ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab
Public ClinicalTrials.gov record NCT01663402. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Alirocumab (SAR236553/REGN727) on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV) events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina (UA) requiring hospitalization) in participants who experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with evidence-based medical and dietary management of dyslipidemia. Secondary Objectives: * To evaluate the effect of alirocumab on secondary endpoints (any CHD event , major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, CHD deaths, CV deaths, all cause mortality). * To evaluate the safety and tolerability of alirocumab. * To evaluate the effect of alirocumab on lipid parameters.
Study identification
- NCT ID
- NCT01663402
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 18,924 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2012
- Primary completion
- Jan 22, 2018
- Completion
- Jan 22, 2018
- Last update posted
- Mar 17, 2019
2012 – 2018
United States locations
- U.S. sites
- 273
- U.S. states
- 42
- U.S. cities
- 221
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840163 | Birmingham | Alabama | 35235 | — |
| Investigational Site Number 840060 | Birmingham | Alabama | 35294 | — |
| Investigational Site Number 840117 | Huntsville | Alabama | 35801 | — |
| Investigational Site Number 840192 | Huntsville | Alabama | 35801 | — |
| Investigational Site Number 840121 | Mobile | Alabama | 36604 | — |
| Investigational Site Number 840319 | Mobile | Alabama | 36695 | — |
| Investigational Site Number 840332 | Atlantis | Arizona | 33462 | — |
| Investigational Site Number 840320 | Newport Beach | Arizona | 92663 | — |
| Investigational Site Number 840103 | Tucson | Arizona | 85724 | — |
| Investigational Site Number 840084 | Tucson | Arizona | — | — |
| Investigational Site Number 840139 | Banning | California | — | — |
| Investigational Site Number 840286 | Beverly Hills | California | 90210 | — |
| Investigational Site Number 840246 | Beverly Hills | California | 90211 | — |
| Investigational Site Number 840353 | Beverly Hills | California | 90211 | — |
| Investigational Site Number 840341 | Carmichael | California | 95608 | — |
| Investigational Site Number 840299 | Chula Vista | California | 91910 | — |
| Investigational Site Number 840164 | Fresno | California | 93721 | — |
| Investigational Site Number 840076 | Fullerton | California | 92835 | — |
| Investigational Site Number 840073 | Huntington Beach | California | 92648 | — |
| Investigational Site Number 840092 | La Jolla | California | 92093 | — |
| Investigational Site Number 840208 | Long Beach | California | 90801 | — |
| Investigational Site Number 840068 | Long Beach | California | 90822 | — |
| Investigational Site Number 840269 | Los Alamitos | California | 90720 | — |
| Investigational Site Number 840009 | Los Angeles | California | 90073 | — |
| Investigational Site Number 840282 | Los Angeles | California | 90095 | — |
| Investigational Site Number 840019 | Mission Viejo | California | 92691 | — |
| Investigational Site Number 840336 | Moreno Valley | California | 92553 | — |
| Investigational Site Number 840124 | Northridge | California | 91325 | — |
| Investigational Site Number 840251 | Pasadena | California | 91105 | — |
| Investigational Site Number 840289 | Pasadena | California | 91105 | — |
| Investigational Site Number 840312 | Port Hueneme | California | 93041 | — |
| Investigational Site Number 840261 | San Diego | California | 92120 | — |
| Investigational Site Number 840310 | San Diego | California | 92120 | — |
| Investigational Site Number 840024 | San Diego | California | — | — |
| Investigational Site Number 840071 | Santa Ana | California | 92704 | — |
| Investigational Site Number 840236 | Santa Rosa | California | 95405 | — |
| Investigational Site Number 840012 | Torrance | California | — | — |
| Investigational Site Number 840096 | Aurora | Colorado | 80012 | — |
| Investigational Site Number 840037 | Colorado Springs | Colorado | 80909 | — |
| Investigational Site Number 840189 | Denver | Colorado | 80220 | — |
| Investigational Site Number 840122 | Bridgeport | Connecticut | 06606 | — |
| Investigational Site Number 840219 | Guilford | Connecticut | 06437 | — |
| Investigational Site Number 840347 | Altamonte Springs | Florida | 32714 | — |
| Investigational Site Number 840066 | Clearwater | Florida | 33756 | — |
| Investigational Site Number 840079 | Daytona Beach | Florida | 32114 | — |
| Investigational Site Number 840051 | Daytona Beach | Florida | 32117 | — |
| Investigational Site Number 840368 | Delray Beach | Florida | 33484 | — |
| Investigational Site Number 840242 | Fort Lauderdale | Florida | 33308 | — |
| Investigational Site Number 840134 | Gainesville | Florida | 32608 | — |
| Investigational Site Number 840327 | Hollywood | Florida | 33021 | — |
| Investigational Site Number 840153 | Hudson | Florida | 34667 | — |
| Investigational Site Number 840105 | Hudson | Florida | — | — |
| Investigational Site Number 840253 | Jacksonville | Florida | 32204 | — |
| Investigational Site Number 840141 | Jacksonville | Florida | 32209 | — |
| Investigational Site Number 840042 | Jacksonville | Florida | 32216 | — |
| Investigational Site Number 840206 | Jacksonville | Florida | 32216 | — |
| Investigational Site Number 840063 | Jacksonville | Florida | 32258 | — |
| Investigational Site Number 840002 | Jupiter | Florida | 33458 | — |
| Investigational Site Number 840119 | Largo | Florida | — | — |
| Investigational Site Number 840241 | Miami Beach | Florida | 33140 | — |
| Investigational Site Number 840210 | Mount Clemens | Florida | — | — |
| Investigational Site Number 840366 | New Port Richey | Florida | 34653 | — |
| Investigational Site Number 840311 | Palm Beach Gardens | Florida | 33410 | — |
| Investigational Site Number 840280 | Palm Harbor | Florida | 34684 | — |
| Investigational Site Number 840054 | Panama City | Florida | 32401 | — |
| Investigational Site Number 840239 | Pembroke Pines | Florida | 33024 | — |
| Investigational Site Number 840044 | Pensacola | Florida | 32501 | — |
| Investigational Site Number 840367 | Plantation | Florida | 33317 | — |
| Investigational Site Number 840132 | Safety Harbor | Florida | 34695 | — |
| Investigational Site Number 840061 | Safety Harbor | Florida | — | — |
| Investigational Site Number 840247 | Sarasota | Florida | 34239 | — |
| Investigational Site Number 840264 | Tampa | Florida | 33606 | — |
| Investigational Site Number 840082 | Tampa | Florida | 33613 | — |
| Investigational Site Number 840213 | Trinity | Florida | 34655 | — |
| Investigational Site Number 840165 | Wellington | Florida | 33449 | — |
| Investigational Site Number 840323 | West Palm Beach | Florida | 33401 | — |
| Investigational Site Number 840075 | Atlanta | Georgia | — | — |
| Investigational Site Number 840176 | Augusta | Georgia | 30901 | — |
| Investigational Site Number 840048 | Covington | Georgia | 30014 | — |
| Investigational Site Number 840065 | Cumming | Georgia | 30041 | — |
| Investigational Site Number 840356 | Thomasville | Georgia | 31792 | — |
| Investigational Site Number 840114 | Tucker | Georgia | 30084 | — |
| Investigational Site Number 840211 | Idaho Falls | Idaho | 83404 | — |
| Investigational Site Number 840237 | Arlington Heights | Illinois | 60005 | — |
| Investigational Site Number 840292 | Chicago | Illinois | 60612 | — |
| Investigational Site Number 840146 | Harvey | Illinois | 60426 | — |
| Investigational Site Number 840340 | Joliet | Illinois | 60435 | — |
| Investigational Site Number 840196 | Peoria | Illinois | 61614 | — |
| Investigational Site Number 840081 | Rock Island | Illinois | 61201 | — |
| Investigational Site Number 840090 | Rock Island | Illinois | 61201 | — |
| Investigational Site Number 840358 | Elkhart | Indiana | 46514 | — |
| Investigational Site Number 840036 | Hammond | Indiana | 46320 | — |
| Investigational Site Number 840026 | Indianapolis | Indiana | — | — |
| Investigational Site Number 840102 | Muncie | Indiana | 47303-3400 | — |
| Investigational Site Number 840145 | South Bend | Indiana | 46601-1075 | — |
| Investigational Site Number 840154 | Ames | Iowa | 50010 | — |
| Investigational Site Number 840345 | Iowa City | Iowa | — | — |
| Investigational Site Number 840283 | West Des Moines | Iowa | 50266 | — |
| Investigational Site Number 840335 | Kansas City | Kansas | 64116 | — |
| Investigational Site Number 840089 | Kansas City | Kansas | 66160-7321 | — |
| Investigational Site Number 840218 | Kansas City | Kansas | — | — |
| Investigational Site Number 840140 | Overland Park | Kansas | 66209 | — |
| Investigational Site Number 840030 | Lexington | Kentucky | — | — |
| Investigational Site Number 840023 | Louisville | Kentucky | 40205 | — |
| Investigational Site Number 840007 | Louisville | Kentucky | 40207 | — |
| Investigational Site Number 840279 | Owensboro | Kentucky | 42303 | — |
| Investigational Site Number 840308 | Pikeville | Kentucky | 41501 | — |
| Investigational Site Number 840181 | Saint Paul | Kentucky | 55102 | — |
| Investigational Site Number 840254 | Alexandria | Louisiana | 71301 | — |
| Investigational Site Number 840344 | Lafayette | Louisiana | 70503 | — |
| Investigational Site Number 840187 | Lake Charles | Louisiana | 70601 | — |
| Investigational Site Number 840291 | Minden | Louisiana | 71055 | — |
| Investigational Site Number 840278 | New Orleans | Louisiana | 70112 | — |
| Investigational Site Number 840290 | Shreveport | Louisiana | 71103 | — |
| Investigational Site Number 840142 | Auburn | Maine | 04210 | — |
| Investigational Site Number 840148 | Auburn | Maine | — | — |
| Investigational Site Number 840097 | Bangor | Maine | 04401 | — |
| Investigational Site Number 840234 | Framingham | Maine | 01702 | — |
| Investigational Site Number 840276 | Scarborough | Maine | 04074 | — |
| Investigational Site Number 840351 | Annapolis | Maryland | 21401 | — |
| Investigational Site Number 840072 | Beltsville | Maryland | — | — |
| Investigational Site Number 840193 | Bethesda | Maryland | 20817 | — |
| Investigational Site Number 840200 | Columbia | Maryland | 21044 | — |
| Investigational Site Number 840349 | Rockville | Maryland | 20850 | — |
| Investigational Site Number 840111 | Winfield | Maryland | — | — |
| Investigational Site Number 840056 | Boston | Massachusetts | 02111 | — |
| Investigational Site Number 840144 | Flint | Michigan | 48532 | — |
| Investigational Site Number 840365 | Grandville | Michigan | 49418 | — |
| Investigational Site Number 840093 | Kalamazoo | Michigan | — | — |
| Investigational Site Number 840198 | Lansing | Michigan | 48910 | — |
| Investigational Site Number 840087 | Rochester Hills | Michigan | 48085 | — |
| Investigational Site Number 840004 | Springfield | Michigan | 65807 | — |
| Investigational Site Number 840267 | Springfield | Michigan | — | — |
| Investigational Site Number 840035 | Ypsilanti | Michigan | 48197 | — |
| Investigational Site Number 840199 | Duluth | Minnesota | 55805 | — |
| Investigational Site Number 840116 | Edina | Minnesota | 55435 | — |
| Investigational Site Number 840281 | Minneapolis | Minnesota | 55407 | — |
| Investigational Site Number 840094 | Saint Cloud | Minnesota | 56303 | — |
| Investigational Site Number 840324 | Saint Paul | Minnesota | 55101 | — |
| Investigational Site Number 840046 | Columbia | Missouri | 65201 | — |
| Investigational Site Number 840180 | Independence | Missouri | 64057 | — |
| Investigational Site Number 840013 | Marquette | Missouri | — | — |
| Investigational Site Number 840179 | Overland | Missouri | — | — |
| Investigational Site Number 840228 | St Louis | Missouri | 63128 | — |
| Investigational Site Number 840233 | St Louis | Missouri | 63128 | — |
| Investigational Site Number 840235 | St Louis | Missouri | 63128 | — |
| Investigational Site Number 840175 | St Louis | Missouri | 63136 | — |
| Investigational Site Number 840125 | St Louis | Missouri | 63141 | — |
| Investigational Site Number 840168 | St Louis | Missouri | — | — |
| Investigational Site Number 840274 | Thomure | Missouri | — | — |
| Investigational Site Number 840032 | Kalispell | Montana | 59901 | — |
| Investigational Site Number 840033 | Grand Island | Nebraska | 68803 | — |
| Investigational Site Number 840015 | Omaha | Nebraska | 68122 | — |
| Investigational Site Number 840021 | Omaha | Nebraska | 68122 | — |
| Investigational Site Number 840001 | Omaha | Nebraska | — | — |
| Investigational Site Number 840221 | Las Vegas | Nevada | 89146 | — |
| Investigational Site Number 840062 | Nashua | New Hampshire | 03060 | — |
| Investigational Site Number 840077 | Bridgewater | New Jersey | 08807 | — |
| Investigational Site Number 840173 | Bridgewater | New Jersey | — | — |
| Investigational Site Number 840127 | Flemington | New Jersey | 08822 | — |
| Investigational Site Number 840359 | Hackensack | New Jersey | 07601 | — |
| Investigational Site Number 840348 | Moorestown | New Jersey | 08057 | — |
| Investigational Site Number 840128 | New Brunswick | New Jersey | 08903-0019 | — |
| Investigational Site Number 840167 | Pomona | New Jersey | 08240 | — |
| Investigational Site Number 840067 | Ridgewood | New Jersey | 07506 | — |
| Investigational Site Number 840250 | Somerset | New Jersey | 08873 | — |
| Investigational Site Number 840277 | Voorhees Township | New Jersey | 08043 | — |
| Investigational Site Number 840083 | Westwood | New Jersey | — | — |
| Investigational Site Number 840322 | Buffalo | New York | 14215 | — |
| Investigational Site Number 840248 | New York | New York | 10016 | — |
| Investigational Site Number 840371 | New York | New York | — | — |
| Investigational Site Number 840333 | Newburgh | New York | 47630 | — |
| Investigational Site Number 840017 | Poughkeepsie | New York | 12601 | — |
| Investigational Site Number 840222 | The Bronx | New York | 10467 | — |
| Investigational Site Number 840166 | Valhalla | New York | 10595 | — |
| Investigational Site Number 840354 | Williamsville | New York | 14221 | — |
| Investigational Site Number 840070 | Elizabeth City | North Carolina | 27909 | — |
| Investigational Site Number 840303 | Greenville | North Carolina | 27834 | — |
| Investigational Site Number 840182 | Greenville | North Carolina | — | — |
| Investigational Site Number 840243 | Raleigh | North Carolina | 27610 | — |
| Investigational Site Number 840342 | Raleigh | North Carolina | 27610 | — |
| Investigational Site Number 840293 | Rocky Mount | North Carolina | 27804 | — |
| Investigational Site Number 840088 | Statesville | North Carolina | 28627 | — |
| Investigational Site Number 840052 | Wilmington | North Carolina | 28401 | — |
| Investigational Site Number 840214 | Fargo | North Dakota | — | — |
| Investigational Site Number 840306 | Glasston | North Dakota | 21229 | — |
| Investigational Site Number 840095 | Minot | North Dakota | 58701 | — |
| Investigational Site Number 840257 | Mountain Lakes | North Dakota | — | — |
| Investigational Site Number 840364 | Akron | Ohio | 44304 | — |
| Investigational Site Number 840131 | Cincinnati | Ohio | — | — |
| Investigational Site Number 840045 | Columbus | Ohio | 43210 | — |
| Investigational Site Number 840265 | Columbus | Ohio | 43210 | — |
| Investigational Site Number 840113 | Lorain | Ohio | 44053 | — |
| Investigational Site Number 840115 | Lorain | Ohio | 44053 | — |
| Investigational Site Number 840309 | Maumee | Ohio | 43537 | — |
| Investigational Site Number 840297 | Springfield | Ohio | 45505 | — |
| Investigational Site Number 840172 | Toledo | Ohio | 43623 | — |
| Investigational Site Number 840263 | Youngstown | Ohio | 44501 | — |
| Investigational Site Number 840334 | Oklahoma City | Oklahoma | 73104 | — |
| Investigational Site Number 840337 | Oklahoma City | Oklahoma | 73120 | — |
| Investigational Site Number 840018 | Tulsa | Oklahoma | 74104 | — |
| Investigational Site Number 840184 | Portland | Oregon | 97239 | — |
| Investigational Site Number 840133 | Allentown | Pennsylvania | 18102 | — |
| Investigational Site Number 840104 | Beaver | Pennsylvania | 15009 | — |
| Investigational Site Number 840170 | Camp Hill | Pennsylvania | 17011 | — |
| Investigational Site Number 840020 | Doylestown | Pennsylvania | 18901 | — |
| Investigational Site Number 840016 | Erie | Pennsylvania | 16502-4604 | — |
| Investigational Site Number 840329 | Goodyear | Pennsylvania | 85395 | — |
| Investigational Site Number 840126 | Knoxville | Pennsylvania | — | — |
| Investigational Site Number 840249 | Lancaster | Pennsylvania | 17603 | — |
| Investigational Site Number 840150 | Lancaster | Pennsylvania | — | — |
| Investigational Site Number 840231 | Philadelphia | Pennsylvania | 19085 | — |
| Investigational Site Number 840339 | Philadelphia | Pennsylvania | 19104 | — |
| Investigational Site Number 840230 | Pittsburgh | Pennsylvania | 15240 | — |
| Investigational Site Number 840028 | Sayre | Pennsylvania | 18840 | — |
| Investigational Site Number 840069 | Scranton | Pennsylvania | 18503 | — |
| Investigational Site Number 840316 | Scranton | Pennsylvania | 18510 | — |
| Investigational Site Number 840273 | Seven Fields | Pennsylvania | 16046 | — |
| Investigational Site Number 840227 | Washington | Pennsylvania | — | — |
| Investigational Site Number 840129 | Pawtucket | Rhode Island | 02860 | — |
| Investigational Site Number 840118 | Anderson | South Carolina | 29621 | — |
| Investigational Site Number 840190 | Greenwood | South Carolina | — | — |
| Investigational Site Number 840360 | Lancaster | South Carolina | 29720 | — |
| Investigational Site Number 840314 | Myrtle Beach | South Carolina | 29572 | — |
| Investigational Site Number 840008 | Rapid City | South Dakota | 57701 | — |
| Investigational Site Number 840285 | Chattanooga | Tennessee | 37421 | — |
| Investigational Site Number 840287 | Jackson | Tennessee | 38301 | — |
| Investigational Site Number 840040 | Johnson City | Tennessee | 37604 | — |
| Investigational Site Number 840238 | Knoxville | Tennessee | 37917-4524 | — |
| Investigational Site Number 840195 | Oak Ridge | Tennessee | 37830 | — |
| Investigational Site Number 840205 | Amarillo | Texas | 79106 | — |
| Investigational Site Number 840352 | Amarillo | Texas | 79106 | — |
| Investigational Site Number 840135 | Austin | Texas | 78756 | — |
| Investigational Site Number 840301 | Dallas | Texas | 75226 | — |
| Investigational Site Number 840152 | Dallas | Texas | 75231 | — |
| Investigational Site Number 840157 | Dallas | Texas | 75390 | — |
| Investigational Site Number 840229 | Fort Worth | Texas | 76104 | — |
| Investigational Site Number 840120 | Fort Worth | Texas | 76107 | — |
| Investigational Site Number 840258 | Fort Worth | Texas | — | — |
| Investigational Site Number 840136 | Kingwood | Texas | 77339 | — |
| Investigational Site Number 840027 | Lubbock | Texas | 79410 | — |
| Investigational Site Number 840202 | Lufkin | Texas | 75904 | — |
| Investigational Site Number 840270 | Odessa | Texas | 79761 | — |
| Investigational Site Number 840162 | San Antonio | Texas | 78229 | — |
| Investigational Site Number 840232 | San Antonio | Texas | 78229 | — |
| Investigational Site Number 840328 | Schertz | Texas | 78154 | — |
| Investigational Site Number 840158 | Tyler | Texas | 75701 | — |
| Investigational Site Number 840318 | Victoria | Texas | 77901 | — |
| Investigational Site Number 840245 | Wichita Falls | Texas | — | — |
| Investigational Site Number 840256 | Orem | Utah | 84058 | — |
| Investigational Site Number 840296 | Salt Lake City | Utah | 84124 | — |
| Investigational Site Number 840053 | Burlington | Vermont | 05401 | — |
| Investigational Site Number 840049 | Charlottesville | Virginia | 22908-0679 | — |
| Investigational Site Number 840260 | Charlottesville | Virginia | — | — |
| Investigational Site Number 840350 | Harrisonburg | Virginia | 22801 | — |
| Investigational Site Number 840215 | Leesburg | Virginia | — | — |
| Investigational Site Number 840010 | Lynchburg | Virginia | 24501 | — |
| Investigational Site Number 840225 | Manassas | Virginia | 20109 | — |
| Investigational Site Number 840022 | Richmond | Virginia | 23225 | — |
| Investigational Site Number 840078 | Richmond | Virginia | 23249 | — |
| Investigational Site Number 840110 | Richmond | Virginia | 23298 | — |
| Investigational Site Number 840149 | Roanoke | Virginia | 24014 | — |
| Investigational Site Number 840223 | Winchester | Virginia | 22601 | — |
| Investigational Site Number 840025 | Bellevue | Washington | 98004 | — |
| Investigational Site Number 840321 | Everett | Washington | 98201 | — |
| Investigational Site Number 840326 | Spokane | Washington | 99204 | — |
| Investigational Site Number 840086 | Tacoma | Washington | 98415-0299 | — |
| Investigational Site Number 840295 | Walla Walla | Washington | 99362 | — |
| Investigational Site Number 840262 | Burlington | Wisconsin | 53105 | — |
| Investigational Site Number 840298 | Green Bay | Wisconsin | 54303 | — |
| Investigational Site Number 840059 | Green Bay | Wisconsin | — | — |
| Investigational Site Number 840177 | La Crosse | Wisconsin | 54601 | — |
| Investigational Site Number 840300 | Manitowoc | Wisconsin | 54220 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1115 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01663402, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 17, 2019 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01663402 live on ClinicalTrials.gov.