ClinicalTrials.gov record
Clopidogrel and the Optimization of Gastrointestinal Events (COGENT-1)
ClinicalTrials.gov ID: NCT00557921
Public ClinicalTrials.gov record NCT00557921. 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, Double-Dummy, Parallel Group, Phase 3 Efficacy and Safety Study of CGT-2168 Compared With Clopidogrel to Reduce Upper Gastrointestinal Events Including Bleeding and Symptomatic Ulcer Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the COGENT-1 clinical trial is to determine whether CGT-2168 (clopidogrel and omeprazole) compared to clopidogrel is safe and effective in reducing the incidence of gastrointestinal bleeding and symptomatic ulcer disease, in the setting of concomitant aspirin therapy. Antiplatelet therapy is an essential element of care for patients with atherothrombotic disease. Bleeding is a fundamental adverse effect of all antiplatelet drugs including aspirin, clopidogrel and dual antiplatelet regimens. The gastrointestinal tract is the most common site of bleeding related to antiplatelet therapy, typically in connection with peptic ulcer disease. Recently published studies suggest the use of clopidogrel carries a gastrointestinal bleeding risk similar to that of aspirin or non-aspirin non-steroidal anti-inflammatory drugs. Patients taking any two of these drugs (clopidogrel, aspirin and/or non-aspirin NSAIDs) are exposed to an even higher risk of bleeding and ulcer disease. Cogentus Pharmaceuticals is launching phase 3 trials of a novel combination product, CGT-2168, which has the potential to significantly reduce this problem and increase patient safety. CGT-2168 combines a standard dosage of clopidogrel and a gastroprotectant (omeprazole) in a once-daily pill that may reduce the likelihood of adverse gastrointestinal events.
Study identification
- NCT ID
- NCT00557921
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 5,000 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 21 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
- Nov 30, 2007
- Primary completion
- Oct 31, 2009
- Completion
- Oct 31, 2009
- Last update posted
- Jan 27, 2009
2007 – 2009
United States locations
- U.S. sites
- 247
- U.S. states
- 43
- U.S. cities
- 208
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Research Institute, Inc. (ACRI) | Alexander City | Alabama | 35010 | — |
| Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35126 | — |
| Cardio-Thoracic Surgeons P.C. | Birmingham | Alabama | 35213 | — |
| Birmingham Heart Clinic, PC | Birmingham | Alabama | 35235 | — |
| John F Simmons , MD PC | Geneva | Alabama | 36340 | — |
| Clinical Research Consultants, Inc. | Hoover | Alabama | 35216 | — |
| The Heart Center, PC | Huntsville | Alabama | 35801 | — |
| Mobile Heart Specialists, PC | Mobile | Alabama | 36608 | — |
| Advanced Cardiac Specialists | Mesa | Arizona | 85206 | — |
| Redpoint Research | Phoenix | Arizona | 85029 | — |
| Cardiovascular Consultants, Ltd. | Phoenix | Arizona | 85032 | — |
| Cochise Clinical Research | Sierra Vista | Arizona | 85635 | — |
| Paradigm Clinical Research, Inc. | Tucson | Arizona | 85705 | — |
| Tri-Lakes Research | Hot Springs | Arkansas | 71901 | — |
| Michael A. Frais, Cardiologist, P.A. | Hot Springs | Arkansas | 71913 | — |
| NEA-Clinic Cardiology | Jonesboro | Arkansas | 72401 | — |
| Searcy Medical Center | Searcy | Arkansas | 72143 | — |
| Cardiology Consultants of Orange County | Anaheim | California | 92801 | — |
| Chest and Critical Care Consultants, A Medical Group | Anaheim | California | 92801 | — |
| Clinical Solutions Advantage | Buena Park | California | 90620 | — |
| Turns Institute for Clinical Research | Castro Valley | California | 94546 | — |
| Escondido Cardiology Associates | Escondido | California | 92025 | — |
| Accurate Clinical Trials, Inc. | Laguna Hills | California | 92653 | — |
| Therapeutic Research Institute of Orange County | Laguna Hills | California | 92653 | — |
| Kirtik Thaker MD | Lakewood | California | 90712 | — |
| Los Angeles Cardiology Associates | Los Angeles | California | 90017 | — |
| Merced Heart Associates | Merced | California | 95348 | — |
| Mission Internal Medical Group | Mission Viejo | California | 92691 | — |
| Altos Cardiovascular Associates | Mountain View | California | 94040 | — |
| Kenneth W. Carr, MD, Cardiology | Oceanside | California | 92056 | — |
| Rancho CucamongaClinical Trials | Rancho Cucamonga | California | 91703 | — |
| Inland Heart and Vascular Medical Associates | San Bernardino | California | 92404 | — |
| Ritchken and First | San Diego | California | 92117 | — |
| Rider Research Group | San Francisco | California | 94117 | — |
| Richard Levy, MD. | San Francisco | California | 94118 | — |
| Kaiser Permanente | San Jose | California | 95119 | — |
| Medical Helping Hands Research | Santa Ana | California | 92704 | — |
| Pacific Heart Institute | Santa Monica | California | 90404 | — |
| Radiant Research | Santa Rosa | California | 95405 | — |
| Harbor- UCLA Medical Center | Torrance | California | 90509 | — |
| Ventura Cardiology Consultants Medical Group, Inc. | Ventura | California | 93003 | — |
| Colorado Springs Health Partners | Colorado Springs | Colorado | 80907 | — |
| Connecticut Clinical Research | Bridgeport | Connecticut | 06606 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| Alfieri Cardiology, PA | Newark | Delaware | 19713 | — |
| Washington V.A. Medical Center | Washington D.C. | District of Columbia | 20422 | — |
| Oscar R. Guerra, MD PA | Coral Gables | Florida | 33134 | — |
| Deerfield Beach Cardiology Associates | Deerfield Beach | Florida | 33442 | — |
| Dr Jules Cohen | Hallandale | Florida | 33009 | — |
| Empire International Research | Hialeah | Florida | 33012 | — |
| Cardiovascular Consultants of South Florida | Hollywood | Florida | 33021 | — |
| Jacksonville Heart Center | Jacksonville | Florida | 32207 | — |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | — |
| Jacksonville Heart Center | Jacksonville | Florida | 32250 | — |
| CVMS Resesarch Institute, LLC | Jupiter | Florida | 33458 | — |
| Watson Clinic Center for Research | Lakeland | Florida | 33805 | — |
| Alpha Medical Research, LLC | Melbourne | Florida | 32901 | — |
| Empire International Research | Miami | Florida | 33125 | — |
| Suncoast Research Group, LLC | Miami | Florida | 33144 | — |
| Cardiovascular Research Center of South Florida | Miami | Florida | 33173 | — |
| Research Center Phase I-IV of Florida Corp. | Miami | Florida | 33175 | — |
| Empire International Research | Miami | Florida | 33186 | — |
| Bert Fish Medical Center | New Smyrna Beach | Florida | 32168 | — |
| Central Florida Cardiology Group | Orlando | Florida | 32803 | — |
| Cardiology Assocaites of Orlando d/b/a Orlando Heart Center | Orlando | Florida | 32806 | — |
| Sunset Point Medical Associates | Palm Harbor | Florida | 34684 | — |
| Berma Research Group | Plantation | Florida | 33317 | — |
| Charlotte Heart Group Research Center | Port Charlotte | Florida | 33952 | — |
| Suncoast Cardiovascular Research | St. Petersburg | Florida | 33701 | — |
| The Heart and Vascular Institute of Florida | St. Petersburg | Florida | 33709 | — |
| G&G Research Baker-Tombul Cardiology | Vero Beach | Florida | 32960 | — |
| Carlos Levy, D.O. | Weston | Florida | 33326 | — |
| Piedmont Hospital | Atlanta | Georgia | 30309 | — |
| Primary Care Specialists, LLC/ ECAST CT | Atlanta | Georgia | 30312 | — |
| Executive Health and Research Associates, Inc. | Atlanta | Georgia | 30342 | — |
| Southeast Regional Research Group | Columbus | Georgia | 31904 | — |
| Georgia Heart Specialists, LLC | Covington | Georgia | 30014 | — |
| Ialum Clinical Research Center, LLC | Decatur | Georgia | 30032 | — |
| Ialum Clinical Research Center | Decatur | Georgia | 30032 | — |
| Ialum Clinical Research Center | Decatur | Georgia | 30035 | — |
| Southeast Regional Research Group | Savannah | Georgia | 31406 | — |
| Medsouth Primary CareStockbridge | Stockbridge | Georgia | 30281 | — |
| South Suburban Health Professional Group, PC | Flossmoor | Illinois | 60422 | — |
| Consultants in Cardiovascular Medicine | Melrose Park | Illinois | 60160 | — |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61606 | — |
| Community Clinical Research Center | Anderson | Indiana | 46011 | — |
| American Health Network | Avon | Indiana | 46123 | — |
| Indiana Medical Research | Elkhart | Indiana | 46514 | — |
| Welborn Clinic | Evansville | Indiana | 47713 | — |
| Indiana Heart Physicians | Indianapolis | Indiana | 46237 | — |
| Midwest Cardiovascular Research Foundation | Davenport | Iowa | 52803 | — |
| Northeast Iowa Medical Education Foundation | Waterloo | Iowa | 50702 | — |
| Hutchinson Clinic, P.A. | Hutchinson | Kansas | 67502 | — |
| Venture Resource Group, Inc. | Mission | Kansas | 66202 | — |
| Midwest Cardiology Assocaites | Overland Park | Kansas | 66209 | — |
| Cumberland Cardiology | Ashland | Kentucky | 41101 | — |
| Trover Health System | Madisonville | Kentucky | 42431 | — |
| Owensboro Heart and Vascular | Owensboro | Kentucky | 42303 | — |
| Dolby Research, LLC | Baton Rouge | Louisiana | 33437 | — |
| Cardiovascular Institute of the South | Houma | Louisiana | 70301 | — |
| Heart Clinic of Louisiana Clinical Research, LLC. | Marrero | Louisiana | 70072 | — |
| Maine Research Associates | Auburn | Maine | 04210 | — |
| Cardiovascular Consultants of Maine, PA | Scarborough | Maine | 04074 | — |
| Maine Cardiology Associates | South Portland | Maine | 04106 | — |
| Good Samaritan Hospital (Medstar Health) | Baltimore | Maryland | 21239 | — |
| eCast Corporation | Greenbelt | Maryland | 20770 | — |
| Atlantic Cardiology Associates, P.A | Salisbury | Maryland | 21801 | — |
| Peninsula Cardiology Associates | Salisbury | Maryland | 21804 | — |
| Pentucket Medical Associates | Haverhill | Massachusetts | 01830 | — |
| Charles River Medical Associates | Natick | Massachusetts | 01760 | — |
| Michigan Cardiovascular Institute | Bay City | Michigan | 48708 | — |
| Apex Medical Research, AMR, Inc. | Flint | Michigan | 48504 | — |
| Borgess Research Institute | Kalamazoo | Michigan | 49048 | — |
| Michigan Cardiovascular Institute | Midland | Michigan | 48670 | — |
| Michigan Cardiovascular Institute | Saginaw | Michigan | 48601 | — |
| Covenant Medical Center, Inc. | Saginaw | Michigan | 48602 | — |
| Academic Heart and Vascular PLLC | Saint Clair Shores | Michigan | 48081 | — |
| Oakland Medical Center | Troy | Michigan | 48085 | — |
| Waterford Medical Assoc. P.C. | Waterford | Michigan | 48328 | — |
| Michigan Heart, PC | Ypsilanti | Michigan | 48106 | — |
| Duluth Clinic / Saint Marys Medical Center | Duluth | Minnesota | 55805 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Regions Hospital | Saint Paul | Minnesota | 55101 | — |
| New Coast Cardiology Center, PLLC | Gulfport | Mississippi | 39503 | — |
| PPS Clinical Research, STL, LLC | Chesterfield | Missouri | 63017 | — |
| Kansas City VA Medical Center | Kansas City | Missouri | 64128 | — |
| Cardiology Diagnostics, Ltd. | St Louis | Missouri | 63122 | — |
| Glacier View Cardiology | Kalispell | Montana | 59901 | — |
| Saint Patrick Hospital- International Heart Institute of Montana | Missoula | Montana | 59802 | — |
| The Creighton Cardiac Center | Omaha | Nebraska | 68131 | — |
| Alegent Health Clinic Heart and Vascular Specialist | Papillion | Nebraska | 68046 | — |
| Nevada Cardiology Associates | Las Vegas | Nevada | 89128 | — |
| Lahey Cardiology @ the Medical Center | Nashua | New Hampshire | 03060 | — |
| Associated Cardiovascular Consultants | Cherry Hill | New Jersey | 08034 | — |
| Cardiovascular Associates of the Delaware Valley, P.A. | Elmer | New Jersey | 08318 | — |
| Cardiovascular Associates of the Delaware Valley, P.A. | Haddon Heights | New Jersey | 08035 | — |
| Cardiovascular Associates of the Delaware Valley, P.A. | Sewell | New Jersey | 08080 | — |
| Physicans Research Center, LLC | Toms River | New Jersey | 08755 | — |
| Capital Cardiology Associates | Albany | New York | 12211 | — |
| Hudson Valley Cardiology Group, P.C. | Cortlandt Manor | New York | 10567 | — |
| Cardiology Associates, P.C. | Johnson City | New York | 13790 | — |
| Long Island Heart Associates | Mineola | New York | 11501 | — |
| Slocum-Dickson Medical Group, PLLC | New Hartford | New York | 13413 | — |
| Sound Shore Cardiology, P.C. | New Rochelle | New York | 10801 | — |
| New York Cardiovascular Associate | New York | New York | 10001 | — |
| St. Luke's- Roosevelt Hospital | New York | New York | 10025 | — |
| Rochester General Hospital | Rochester | New York | 14621 | — |
| Saratoga Cardiology Assoc, PC | Saratoga Springs | New York | 12866 | — |
| Westchester Cardiology Associates | Scarsdale | New York | 10583 | — |
| Good Samaritan Hospital | Suffern | New York | 10901 | — |
| Cardiology, PC | Syracuse | New York | 13210 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| Cardiac Care and Vascular Medicine, Albert Einstein College of Medicine | The Bronx | New York | 10469 | — |
| Capital Cardiology Associates | Troy | New York | 12180 | — |
| Buffalo Cardiology and Pulmonary Associates | Williamsville | New York | 14221 | — |
| Mark J. Kozinn, MD | Williamsville | New York | 14221 | — |
| Clinical Study Center of Asheville, LLC | Asheville | North Carolina | 28803 | — |
| Kernodle Clinic, Inc. | Burlington | North Carolina | 27215 | — |
| Metrolina Medical Research | Charlotte | North Carolina | 28209 | — |
| Diversified Research | Durham | North Carolina | 27704 | — |
| Cumberland Research Associates, LLC | Fayetteville | North Carolina | 28304 | — |
| Cardiovascular Care of Northern Carolina | Oxford | North Carolina | 27565 | — |
| St. Alexius Medical Center | Bismarck | North Dakota | 58501 | — |
| Altru Health Systems | Grand Forks | North Dakota | 58201 | — |
| Trinity Health | Minot | North Dakota | 58701 | — |
| George G. Ellis, Jr. M.D., Inc. | Boardman | Ohio | 44512 | — |
| Cardiovascular Research Institute, LLC | Canton | Ohio | 44710 | — |
| Comprehensive Cardiology Consultants, Inc. | Cincinnati | Ohio | 45236 | — |
| Midwest Cardiology Research Foundation | Columbus | Ohio | 43214 | — |
| Prestige Clinical Research | Franklin | Ohio | 45005 | — |
| St. Vincent Mercy Medical Center | Toledo | Ohio | 43608 | — |
| Cardiology Associates of SE Ohio, Inc | Zanesville | Ohio | 43701 | — |
| Physicans Research, Inc. | Zanesville | Ohio | 43701 | — |
| Bluestem Cardiology Research Dept. | Bartlesville | Oklahoma | 74006 | — |
| Oklahoma Cardiovascular Research Group | Oklahoma City | Oklahoma | 73109 | — |
| Aquilo Research | Yukon | Oklahoma | 73099 | — |
| Bend Memorial Clinic | Bend | Oregon | 97701 | — |
| Hillsboro Cardiology, PC | Hillsboro | Oregon | 97123 | — |
| Legacy Clinical Research | Portland | Oregon | 97210 | — |
| Abington Medical Specialists | Abington | Pennsylvania | 19001 | — |
| Tri-State Medical Group | Beaver | Pennsylvania | 15009 | — |
| Heritage Cardiology Association | Camp Hill | Pennsylvania | 17011 | — |
| Premier Heart Specialists | Easton | Pennsylvania | 18042 | — |
| Heart Specialists of Lancaster | Ephrata | Pennsylvania | 17522 | — |
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Pennsylvania Heart and Vascular Group, P.C. | Jenkintown | Pennsylvania | 19046 | — |
| Comprehensive Cardiology Consultants | Langhorne | Pennsylvania | 19047 | — |
| Sewickley Valley Medical Group Cardiology | Leetsdale | Pennsylvania | 15056 | — |
| Cardiology Consultants of Philadelphia | Norristown | Pennsylvania | 19401 | — |
| Hospital of the University of Pennsylvania Cardiology Department | Philadelphia | Pennsylvania | 19104 | — |
| Cardiology Consultants of Philadelphia | Philadelphia | Pennsylvania | 19111 | — |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | — |
| Cardiology Consultants of Philadelphia | Philadelphia | Pennsylvania | 19148 | — |
| VA Pittsburgh Healthcare System | Pittsburgh | Pennsylvania | 15240 | — |
| Advanced Cardiology Specialists | Scranton | Pennsylvania | 18501 | — |
| Elite Medical Research, Inc. | Sellersville | Pennsylvania | 18960 | — |
| Cardiology Consultants of Philadelphia | Upland | Pennsylvania | 19013 | — |
| West Chester Cardiology, PC | West Chester | Pennsylvania | 19380 | — |
| Berks Cardiology, Ltd. | Wyomissing | Pennsylvania | 19610 | — |
| Cardiology Consultants of Philadelphia | Yardley | Pennsylvania | 19067 | — |
| New England Center for Clinical Research, Inc | Cranston | Rhode Island | 02920 | — |
| Rhode Island Hospital Cardiology | Providence | Rhode Island | 02903 | — |
| Cardiology Specialists | Westerly | Rhode Island | 02891 | — |
| Palmetto Clinical Research | Summerville | South Carolina | 29485 | — |
| McMinn Medical Group (DBA: Athens Medical Group) | Athens | Tennessee | 37303 | — |
| Verzosa & Ungab Internal Medicine Associates | Bartlett | Tennessee | 38134 | — |
| Middle Tennessee Clinical Research | Fayetteville | Tennessee | 37334 | — |
| Research Associates of Jackson and Apex Cardiology | Jackson | Tennessee | 38301 | — |
| Tri-State Cardiology | Johnson City | Tennessee | 37601 | — |
| Memphis Internal Medicine | Memphis | Tennessee | 38119 | — |
| Goodlife Medical Center | Memphis | Tennessee | 38120 | — |
| Heart and Vascular Clinic | Nashville | Tennessee | 37203 | — |
| Family Health Care Assoc. | Arlington | Texas | 76013 | — |
| Southeast Texas Clinical Research Center | Beaumont | Texas | 77702 | — |
| Trinity Hypertension and Diagnostic Res. | Carrollton | Texas | 75006 | — |
| VA Medical Center | Dallas | Texas | 75216 | — |
| U.T. Southwestern | Dallas | Texas | 75390 | — |
| Amir Malik Research | Fort Worth | Texas | 76104 | — |
| The University of Texas Medical Branch at Galveston | Galveston | Texas | 77555-0553 | — |
| East Texas Cardiology PA | Houston | Texas | 77002 | — |
| Office of Amer Zaheer, MD | Houston | Texas | 77004 | — |
| Office of Salim Gopalani, MD | Houston | Texas | 77008 | — |
| Comprehensive Heart Care, PA | Houston | Texas | 77024 | — |
| Century Clinical Research | Houston | Texas | 77036 | — |
| Office of Mizra Basith Baig, MD | Houston | Texas | 77055 | — |
| Covenant Cardiology Associates | Lubbock | Texas | 79410 | — |
| South Texas Institutes of Health | McAllen | Texas | 78572 | — |
| Texas Regional Heart Center d/b/a Legacy Heart Center | Plano | Texas | 75024 | — |
| Heart & Vascular Institute of Texas | San Antonio | Texas | 78217 | — |
| Cardiology Clinic of San Antonio | San Antonio | Texas | 78229 | — |
| South Texas Cardiovascular Consultants | San Antonio | Texas | 78229 | — |
| IMED Research, PA | San Antonio | Texas | 78258 | — |
| Southwest Health Associate, PA | Sugar Land | Texas | 77478 | — |
| Office of Dwayne O. Williams, MD | Sugarland | Texas | 77479 | — |
| Kings Daughters Clinic | Temple | Texas | 76502 | — |
| Victoria Heart and Vascular Center | Victoria | Texas | 77901 | — |
| Cardiology Consultants of Danville | Danville | Virginia | 24541 | — |
| Triad Research Institute | Galax | Virginia | 24333 | — |
| Virginia Cardiovascular Specialists | Richmond | Virginia | 23226 | — |
| Winchester Medical Center/ Clinical Research Department | Winchester | Virginia | 22601 | — |
| Daniel W. Gottlieb, MD, PS | Burien | Washington | 98166 | — |
| Heart Clinic Northwest | Spokane | Washington | 99204 | — |
| Inland Cardiology Assocaites | Spokane | Washington | 99204 | — |
| Franciscan Health System dba FHS Research Center | Tacoma | Washington | 98405 | — |
| Parkersburg Cardiology Associates | Parkersburg | West Virginia | 26101 | — |
| Wisconsin Heart, S.C. | Madison | Wisconsin | 53715 | — |
| Heart Care Associates, LLC | Milwaukee | Wisconsin | 53215 | — |
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 244 non-U.S. sites.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00557921, 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 Jan 27, 2009 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00557921 live on ClinicalTrials.gov.