventis Investigational Site Number 124012 | Quebec | Canada | G1V 4G5 | |
| 210 | Sanofi-Aventis Investigational Site Number 124011 | Toronto | Canada | M5G 2C4 | |
| 211 | Sanofi-Aventis Investigational Site Number 152007 | Santiago | Chile | 750-0691 | |
| 212 | Sanofi-Aventis Investigational Site Number 152001 | Santiago | Chile | 8053095 | |
| 213 | Sanofi-Aventis Investigational Site Number 152003 | Santiago | Chile | ||
| 214 | Sanofi-Aventis Investigational Site Number 152004 | Santiago | Chile | ||
| 215 | Sanofi-Aventis Investigational Site Number 152005 | Santiago | Chile | ||
| 216 | Sanofi-Aventis Investigational Site Number 152008 | Santiago | Chile | ||
| 217 | Sanofi-Aventis Investigational Site Number 152009 | Viña Del Mar | Chile | 257-0017 | |
| 218 | Sanofi-Aventis Investigational Site Number 152006 | Viña Del Mar | Chile | ||
| 219 | Sanofi-Aventis Investigational Site Number 170003 | Bogota | Colombia | ||
| 220 | Sanofi-Aventis Investigational Site Number 170006 | Bogota | Colombia | ||
| 221 | Sanofi-Aventis Investigational Site Number 170001 | Bucaramanga | Colombia | ||
| 222 | Sanofi-Aventis Investigational Site Number 170005 | Envigado-Antioquia | Colombia | ||
| 223 | Sanofi-Aventis Investigational Site Number 170002 | Medellin | Colombia | ||
| 224 | Sanofi-Aventis Investigational Site Number 188004 | San José | Costa Rica | ||
| 225 | Sanofi-Aventis Investigational Site Number 191003 | Split | Croatia | 21000 | |
| 226 | Sanofi-Aventis Investigational Site Number 191001 | Zagreb | Croatia | 10000 | |
| 227 | Sanofi-Aventis Investigational Site Number 191004 | Zagreb | Croatia | 10000 | |
| 228 | Sanofi-Aventis Investigational Site Number 203005 | Chomutov | Czech Republic | 43012 | |
| 229 | Sanofi-Aventis Investigational Site Number 203003 | Jihlava | Czech Republic | 58633 | |
| 230 | Sanofi-Aventis Investigational Site Number 203009 | Ostrava Vitkovice | Czech Republic | 70300 | |
| 231 | Sanofi-Aventis Investigational Site Number 203001 | Pardubice | Czech Republic | 53203 | |
| 232 | Sanofi-Aventis Investigational Site Number 203011 | Plzen - Bory | Czech Republic | 30599 | |
| 233 | Sanofi-Aventis Investigational Site Number 203002 | Praha 2 | Czech Republic | 12808 | |
| 234 | Sanofi-Aventis Investigational Site Number 203004 | Praha 4 | Czech Republic | 14059 | |
| 235 | Sanofi-Aventis Investigational Site Number 203010 | Praha 6 | Czech Republic | 16902 | |
| 236 | Sanofi-Aventis Investigational Site Number 203006 | Prostejov | Czech Republic | 796 04 | |
| 237 | Sanofi-Aventis Investigational Site Number 203008 | Usti Nad Orlici | Czech Republic | 56218 | |
| 238 | Sanofi-Aventis Investigational Site Number 208002 | Glostrup | Denmark | 2600 | |
| 239 | Sanofi-Aventis Investigational Site Number 208001 | Hellerup | Denmark | 2900 | |
| 240 | Sanofi-Aventis Investigational Site Number 208007 | Hvidovre | Denmark | 2650 | |
| 241 | Sanofi-Aventis Investigational Site Number 208003 | København S | Denmark | 2300 | |
| 242 | Sanofi-Aventis Investigational Site Number 208004 | Odense | Denmark | 5000 | |
| 243 | Sanofi-Aventis Investigational Site Number 208006 | Roskilde | Denmark | 4000 | |
| 244 | Sanofi-Aventis Investigational Site Number 208005 | Svendborg | Denmark | 5700 | |
| 245 | Sanofi-Aventis Investigational Site Number 818002 | Alexandria | Egypt | ||
| 246 | Sanofi-Aventis Investigational Site Number 818003 | Alexandria | Egypt | ||
| 247 | Sanofi-Aventis Investigational Site Number 818004 | Alexandria | Egypt | ||
| 248 | Sanofi-Aventis Investigational Site Number 818001 | Cairo | Egypt | ||
| 249 | Sanofi-Aventis Investigational Site Number 233003 | Tallinn | Estonia | 10138 | |
| 250 | Sanofi-Aventis Investigational Site Number 233004 | Tallinn | Estonia | 13415 | |
| 251 | Sanofi-Aventis Investigational Site Number 233001 | Tallinn | Estonia | 13419 | |
| 252 | Sanofi-Aventis Investigational Site Number 233002 | Tartu | Estonia | 50410 | |
| 253 | Sanofi-Aventis Investigational Site Number 246001 | Helsinki | Finland | 00290 | |
| 254 | Sanofi-Aventis Investigational Site Number 250028 | Abbeville | France | 80142 | |
| 255 | Sanofi-Aventis Investigational Site Number 250012 | Albi Cedex 9 | France | 81013 | |
| 256 | Sanofi-Aventis Investigational Site Number 250034 | Allauch | France | 13190 | |
| 257 | Sanofi-Aventis Investigational Site Number 250031 | Belfort Cedex | France | 90016 | |
| 258 | Sanofi-Aventis Investigational Site Number 250011 | Bordeaux | France | 33076 | |
| 259 | Sanofi-Aventis Investigational Site Number 250010 | Brest Cedex 2 | France | 29609 | |
| 260 | Sanofi-Aventis Investigational Site Number 250021 | Brest | France | 29609 | |
| 261 | Sanofi-Aventis Investigational Site Number 250035 | Bron | France | 69677 | |
| 262 | Sanofi-Aventis Investigational Site Number 250022 | Cholet Cedex | France | 49300 | |
| 263 | Sanofi-Aventis Investigational Site Number 250018 | Dijon Cedex | France | 21034 | |
| 264 | Sanofi-Aventis Investigational Site Number 250006 | Dijon | France | 21033 | |
| 265 | Sanofi-Aventis Investigational Site Number 250004 | La Rochelle | France | 17019 | |
| 266 | Sanofi-Aventis Investigational Site Number 250029 | Le Chesnay Cedex | France | 78187 | |
| 267 | Sanofi-Aventis Investigational Site Number 250019 | Lille | France | 59020 | |
| 268 | Sanofi-Aventis Investigational Site Number 250015 | Lille | France | 59037 | |
| 269 | Sanofi-Aventis Investigational Site Number 250030 | Metz Tessy | France | 74370 | |
| 270 | Sanofi-Aventis Investigational Site Number 250003 | Montpellier | France | 34295 | |
| 271 | Sanofi-Aventis Investigational Site Number 250032 | Montpellier | France | 59523 | |
| 272 | Sanofi-Aventis Investigational Site Number 250016 | Nice Cedex | France | 06006 | |
| 273 | Sanofi-Aventis Investigational Site Number 250014 | Paris Cedex 13 | France | 75651 | |
| 274 | Sanofi-Aventis Investigational Site Number 250008 | Paris Cedex 14 | France | 75674 | |
| 275 | Sanofi-Aventis Investigational Site Number 250001 | Paris | France | 75018 | |
| 276 | Sanofi-Aventis Investigational Site Number 250005 | Saint Etienne Cedex 2 | France | 42055 | |
| 277 | Sanofi-Aventis Investigational Site Number 250026 | Toulouse Cedex 9 | France | 31059 | |
| 278 | Sanofi-Aventis Investigational Site Number 250027 | Tours Cedex 1 | France | 37044 | |
| 279 | Sanofi-Aventis Investigational Site Number 250002 | Vandoeuvre Les Nancy Cedex | France | 54511 | |
| 280 | Sanofi-Aventis Investigational Site Number 300009 | Athens | Greece | 11521 | |
| 281 | Sanofi-Aventis Investigational Site Number 300007 | Athens | Greece | 11527 | |
| 282 | Sanofi-Aventis Investigational Site Number 300002 | Athens | Greece | 11538 | |
| 283 | Sanofi-Aventis Investigational Site Number 300005 | Athens | Greece | ||
| 284 | Sanofi-Aventis Investigational Site Number 300006 | Chalkida | Greece | 34 100 | |
| 285 | Sanofi-Aventis Investigational Site Number 300004 | Chios | Greece | ||
| 286 | Sanofi-Aventis Investigational Site Number 300008 | Elefsina | Greece | 19600 | |
| 287 | Sanofi-Aventis Investigational Site Number 320002 | Guatemala | Guatemala | 01010 | |
| 288 | Sanofi-Aventis Investigational Site Number 320001 | Guatemala | Guatemala | 01014 | |
| 289 | Sanofi-Aventis Investigational Site Number 320003 | Guatemala | Guatemala | 01014 | |
| 290 | Sanofi-Aventis Investigational Site Number 320004 | Guatemala | Guatemala | ||
| 291 | Sanofi-Aventis Investigational Site Number 356001 | Ahmedabad | India | 380 015 | |
| 292 | Sanofi-Aventis Investigational Site Number 356010 | Ahmedabad | India | 380054 | |
| 293 | Sanofi-Aventis Investigational Site Number 356015 | Bangalore | India | 560034 | |
| 294 | Sanofi-Aventis Investigational Site Number 356009 | Bangalore | India | 562 150 | |
| 295 | Sanofi-Aventis Investigational Site Number 356005 | Chennai | India | 600 037 | |
| 296 | Sanofi-Aventis Investigational Site Number 356002 | Coimbatore | India | 641004 | |
| 297 | Sanofi-Aventis Investigational Site Number 356007 | Coimbatore | India | 641014 | |
| 298 | Sanofi-Aventis Investigational Site Number 356013 | Lucknow | India | 226003 | |
| 299 | Sanofi-Aventis Investigational Site Number 356006 | Lucknow | India | 226014 | |
| 300 | Sanofi-Aventis Investigational Site Number 356017 | Mumbai | India | 54 | |
| 301 | Sanofi-Aventis Investigational Site Number 356014 | Mysore | India | 570020 | |
| 302 | Sanofi-Aventis Investigational Site Number 356020 | Nashik | India | 42003 | |
| 303 | Sanofi-Aventis Investigational Site Number 356004 | New Delhi | India | 110060 | |
| 304 | Sanofi-Aventis Investigational Site Number 356012 | New Delhi | India | ||
| 305 | Sanofi-Aventis Investigational Site Number 356018 | Pune. | India | 400011 | |
| 306 | Sanofi-Aventis Investigational Site Number 356011 | Pune | India | 411004 | |
| 307 | Sanofi-Aventis Investigational Site Number 356003 | Secunderabad | India | 500 003 | |
| 308 | Sanofi-Aventis Investigational Site Number 360002 | Jakarta | Indonesia | 10430 | |
| 309 | Sanofi-Aventis Investigational Site Number 360001 | Jakarta | Indonesia | ||
| 310 | Sanofi-Aventis Investigational Site Number 376003 | Afula | Israel | 18101 | |
| 311 | Sanofi-Aventis Investigational Site Number 376015 | Ashkelon | Israel | 78278 | |
| 312 | Sanofi-Aventis Investigational Site Number 376001 | Givatayim | Israel | 53583 | |
| 313 | Sanofi-Aventis Investigational Site Number 376007 | Haifa | Israel | 31048 | |
| 314 | Sanofi-Aventis Investigational Site Number 376014 | Haifa | Israel | 31096 | |
| 315 | Sanofi-Aventis Investigational Site Number 376004 | Holon | Israel | 58100 | |
| 316 | Sanofi-Aventis Investigational Site Number 376012 | Nahariya | Israel | 22100 | |
| 317 | Sanofi-Aventis Investigational Site Number 376009 | Nazareth | Israel | 16100 | |
| 318 | Sanofi-Aventis Investigational Site Number 376011 | Rehovot | Israel | 76100 | |
| 319 | Sanofi-Aventis Investigational Site Number 376002 | Tel Aviv | Israel | 64239 | |
| 320 | Sanofi-Aventis Investigational Site Number 380015 | Ascoli Piceno | Italy | 63100 | |
| 321 | Sanofi-Aventis Investigational Site Number 380018 | Borgo San Lorenzo | Italy | 50032 | |
| 322 | Sanofi-Aventis Investigational Site Number 380016 | Chieti | Italy | 66013 | |
| 323 | Sanofi-Aventis Investigational Site Number 380005 | Fidenza | Italy | 43036 | |
| 324 | Sanofi-Aventis Investigational Site Number 380010 | Merate | Italy | 23807 | |
| 325 | Sanofi-Aventis Investigational Site Number 380014 | Milano | Italy | 20132 | |
| 326 | Sanofi-Aventis Investigational Site Number 380020 | Novara | Italy | 28100 | |
| 327 | Sanofi-Aventis Investigational Site Number 380001 | Padova | Italy | 35128 | |
| 328 | Sanofi-Aventis Investigational Site Number 380007 | Padova | Italy | 35128 | |
| 329 | Sanofi-Aventis Investigational Site Number 380004 | Palermo | Italy | 90127 | |
| 330 | Sanofi-Aventis Investigational Site Number 380008 | Pavia | Italy | 27100 | |
| 331 | Sanofi-Aventis Investigational Site Number 380021 | Perugia | Italy | 06132 | |
| 332 | Sanofi-Aventis Investigational Site Number 380013 | San Daniele Del Friuli | Italy | 33038 | |
| 333 | Sanofi-Aventis Investigational Site Number 380003 | Sassari | Italy | 07100 | |
| 334 | Sanofi-Aventis Investigational Site Number 380011 | Torino | Italy | 10144 | |
| 335 | Sanofi-Aventis Investigational Site Number 380009 | Treviso | Italy | 31100 | |
| 336 | Sanofi-Aventis Investigational Site Number 410008 | Anyang | Korea, Republic of | 431-070 | |
| 337 | Sanofi-Aventis Investigational Site Number 410002 | Daegu | Korea, Republic of | 700-712 | |
| 338 | Sanofi-Aventis Investigational Site Number 410006 | Goyang | Korea, Republic of | 411-706 | |
| 339 | Sanofi-Aventis Investigational Site Number 410012 | Goyang | Korea, Republic of | 411-773 | |
| 340 | Sanofi-Aventis Investigational Site Number 410007 | Gwangju | Korea, Republic of | 501-757 | |
| 341 | Sanofi-Aventis Investigational Site Number 410003 | Seongnam | Korea, Republic of | 463-802 | |
| 342 | Sanofi-Aventis Investigational Site Number 410001 | Seoul | Korea, Republic of | 134-701 | |
| 343 | Sanofi-Aventis Investigational Site Number 410004 | Seoul | Korea, Republic of | 135-710 | |
| 344 | Sanofi-Aventis Investigational Site Number 410005 | Seoul | Korea, Republic of | 138-736 | |
| 345 | Sanofi-Aventis Investigational Site Number 410011 | Seoul | Korea, Republic of | 140-210 | |
| 346 | Sanofi-Aventis Investigational Site Number 440004 | Kaunas | Lithuania | 3007 | |
| 347 | Sanofi-Aventis Investigational Site Number 440002 | Kaunas | Lithuania | LT-49456 | |
| 348 | Sanofi-Aventis Investigational Site Number 440003 | Vilnius | Lithuania | LT-07156 | |
| 349 | Sanofi-Aventis Investigational Site Number 440001 | Vilnius | Lithuania | LT-08661 | |
| 350 | Sanofi-Aventis Investigational Site Number 458001 | Kuching | Malaysia | 93586 | |
| 351 | Sanofi-Aventis Investigational Site Number 458002 | Penang | Malaysia | 10450 | |
| 352 | Sanofi-Aventis Investigational Site Number 458005 | Taiping | Malaysia | 34000 | |
| 353 | Sanofi-Aventis Investigational Site Number 484008 | Acapulco | Mexico | 39670 | |
| 354 | Sanofi-Aventis Investigational Site Number 484013 | Aguascalientes | Mexico | 20230 | |
| 355 | Sanofi-Aventis Investigational Site Number 484016 | Aguascalientes | Mexico | 20230 | |
| 356 | Sanofi-Aventis Investigational Site Number 484004 | Guadalajara | Mexico | 4428 | |
| 357 | Sanofi-Aventis Investigational Site Number 484007 | Guadalajara | Mexico | 44340 | |
| 358 | Sanofi-Aventis Investigational Site Number 484012 | Mexico Df | Mexico | 07300 | |
| 359 | Sanofi-Aventis Investigational Site Number 484010 | Monterrey | Mexico | 64060 | |
| 360 | Sanofi-Aventis Investigational Site Number 484011 | San Luis Potosi | Mexico | 72244 | |
| 361 | Sanofi-Aventis Investigational Site Number 484005 | San Luis Potosi | Mexico | 78200 | |
| 362 | Sanofi-Aventis Investigational Site Number 484003 | Veracruz | Mexico | 91700 | |
| 363 | Sanofi-Aventis Investigational Site Number 504001 | Marrakech | Morocco | 40000 | |
| 364 | Sanofi-Aventis Investigational Site Number 504002 | Meknes | Morocco | 50000 | |
| 365 | Sanofi-Aventis Investigational Site Number 528012 | Almelo | Netherlands | 7609 PP | |
| 366 | Sanofi-Aventis Investigational Site Number 528030 | Amsterdam | Netherlands | 1066 EC | |
| 367 | Sanofi-Aventis Investigational Site Number 528026 | Breda | Netherlands | 4818 CK | |
| 368 | Sanofi-Aventis Investigational Site Number 528009 | Delft | Netherlands | 2526 AD | |
| 369 | Sanofi-Aventis Investigational Site Number 528035 | Den Haag | Netherlands | 2545 CH | |
| 370 | Sanofi-Aventis Investigational Site Number 528027 | Ede | Netherlands | 6716 RP | |
| 371 | Sanofi-Aventis Investigational Site Number 528006 | Eindhoven | Netherlands | 5623 EJ | |
| 372 | Sanofi-Aventis Investigational Site Number 528017 | Eindhoven | Netherlands | 5623 EJ | |
| 373 | Sanofi-Aventis Investigational Site Number 528016 | Gouda | Netherlands | 2803 HH | |
| 374 | Sanofi-Aventis Investigational Site Number 528007 | Harderwijk | Netherlands | 3844 DG | |
| 375 | Sanofi-Aventis Investigational Site Number 528001 | Heerlen | Netherlands | 6419 PC | |
| 376 | Sanofi-Aventis Investigational Site Number 528024 | Heerlen | Netherlands | 6419 PC | |
| 377 | Sanofi-Aventis Investigational Site Number 528003 | Hengelo | Netherlands | 7555 DL | |
| 378 | Sanofi-Aventis Investigational Site Number 528010 | Hengelo | Netherlands | 7555 DL | |
| 379 | Sanofi-Aventis Investigational Site Number 528031 | Hoogeveen | Netherlands | 7909 AA | |
| 380 | Sanofi-Aventis Investigational Site Number 528019 | Hoorn | Netherlands | 1625 HV | |
| 381 | Sanofi-Aventis Investigational Site Number 528020 | Leeuwarden | Netherlands | 8934 AD | |
| 382 | Sanofi-Aventis Investigational Site Number 528004 | Nijmegen | Netherlands | 6532 SZ | |
| 383 | Sanofi-Aventis Investigational Site Number 528013 | Rotterdam | Netherlands | 3083 AN | |
| 384 | Sanofi-Aventis Investigational Site Number 528022 | Sittard-Geleen | Netherlands | 6162 BG | |
| 385 | Sanofi-Aventis Investigational Site Number 528002 | Sneek | Netherlands | 8601 ZK | |
| 386 | Sanofi-Aventis Investigational Site Number 528033 | Tilburg | Netherlands | 5022 GC | |
| 387 | Sanofi-Aventis Investigational Site Number 528021 | Venlo | Netherlands | 5912 BL | |
| 388 | Sanofi-Aventis Investigational Site Number 528005 | Zoetermeer | Netherlands | 2725 NA | |
| 389 | Sanofi-Aventis Investigational Site Number 528025 | Zwolle | Netherlands | 8011 JW | |
| 390 | Sanofi-Aventis Investigational Site Number 554003 | Christchurch | New Zealand | ||
| 391 | Sanofi-Aventis Investigational Site Number 554002 | Dunedin | New Zealand | ||
| 392 | Sanofi-Aventis Investigational Site Number 554001 | Nelson | New Zealand | ||
| 393 | Sanofi-Aventis Investigational Site Number 578001 | Bergen | Norway | 5021 | |
| 394 | Sanofi-Aventis Investigational Site Number 578006 | Flekkefjord | Norway | 4400 | |
| 395 | Sanofi-Aventis Investigational Site Number 578005 | Lørenskog | Norway | 1478 | |
| 396 | Sanofi-Aventis Investigational Site Number 578004 | Oslo | Norway | 0027 | |
| 397 | Sanofi-Aventis Investigational Site Number 591001 | Panama | Panama | ||
| 398 | Sanofi-Aventis Investigational Site Number 591002 | Panama | Panama | ||
| 399 | Sanofi-Aventis Investigational Site Number 591003 | Panama | Panama | ||
| 400 | Sanofi-Aventis Investigational Site Number 604004 | Lima | Peru | CALLAO 2 | |
| 401 | Sanofi-Aventis Investigational Site Number 604002 | Lima | Peru | Lima 11 | |
| 402 | Sanofi-Aventis Investigational Site Number 604001 | Lima | Peru | LIMA 13 | |
| 403 | Sanofi-Aventis Investigational Site Number 604005 | Lima | Peru | LIMA 31 | |
| 404 | Sanofi-Aventis Investigational Site Number 604003 | Lima | Peru | LIMA 41 | |
| 405 | Sanofi-Aventis Investigational Site Number 608001 | Quezon City | Philippines | 1102 | |
| 406 | Sanofi-Aventis Investigational Site Number 616013 | Chojnice | Poland | 89-600 | |
| 407 | Sanofi-Aventis Investigational Site Number 616011 | Gdansk | Poland | 81-756 | |
| 408 | Sanofi-Aventis Investigational Site Number 616014 | Gdynia-Redlowo | Poland | 81-402 | |
| 409 | Sanofi-Aventis Investigational Site Number 616009 | Katowice | Poland | 40-635 | |
| 410 | Sanofi-Aventis Investigational Site Number 616017 | Lodz | Poland | 91-425 | |
| 411 | Sanofi-Aventis Investigational Site Number 616002 | Lublin | Poland | 20-954 | |
| 412 | Sanofi-Aventis Investigational Site Number 616012 | Ostrowiec Swietokrzyski | Poland | 27-400 | |
| 413 | Sanofi-Aventis Investigational Site Number 616015 | Pulawy | Poland | 24-100 | |
| 414 | Sanofi-Aventis Investigational Site Number 616007 | Torun | Poland | 87-100 | |
| 415 | Sanofi-Aventis Investigational Site Number 616006 | Tychy | Poland | 43-100 | |
| 416 | Sanofi-Aventis Investigational Site Number 616001 | Warszawa | Poland | 02-005 | |
| 417 | Sanofi-Aventis Investigational Site Number 616010 | Warszawa | Poland | 02-097 | |
| 418 | Sanofi-Aventis Investigational Site Number 616008 | Wroclaw | Poland | 50-349 | |
| 419 | Sanofi-Aventis Investigational Site Number 620002 | Amadora | Portugal | 2720-276 | |
| 420 | Sanofi-Aventis Investigational Site Number 620007 | Braga | Portugal | 4701-968 | |
| 421 | Sanofi-Aventis Investigational Site Number 620006 | Coimbra | Portugal | 3000-075 | |
| 422 | Sanofi-Aventis Investigational Site Number 620008 | Setubal | Portugal | 2910-446 | |
| 423 | Sanofi-Aventis Investigational Site Number 630001 | San Juan | Puerto Rico | 00921-3201 | |
| 424 | Sanofi-Aventis Investigational Site Number 643033 | Barnaul | Russian Federation | 656055 | |
| 425 | Sanofi-Aventis Investigational Site Number 643040 | Chelyabinsk | Russian Federation | 454048 | |
| 426 | Sanofi-Aventis Investigational Site Number 643050 | Chelyabinsk | Russian Federation | 454092 | |
| 427 | Sanofi-Aventis Investigational Site Number 643036 | Chelyabinsk | Russian Federation | 454136 | |
| 428 | Sanofi-Aventis Investigational Site Number 643031 | Ekaterinburg | Russian Federation | 620109 | |
| 429 | Sanofi-Aventis Investigational Site Number 643009 | Kemerovo | Russian Federation | 650002 | |
| 430 | Sanofi-Aventis Investigational Site Number 643042 | Kemerovo | Russian Federation | 650002 | |
| 431 | Sanofi-Aventis Investigational Site Number 643015 | Moscow | Russian Federation | 105066 | |
| 432 | Sanofi-Aventis Investigational Site Number 643032 | Moscow | Russian Federation | 109263 | |
| 433 | Sanofi-Aventis Investigational Site Number 643007 | Moscow | Russian Federation | 111539 | |
| 434 | Sanofi-Aventis Investigational Site Number 643020 | Moscow | Russian Federation | 117292 | |
| 435 | Sanofi-Aventis Investigational Site Number 643054 | Moscow | Russian Federation | 117342 | |
| 436 | Sanofi-Aventis Investigational Site Number 643052 | Moscow | Russian Federation | 117556 | |
| 437 | Sanofi-Aventis Investigational Site Number 643056 | Moscow | Russian Federation | 119415 | |
| 438 | Sanofi-Aventis Investigational Site Number 643025 | Moscow | Russian Federation | 119435 | |
| 439 | Sanofi-Aventis Investigational Site Number 643053 | Moscow | Russian Federation | 119435 | |
| 440 | Sanofi-Aventis Investigational Site Number 643028 | Moscow | Russian Federation | 121359 | |
| 441 | Sanofi-Aventis Investigational Site Number 643037 | Moscow | Russian Federation | 121359 | |
| 442 | Sanofi-Aventis Investigational Site Number 643001 | Moscow | Russian Federation | 121552 | |
| 443 | Sanofi-Aventis Investigational Site Number 643026 | Moscow | Russian Federation | 121552 | |
| 444 | Sanofi-Aventis Investigational Site Number 643039 | Moscow | Russian Federation | 121552 | |
| 445 | Sanofi-Aventis Investigational Site Number 643011 | Moscow | Russian Federation | 127473 | |
| 446 | Sanofi-Aventis Investigational Site Number 643034 | Moscow | Russian Federation | 127473 | |
| 447 | Sanofi-Aventis Investigational Site Number 643049 | Moscow | Russian Federation | 129090 | |
| 448 | Sanofi-Aventis Investigational Site Number 643030 | Moscow | Russian Federation | 129336 | |
| 449 | Sanofi-Aventis Investigational Site Number 643013 | Nizhny Novgorod | Russian Federation | 603003 | |
| 450 | Sanofi-Aventis Investigational Site Number 643041 | Nizniy Novgorod | Russian Federation | 603005 | |
| 451 | Sanofi-Aventis Investigational Site Number 643048 | Novosibirsk-117 | Russian Federation | 630117 | |
| 452 | Sanofi-Aventis Investigational Site Number 643051 | Novosibirsk | Russian Federation | 630008 | |
| 453 | Sanofi-Aventis Investigational Site Number 643044 | Novosibirsk | Russian Federation | 630091 | |
| 454 | Sanofi-Aventis Investigational Site Number 643045 | Penza | Russian Federation | ||
| 455 | Sanofi-Aventis Investigational Site Number 643023 | Perm | Russian Federation | 614097 | |
| 456 | Sanofi-Aventis Investigational Site Number 643006 | Perm | Russian Federation | 614107 | |
| 457 | Sanofi-Aventis Investigational Site Number 643046 | Petrozavodsk | Russian Federation | 185019 | |
| 458 | Sanofi-Aventis Investigational Site Number 643012 | Rostov-Na-Donu | Russian Federation | 344068 | |
| 459 | Sanofi-Aventis Investigational Site Number 643008 | Ryazan | Russian Federation | 390026 | |
| 460 | Sanofi-Aventis Investigational Site Number 643017 | Saint-Petersburg | Russian Federation | 197022 | |
| 461 | Sanofi-Aventis Investigational Site Number 643047 | Saint-Petersburg | Russian Federation | 197022 | |
| 462 | Sanofi-Aventis Investigational Site Number 643029 | Samara | Russian Federation | 443070 | |
| 463 | Sanofi-Aventis Investigational Site Number 643004 | Saratov | Russian Federation | 410028 | |
| 464 | Sanofi-Aventis Investigational Site Number 643005 | Saratov | Russian Federation | 410028 | |
| 465 | Sanofi-Aventis Investigational Site Number 643003 | Saratov | Russian Federation | 410054 | |
| 466 | Sanofi-Aventis Investigational Site Number 643022 | St-Petersburg | Russian Federation | 192242 | |
| 467 | Sanofi-Aventis Investigational Site Number 643038 | St-Petersburg | Russian Federation | 194354 | |
| 468 | Sanofi-Aventis Investigational Site Number 643016 | St-Petersburg | Russian Federation | 196247 | |
| 469 | Sanofi-Aventis Investigational Site Number 643018 | St-Petersburg | Russian Federation | 197110 | |
| 470 | Sanofi-Aventis Investigational Site Number 643010 | St-Petersburg | Russian Federation | 198013 | |
| 471 | Sanofi-Aventis Investigational Site Number 643027 | St-Petersburg | Russian Federation | 198013 | |
| 472 | Sanofi-Aventis Investigational Site Number 643002 | St-Petersburg | Russian Federation | 199106 | |
| 473 | Sanofi-Aventis Investigational Site Number 643024 | Tomsk | Russian Federation | 634012 | |
| 474 | Sanofi-Aventis Investigational Site Number 643035 | Tomsk | Russian Federation | 634012 | |
| 475 | Sanofi-Aventis Investigational Site Number 643021 | Tyumen | Russian Federation | 625023 | |
| 476 | Sanofi-Aventis Investigational Site Number 643043 | Voronezh | Russian Federation | 394006 | |
| 477 | Sanofi-Aventis Investigational Site Number 643019 | Yaroslavl | Russian Federation | 150062 | |
| 478 | Sanofi-Aventis Investigational Site Number 703003 | Kosice | Slovakia | 04015 | |
| 479 | Sanofi-Aventis Investigational Site Number 703005 | Levice | Slovakia | ||
| 480 | Sanofi-Aventis Investigational Site Number 703004 | Nitra | Slovakia | 950 01 | |
| 481 | Sanofi-Aventis Investigational Site Number 703006 | Poprad | Slovakia | 05845 | |
| 482 | Sanofi-Aventis Investigational Site Number 703002 | Trnava | Slovakia | 91775 | |
| 483 | Sanofi-Aventis Investigational Site Number 710013 | Amanzimtoti | South Africa | ||
| 484 | Sanofi-Aventis Investigational Site Number 710011 | Bloemfontein | South Africa | ||
| 485 | Sanofi-Aventis Investigational Site Number 710007 | Cape Town | South Africa | 7129 | |
| 486 | Sanofi-Aventis Investigational Site Number 710017 | Cape Town | South Africa | 7764 | |
| 487 | Sanofi-Aventis Investigational Site Number 710001 | Durban | South Africa | 4092 | |
| 488 | Sanofi-Aventis Investigational Site Number 710012 | Durban | South Africa | ||
| 489 | Sanofi-Aventis Investigational Site Number 710009 | Johannesburg | South Africa | 1449 | |
| 490 | Sanofi-Aventis Investigational Site Number 710016 | Port Elizabeth | South Africa | ||
| 491 | Sanofi-Aventis Investigational Site Number 710020 | Pretoria | South Africa | 0050 | |
| 492 | Sanofi-Aventis Investigational Site Number 710003 | Pretoria | South Africa | 0084 | |
| 493 | Sanofi-Aventis Investigational Site Number 710002 | Pretoria | South Africa | 0204 | |
| 494 | Sanofi-Aventis Investigational Site Number 710015 | Randburg | South Africa | 2194 | |
| 495 | Sanofi-Aventis Investigational Site Number 710014 | Scottburgh | South Africa | ||
| 496 | Sanofi-Aventis Investigational Site Number 710018 | Umhlanga Rocks | South Africa | 4400 | |
| 497 | Sanofi-Aventis Investigational Site Number 724003 | Barcelona | Spain | 08003 | |
| 498 | Sanofi-Aventis Investigational Site Number 724002 | Barcelona | Spain | 08036 | |
| 499 | Sanofi-Aventis Investigational Site Number 724001 | Madrid | Spain | 28046 | |
| 500 | Sanofi-Aventis Investigational Site Number 724005 | Santiago De Compostela | Spain | 15706 | |
| 501 | Sanofi-Aventis Investigational Site Number 724007 | Sevilla | Spain | 41006 | |
| 502 | Sanofi-Aventis Investigational Site Number 752003 | Göteborg | Sweden | 413 45 | |
| 503 | Sanofi-Aventis Investigational Site Number 752006 | Göteborg | Sweden | 413 45 | |
| 504 | Sanofi-Aventis Investigational Site Number 752007 | Malmo | Sweden | 211 52 | |
| 505 | Sanofi-Aventis Investigational Site Number 752002 | Malmö | Sweden | 20502 | |
| 506 | Sanofi-Aventis Investigational Site Number 752004 | Ostersund | Sweden | 831 83 | |
| 507 | Sanofi-Aventis Investigational Site Number 752001 | Stockolm | Sweden | SE-171 76 | |
| 508 | Sanofi-Aventis Investigational Site Number 158003 | Kaohsiung | Taiwan | 833 | |
| 509 | Sanofi-Aventis Investigational Site Number 158002 | Taichung | Taiwan | ||
| 510 | Sanofi-Aventis Investigational Site Number 158004 | Tainan Hsien | Taiwan | 710 | |
| 511 | Sanofi-Aventis Investigational Site Number 158001 | Taipei | Taiwan | ||
| 512 | Sanofi-Aventis Investigational Site Number 158005 | Taipei | Taiwan | ||
| 513 | Sanofi-Aventis Investigational Site Number 764002 | Bangkok-Noi | Thailand | 10700 | |
| 514 | Sanofi-Aventis Investigational Site Number 764001 | Bangkok | Thailand | 10330 | |
| 515 | Sanofi-Aventis Investigational Site Number 764003 | Muang | Thailand | 50200 | |
| 516 | Sanofi-Aventis Investigational Site Number 792004 | Edirne | Turkey | ||
| 517 | Sanofi-Aventis Investigational Site Number 792005 | Edirne | Turkey | ||
| 518 | Sanofi-Aventis Investigational Site Number 792002 | Istanbul | Turkey | 34034 | |
| 519 | Sanofi-Aventis Investigational Site Number 792001 | Istanbul | Turkey | ||
| 520 | Sanofi-Aventis Investigational Site Number 792003 | Istanbul | Turkey | ||
| 521 | Sanofi-Aventis Investigational Site Number 792006 | Kocaeli | Turkey | 41300 | |
| 522 | Sanofi-Aventis Investigational Site Number 792007 | Kocaeli | Turkey | 41380 | |
| 523 | Sanofi-Aventis Investigational Site Number 804013 | Dnepropetrovsk | Ukraine | ||
| 524 | Sanofi-Aventis Investigational Site Number 804015 | Dnepropetrovsk | Ukraine | ||
| 525 | Sanofi-Aventis Investigational Site Number 804005 | Dnipropetrovsk | Ukraine | ||
| 526 | Sanofi-Aventis Investigational Site Number 804008 | Ivano-Frankivsk | Ukraine | ||
| 527 | Sanofi-Aventis Investigational Site Number 804004 | Kharkiv | Ukraine | ||
| 528 | Sanofi-Aventis Investigational Site Number 804002 | Kharkov | Ukraine | ||
| 529 | Sanofi-Aventis Investigational Site Number 804012 | Kharkov | Ukraine | ||
| 530 | Sanofi-Aventis Investigational Site Number 804003 | Kiev | Ukraine | ||
| 531 | Sanofi-Aventis Investigational Site Number 804007 | Lutsk | Ukraine | ||
| 532 | Sanofi-Aventis Investigational Site Number 804009 | Lutsk | Ukraine | ||
| 533 | Sanofi-Aventis Investigational Site Number 804011 | Odessa | Ukraine | ||
| 534 | Sanofi-Aventis Investigational Site Number 804010 | Ternopil | Ukraine | ||
| 535 | Sanofi-Aventis Investigational Site Number 804006 | Uzhgorod | Ukraine | ||
| 536 | Sanofi-Aventis Investigational Site Number 804014 | Zaporizhzhia | Ukraine | ||
| 537 | Sanofi-Aventis Investigational Site Number 862001 | Caracas | Venezuela | ||
| 538 | Sanofi-Aventis Investigational Site Number 862002 | Maracay | Venezuela | 2103 |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Sanofi
ClinicalTrials.gov Identifier:
NCT00580216
Other Study ID Numbers:
- EFC10295
- 2007-004817-33
First Posted:
Dec 24, 2007
Last Update Posted:
Mar 21, 2016
Last Verified:
Feb 1, 2016
Keywords provided by Sanofi
Additional relevant MeSH terms: