Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment
Sponsor
Kowa Research Institute, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03011450
Collaborator
(none)
471
241
2
31.2
2
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients With Fasting High Triglyceride Levels ≥500 mg/dL and <2000 mg/dL and Mild or Moderate Renal Impairment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
471 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Actual Study Start Date
:
Nov 26, 2016
Actual Primary Completion Date
:
Jul 5, 2019
Actual Study Completion Date
:
Jul 5, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: 12 Week Efficacy K-877 or placebo comparator for 12 weeks |
Drug: K-877
Drug: Placebo (for K-877)
|
| Active Comparator: 40 week extension K-877 or fenofibrate comparator for 40 weeks |
Drug: K-877
Drug: Fenofibrate
|
Outcome Measures
Primary Outcome Measures
- Percent change of fasting triglyceride(TG) levels [12 Weeks]
Secondary Outcome Measures
- Percent change of fasting TG levels [52 Weeks]
- Percent change of other lipid perimeter [12 Weeks and 52 Weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Able to understand and willing to comply with all study requirements and procedures throughout the duration of the study and give written informed consent;
-
Aged ≥18 years;
-
Patients receiving moderate- or high-intensity statin therapy must meet one of the following criteria¹ unless they have any exceptional conditions (see inclusion criterion 4):
-
Aged ≥21 years with clinical atherosclerotic cardiovascular disease (ASCVD) (history of acute coronary syndrome or myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack [TIA] presumed to be of atherosclerotic origin, or peripheral arterial disease or revascularization), on a high-intensity statin (or moderate-intensity statin if not a candidate for high-intensity statin due to safety concerns);
-
Aged ≥21 years with a history of LDL-C ≥190 mg/dL, which is not due to secondary modifiable causes, on a high-intensity statin (or moderate-intensity statin if not a candidate for high-intensity statin due to safety concerns);
-
Aged 40 to 75 years, inclusive, without clinical ASCVD but with diabetes and a history of LDL-C of 70 to 189 mg/dL, inclusive, on a moderate- or high-intensity statin; or
-
Aged 40 to 75 years, inclusive, without clinical ASCVD or diabetes, with a history of LDL-C of 70 to 189 mg/dL, inclusive, with estimated 10-year risk for ASCVD of ≥7.5% by the Pooled Cohort Equation on a moderate- or high-intensity statin;
-
Patients currently on a low-intensity statin or not on a statin, must meet one of the following criteria;
-
Patient does not meet any criteria for moderate- or high-intensity statin therapy listed above (see inclusion criteria, 3.a. through 3.d.);
-
Patient does meet one or more criteria for moderate- or high-intensity statin therapy listed above (see inclusion criteria 3.a. through 3.d.); but the patient is not a candidate for moderate or high-intensity statin due to safety concerns, or due to partial or complete statin intolerance; or
-
Patient does meet one or more criteria for moderate- or high intensity statin therapy listed above (see inclusion criteria 3.b. through 3.d., except for 3.a.); but the patient is not a candidate for moderate or high intensity statin for primary prevention after considering individual risk evaluation (e.g. current LDL C ≤70mg/dL) and patient preference;
-
Fasting TG levels ≥500 mg/dL (5.65 mmol/L) and <2000 mg/dL (22.60 mmol/L) based on the mean of Visit 2 (Week -2) and Visit 3 (Week -1).
- Mild to moderate renal impairment eGFR >= 30mL/min/1.73 and < 90 mL/min/1.73 at Visit 1
Exclusion Criteria:
-
Patients who will require lipid-altering treatments other than study drugs (K-877 or fenofibrate), statins, ezetimibe, or PCSK9 inhibitors during the course of the study. These include bile acid sequestrants, non-study fibrates, niacin (>100 mg/day), omega-3 fatty acids (>1000 mg/day), or any supplements used to alter lipid metabolism including, but not limited to, red rice yeast supplements, garlic supplements, soy isoflavone supplements, sterol/stanol products, or policosanols;
-
Body mass index (BMI) >45 kg/m2 at Visit 1 (Week -8 or Week -6);
-
Patients with type 1 diabetes mellitus;
-
Patients with newly diagnosed (within 3 months prior to Visit 2 [Week -2]) or poorly controlled type 2 diabetes mellitus (T2DM), defined as hemoglobin A1c >9.5% at Visit 1 (Week -8 or Week -6);
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Central Research Associates, Inc. | Birmingham | Alabama | United States | 35205 |
| 2 | Central Alabama Research | Birmingham | Alabama | United States | 35209 |
| 3 | Cahaba Research, Inc. | Birmingham | Alabama | United States | 35242 |
| 4 | Boyett Health Services Inc | Hamilton | Alabama | United States | 35570 |
| 5 | Longwood Research - Saadat Ansari, MD, LLC | Huntsville | Alabama | United States | 35801 |
| 6 | Terence T. Hart, MD | Tuscumbia | Alabama | United States | 35674 |
| 7 | Arrowhead Health Centers | Glendale | Arizona | United States | 85306 |
| 8 | Phoenix Medical Research Institute, LLC | Peoria | Arizona | United States | 85381 |
| 9 | Elite Clinical Studies | Phoenix | Arizona | United States | 85018 |
| 10 | Clinical Research Institute of Arizona, LLC | Surprise | Arizona | United States | 85374 |
| 11 | iResearch | Little Rock | Arkansas | United States | 72205 |
| 12 | Lynn Institute of the Ozarks | Little Rock | Arkansas | United States | 72205 |
| 13 | Advanced Research Center | Anaheim | California | United States | 92805 |
| 14 | Torrance Clinical Research Institute Inc. | Lomita | California | United States | 90717 |
| 15 | Downtown L.A. Research Center, Inc. | Los Angeles | California | United States | 90017 |
| 16 | Catalina Research Institute, LLC | Montclair | California | United States | 91763 |
| 17 | Pacific Coast Cardiology and Research | Newport Beach | California | United States | 92663 |
| 18 | Lucita M. Cruz, MD., Inc. | Norwalk | California | United States | 90650 |
| 19 | Integrated Research Center | San Diego | California | United States | 92117 |
| 20 | Optimus Medical Group | San Francisco | California | United States | 94102 |
| 21 | Creekside Endocrine Associates, PC | Denver | Colorado | United States | 80246 |
| 22 | Atlantic Clinical Research Collaborative | Boynton Beach | Florida | United States | 33472 |
| 23 | ALL Medical Research, LLC | Cooper City | Florida | United States | 33024 |
| 24 | S & W Clinical Research | Fort Lauderdale | Florida | United States | 33306 |
| 25 | Indago Research and Health Center | Hialeah | Florida | United States | 33012 |
| 26 | Jacksonville Impotence Treatment Center | Jacksonville | Florida | United States | 32223 |
| 27 | AMPM Research Clinic | Miami Gardens | Florida | United States | 33169 |
| 28 | Advanced Research Institute Inc | New Port Richey | Florida | United States | 34653 |
| 29 | Ocala Cardiovascular Research | Ocala | Florida | United States | 34474 |
| 30 | South Florida Research Solutions LLC. | Pembroke Pines | Florida | United States | 33029 |
| 31 | Progressive Medical Research | Port Orange | Florida | United States | 32127 |
| 32 | Cardiovascular Center of Sarasota | Sarasota | Florida | United States | 34239 |
| 33 | Meridien Research - Tampa | Tampa | Florida | United States | 33634 |
| 34 | Meridien Research | Tampa | Florida | United States | 33634 |
| 35 | Columbus Regional Health | Columbus | Georgia | United States | 31904 |
| 36 | iResearch | Decatur | Georgia | United States | 30030 |
| 37 | Physicians Research Associates, Inc | Lawrenceville | Georgia | United States | 30046 |
| 38 | Georgia Institute for Clinical Research | Marietta | Georgia | United States | 30060 |
| 39 | Endocrine Research Solutions, Inc | Roswell | Georgia | United States | 30076 |
| 40 | Meridian Clinical Research - Savannah, GA | Savannah | Georgia | United States | 31406 |
| 41 | Solaris Clinical Research | Meridian | Idaho | United States | 83646 |
| 42 | Lemah Creek Clinical Research | Burr Ridge | Illinois | United States | 60527 |
| 43 | Cedar-Crosse Research Center | Chicago | Illinois | United States | 60607 |
| 44 | Apex Medical Research | Chicago | Illinois | United States | 60616 |
| 45 | Koch Family Medicine | Morton | Illinois | United States | 61550 |
| 46 | Community Hospital of Anderson and Madison County, Inc | Anderson | Indiana | United States | 46011 |
| 47 | American Health Network - Avon Clinical Research Department | Avon | Indiana | United States | 46103 |
| 48 | Medisphere Medical Research Center | Evansville | Indiana | United States | 47714 |
| 49 | Midwest Institute for Clinical Research | Indianapolis | Indiana | United States | 46260 |
| 50 | Buynak Clinical Research, P.C. | Valparaiso | Indiana | United States | 46383 |
| 51 | West Broadway Clinic | Council Bluffs | Iowa | United States | 51501 |
| 52 | The Iowa Clinic - Cardiovascular Services | West Des Moines | Iowa | United States | 50266 |
| 53 | Professional Research Network of Kansas, LLC | Wichita | Kansas | United States | 67205 |
| 54 | Kentucky Diabetes Endocrinology Center | Lexington | Kentucky | United States | 40503 |
| 55 | The Research Group of Lexington, LLC | Lexington | Kentucky | United States | 40503 |
| 56 | Research Integrity LLC | Owensboro | Kentucky | United States | 42303 |
| 57 | Clinical Trials Management, LLC - Northshore | Covington | Louisiana | United States | 70443 |
| 58 | Clinical Trials Management LLC - Southshore | Metairie | Louisiana | United States | 70006 |
| 59 | Grace Research, LLC | Shreveport | Louisiana | United States | 71105 |
| 60 | Clinical Trials of America, LLC | West Monroe | Louisiana | United States | 71291 |
| 61 | Maryland Cardiovascular Specialists | Baltimore | Maryland | United States | 21229 |
| 62 | Regeneris Medical | North Attleboro | Massachusetts | United States | 2760 |
| 63 | Aa Mrc, Llc | Flint | Michigan | United States | 48504 |
| 64 | Oakland Medical Research Center | Troy | Michigan | United States | 48085 |
| 65 | David M. Headley, MD P.A. | Port Gibson | Mississippi | United States | 39150 |
| 66 | Consult and Research Associates | Saint Louis | Missouri | United States | 63122 |
| 67 | Advance Clinical Research, Inc | Saint Louis | Missouri | United States | 63128 |
| 68 | Glacier View Research Institute | Kalispell | Montana | United States | 59901 |
| 69 | Desert Endocrinology Clinical Research Center | Henderson | Nevada | United States | 89052 |
| 70 | Palm Research Center, Inc. | Las Vegas | Nevada | United States | 89148 |
| 71 | Lovelace Scientific Resources | Albuquerque | New Mexico | United States | 87108 |
| 72 | Lakeshore Primary Care Associate | Hamburg | New York | United States | 14075 |
| 73 | Mid-Hudson Medical Research, PLLC - Hopewell Junction | New Windsor | New York | United States | 12553 |
| 74 | Mid-Hudson Medical Research, PLLC - New Windsor | New Windsor | New York | United States | 12553 |
| 75 | Orchard Park Family Practice | Orchard Park | New York | United States | 14127 |
| 76 | Diabetes and Endocrinology Consultants, P.C. | Morehead City | North Carolina | United States | 28557 |
| 77 | Lillestol Research, LLC | Fargo | North Dakota | United States | 58103 |
| 78 | Sterling Research Group, Ltd. - Auburn | Cincinnati | Ohio | United States | 45219 |
| 79 | Aventiv Research, Inc. | Columbus | Ohio | United States | 43213 |
| 80 | Alpha Research Associates, LLC | Dayton | Ohio | United States | 45417 |
| 81 | Prestige Clinical Research | Franklin | Ohio | United States | 45005 |
| 82 | Ohio Clinical Research - Lyndhurst | Lyndhurst | Ohio | United States | 44124 |
| 83 | Rama Research LLC | Marion | Ohio | United States | 43302 |
| 84 | RAS Health Ltd | Marion | Ohio | United States | 43302 |
| 85 | Summit Research Group, LLC | Munroe Falls | Ohio | United States | 44626 |
| 86 | Ohio Clinical Research, LLC - Willoughby Hills | Willoughby Hills | Ohio | United States | 44094 |
| 87 | COR Clinical Research, LLC. | Oklahoma City | Oklahoma | United States | 73107 |
| 88 | South Oklahoma Heart Research | Oklahoma City | Oklahoma | United States | 73135 |
| 89 | Clinical Research Associates of Central PA, LLC | Altoona | Pennsylvania | United States | 16602 |
| 90 | Harleysville Medical Associates | Harleysville | Pennsylvania | United States | 19438 |
| 91 | Richard M.Kastelic MD and Associates | Johnstown | Pennsylvania | United States | 15905 |
| 92 | Green and Seidner Family Practice Associates | Lansdale | Pennsylvania | United States | 19446 |
| 93 | Center for Medical Research, LLC | Providence | Rhode Island | United States | 2908 |
| 94 | MD First Research | Anderson | South Carolina | United States | 29625 |
| 95 | MDFirst Research - Anderson | Anderson | South Carolina | United States | 29625 |
| 96 | DeGarmo Institute Of Medical Research | Greer | South Carolina | United States | 29650 |
| 97 | MD First Research | Lancaster | South Carolina | United States | 29720 |
| 98 | Family Medicine of SayeBrook | Myrtle Beach | South Carolina | United States | 29588 |
| 99 | Health Concepts | Rapid City | South Dakota | United States | 57702 |
| 100 | PMG Research of Bristol, LLC - State | Bristol | Tennessee | United States | 37620 |
| 101 | Chattanooga Research & Medicine, PLLC | Chattanooga | Tennessee | United States | 37404 |
| 102 | Holston Medical Group | Kingsport | Tennessee | United States | 37660 |
| 103 | New Phase Research & Development | Knoxville | Tennessee | United States | 37909 |
| 104 | Clinical Research Solutions - Smyrna, TN | Smyrna | Tennessee | United States | 37167 |
| 105 | Health Innovation Research Group | Arlington | Texas | United States | 76014 |
| 106 | DCT-AACT, LLC, dba Discovery Clinical Trials | Austin | Texas | United States | 78758 |
| 107 | Inquest Clinical Research | Baytown | Texas | United States | 77521 |
| 108 | Padre Coast Clinical Research | Corpus Christi | Texas | United States | 78404 |
| 109 | Protenium Clinical Research, LLC - Dallas | Dallas | Texas | United States | 75208 |
| 110 | VA North Texas Health Care System - Dallas VA Medical Center (DVAMC) | Dallas | Texas | United States | 75216 |
| 111 | Academy of Diabetes, Thyroid and Endocrine, P.A. | El Paso | Texas | United States | 79935 |
| 112 | Juno Research, LLC | Houston | Texas | United States | 77040 |
| 113 | Centex Studies, Inc. | Houston | Texas | United States | 77058 |
| 114 | Juno Research, LLC | Houston | Texas | United States | 77074 |
| 115 | Pioneer Research Solutions Inc. | Houston | Texas | United States | 77099 |
| 116 | Grace Research, LLC | Huntsville | Texas | United States | 77340 |
| 117 | Protenium Clinical Research, LLC | Hurst | Texas | United States | 76054 |
| 118 | Juno Research, LLC | Katy | Texas | United States | 77450 |
| 119 | FMC Science | Lampasas | Texas | United States | 76550 |
| 120 | Pinnacle Clinical Research | Live Oak | Texas | United States | 78233 |
| 121 | DCT - McAllen Primary Care, LLC | McAllen | Texas | United States | 78503 |
| 122 | San Antonio Premier Internal Medicine | San Antonio | Texas | United States | 78220 |
| 123 | Physician PrimeCare Research Institute, PLLC dba Health Texas Research Institute | San Antonio | Texas | United States | 78228 |
| 124 | Bandera Family HealthCare Research, LLC (BFHC) | San Antonio | Texas | United States | 78249 |
| 125 | Manassas Clinical Research Center | Manassas | Virginia | United States | 20110 |
| 126 | York Clinical Research LLC | Norfolk | Virginia | United States | 23501 |
| 127 | Cardiovascular Associates, Ltd | Virginia Beach | Virginia | United States | 23454 |
| 128 | Exemplar Research Inc. - Fairmont, WV | Morgantown | West Virginia | United States | 26505 |
| 129 | Allegiance Research Specialists, LLC | Wauwatosa | Wisconsin | United States | 53226 |
| 130 | Brest Regional Hospital | Brest | Belarus | 224027 | |
| 131 | Gomel Regional Clinical Hospital | Gomel | Belarus | 246029 | |
| 132 | Gomel Regional Clinical Center of Cardiology | Gomel | Belarus | 246046 | |
| 133 | Grodno University Hospital | Grodno | Belarus | 230030 | |
| 134 | City Clinical Hospital #1 | Minsk | Belarus | 220013 | |
| 135 | City Clinical Hospital #9 | Minsk | Belarus | 220045 | |
| 136 | Minsk Scientific and Practice Center of Surgery, Transplantology and Hematology | Minsk | Belarus | 220045 | |
| 137 | City Clinical Hospital #10 | Minsk | Belarus | 220096 | |
| 138 | Minsk Regional Clinical Hospital | Minsk | Belarus | 223041 | |
| 139 | Mogilev Regional Medical and Diagnostic Center | Mogilev | Belarus | 212030 | |
| 140 | Vitebsk Regional Clinical Hospital | Vitebsk | Belarus | 210037 | |
| 141 | Medical Center Diamedical 2013 OOD | Dimitrovgrad | Bulgaria | 6400 | |
| 142 | University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD- First Cardiology Clinic | Pleven | Bulgaria | 5800 | |
| 143 | University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD- Second Cardiology Clinic | Pleven | Bulgaria | 5800 | |
| 144 | University Multiprofile Hospital for Active Treatment (UMHAT) Sveti Georgi, EAD - Clinic of Cardiology | Plovdiv | Bulgaria | 4002 | |
| 145 | MHAT Dr. Bratan Shukjerov | Smolyan | Bulgaria | 4700 | |
| 146 | Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD | Smolyan | Bulgaria | 4700 | |
| 147 | Fifth Multiprofile Hospital for Active Treatment - Sofia EAD - Department of Cardiology | Sofia | Bulgaria | 1233 | |
| 148 | Fifth Multiprofile Hospital for Active Treatment - Sofia EAD - Department of Endocrinology and Meteorism Diseases | Sofia | Bulgaria | 1233 | |
| 149 | Medical Center Orfey OOD | Stara Zagora | Bulgaria | 6000 | |
| 150 | Medicus Services SRO | Brandýs nad Labem | Czechia | 250 01 | |
| 151 | Lipidova poradna | Bílina | Czechia | 41801 | |
| 152 | Fakultni nemocnice Hradec Kralove, Klinika gerontologicka a metabolicka | Hradec Králové | Czechia | 500 05 | |
| 153 | Ordinace pro choroby srdce a cev | Praha 10 | Czechia | 101 00 | |
| 154 | Vseobecna fakultni nemocnice v Praze | Praha 2 | Czechia | 128 08 | |
| 155 | Fakultni nemocnice v Motole | Praha 5 | Czechia | 15006 | |
| 156 | Oblastni nemocnice Trutnov, Oddeleni klinicke biochemie | Trutnov | Czechia | 541 21 | |
| 157 | MUDr. Nina Zemkova s.r.o. Interni Ambulance | Uherské Hradište | Czechia | 68601 | |
| 158 | Unimed Ajara LLC | Batumi | Georgia | 6010 | |
| 159 | Clinic LJ Ltd | Kutaisi | Georgia | 4600 | |
| 160 | Aleksandre Aladashvili Clinic - LLC | Tbilisi | Georgia | 102 | |
| 161 | Archangel St Michael Multiprofile Clinical Hospital Ltd | Tbilisi | Georgia | 159 | |
| 162 | Emergency Cardiology Center by Academician G. Chapidze Ltd | Tbilisi | Georgia | 159 | |
| 163 | Institute of Clinical Cardiology Ltd | Tbilisi | Georgia | 159 | |
| 164 | Unimed Kakheti - Caraps Medline LLC | Tbilisi | Georgia | 159 | |
| 165 | Unimed Kakheti - Telavi Referral Hospital LLC | Telavi | Georgia | 2200 | |
| 166 | DRC Gyogyszervizsgalo Kozpont Kft | Balatonfüred | Hungary | H-8230 | |
| 167 | DRC Balatongyorok | Balatongyörök | Hungary | H-8313 | |
| 168 | Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly | Budapest | Hungary | 1062 | |
| 169 | Magyar Honvedseg Egeszsegugyi Kozpont | Budapest | Hungary | 1134 | |
| 170 | Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo | Békéscsaba | Hungary | 5600 | |
| 171 | Debreceni Egyetem Klinikai Kozpont | Debrecen | Hungary | H-4032 | |
| 172 | BKS Research Kft. | Hatvan | Hungary | 3000 | |
| 173 | Pecsi Tudomanyegyetem Klinikai Kozpont I.sz. Belgyogyaszati Klinika | Pécs | Hungary | 7624 | |
| 174 | Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz | Székesfehérvár | Hungary | 8000 | |
| 175 | Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii, lek. med. Krzysztof Cymerman | Gdynia | Poland | 81-157 | |
| 176 | SALVIA Lekston i Madej s.j. | Katowice | Poland | 40-772 | |
| 177 | Malopolskie Centrum Alergii i Immunoterapii Allmedis SP Z O O | Krakow | Poland | 31-534 | |
| 178 | MEDICOME Sp. z o.o. | Oświęcim | Poland | 32-600 | |
| 179 | Centrum Zdrowia Metabolicznego Pawel Bogdanski | Poznań | Poland | 60-589 | |
| 180 | Praktyka Lekarska Ewa Krzyzagorska | Poznań | Poland | 61-655 | |
| 181 | Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne OMEGA SP Z O O | Płock | Poland | 09-400 | |
| 182 | Clinmedica Research Omc Sp z o.o. Sp | Skierniewice | Poland | 96-100 | |
| 183 | Centrum Kardiologiczne Pro Corde Sp. z o. o. | Wrocław | Poland | 50-315 | |
| 184 | AppleTreeClinics Sp. z o.o. | Łódź | Poland | 90-349 | |
| 185 | Nzoz Salusmed | Łódź | Poland | 91 302 | |
| 186 | NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek | Łódź | Poland | 94-048 | |
| 187 | Northern Medical Clinical Center named after N.A. Semashko of the Federal Medical and Biological Agency | Arkhangelsk | Russian Federation | 163000 | |
| 188 | First City Clinical Hospital n.a. E.E.Volosevich | Arkhangelsk | Russian Federation | 163001 | |
| 189 | Altay Regional Cardiology Dispensary, Cardiology Department for Patients with Acute Myocardial Infarction | Barnaul | Russian Federation | 656055 | |
| 190 | Chita State Medical Academy | Chita | Russian Federation | 672000 | |
| 191 | Ural State Medical University based at Central City Clinical Hospital No.1 of Oktyabrskiy District | Ekaterinburg | Russian Federation | 620028 | |
| 192 | Interregional Clinical Diagnostic Center | Kazan | Russian Federation | 420101 | |
| 193 | Kazan State Medical University based at City Clinical Hospital #7 | Kazan | Russian Federation | 420103 | |
| 194 | Federal State Budget Institution "Scientific-Research Institute of Complex Problems of Cardiovascular Diseases | Kemerovo | Russian Federation | 650002 | |
| 195 | Medical Center Alliance | Kirovsk | Russian Federation | 187342 | |
| 196 | Krasnoyarsk State Medical University n.a. prof. V.F. Voino-Yasenetsky | Krasnoyarsk | Russian Federation | 660062 | |
| 197 | National Medical Research Center of Preventive Medicine | Moscow | Russian Federation | 101990 | |
| 198 | City Clinical Hospital #15 n.a. O.M. Filatov | Moscow | Russian Federation | 111539 | |
| 199 | Central Clinical Hospital of Russian Academy of Sciences | Moscow | Russian Federation | 117593 | |
| 200 | City Clinical Hospital n.a. M.E. Zhadkevich of Moscow Healthcare Department | Moscow | Russian Federation | 121374 | |
| 201 | National Medical Research Center of Cardiology - Department of Atherosclerosis | Moscow | Russian Federation | 121552 | |
| 202 | National Medical Research Center of Cardiology | Moscow | Russian Federation | 121552 | |
| 203 | City Clinical Hospital n.a. M.P. Konchalovskiy | Moscow | Russian Federation | 124489 | |
| 204 | Non-governmental Private Healthcare Institution "Scientific Clinical Centre of Open Joint-Stock Company Russian Railways" (JSC "RZD") | Moscow | Russian Federation | 125315 | |
| 205 | Federal State Budget Institution "Outpatient Clinic #3" of Russian Federation President's Management Department | Moscow | Russian Federation | 129090 | |
| 206 | City Clinical Hospital No.2 | Novosibirsk | Russian Federation | 630051 | |
| 207 | RC Medical LLC | Novosibirsk | Russian Federation | 630091 | |
| 208 | Research Institute of Physiology and Fundamental Medicine | Novosibirsk | Russian Federation | 630117 | |
| 209 | Orenburg State Medical University based at City Clinical Hospital #1 | Orenburg | Russian Federation | 460000 | |
| 210 | Clinical-diagnostic center Zdorovye | Rostov-on-Don | Russian Federation | 344011 | |
| 211 | Rostov-on-Don City Hospital of Emergency Care | Rostov-on-Don | Russian Federation | 344068 | |
| 212 | Clinic Complex JSC | Saint Petersburg | Russian Federation | 190013 | |
| 213 | North-Western State Medical University named after I.I. Mechnikov | Saint Petersburg | Russian Federation | 191015 | |
| 214 | Medical Technologies LLC | Saint Petersburg | Russian Federation | 191025 | |
| 215 | Limited Liability Company MedPomosch | Saint Petersburg | Russian Federation | 194356 | |
| 216 | City hospital #38 n.a. N.A. Semashko | Saint Petersburg | Russian Federation | 196601 | |
| 217 | BioTechService LLC | Saint Petersburg | Russian Federation | 197022 | |
| 218 | Consultative Diagnostic Center with Out-patient Clinic | Saint Petersburg | Russian Federation | 197110 | |
| 219 | Almazov National Medical Research Centre, Scientific Laboratory of Electrocardiology | Saint Petersburg | Russian Federation | 197341 | |
| 220 | Saint-Petersburg State Budget Healthcare Institution "City Pokrovskaya Hospital", Department of Cardiology N.3 | Saint Petersburg | Russian Federation | 199106 | |
| 221 | Regional Clinical Cardiology Dispensary | Saratov | Russian Federation | 410028 | |
| 222 | Saratov State Medical University n. a. V.I. Razumovsky | Saratov | Russian Federation | 410054 | |
| 223 | Almazov National Medical Research Centre | St. Petersburg | Russian Federation | 194156 | |
| 224 | Clinical Hospital #122 n. a. L.G. Sokolov of the Federal Medical Biological Agency | St. Petersburg | Russian Federation | 194291 | |
| 225 | Tomsk National Research Medical Center of Russian Academy of Sciences | Tomsk | Russian Federation | 634012 | |
| 226 | Autonomous Institution of healthcare of the Voronezh region "Voronezh regional clinical consultative and diagnostic centre | Voronezh | Russian Federation | 394018 | |
| 227 | Yaroslavl Regional Clinical Hospital for War Veterans - International Center on the Problems of the Elderly "Zdorovoe Dolgoletie" | Yaroslavl | Russian Federation | 150047 | |
| 228 | Ivano-Frankivsk Regional Clinical Cardiological Dispensary, Chronic Ischaemic Heart Disease Department | Ivano-Frankivs'k | Ukraine | 76018 | |
| 229 | Municipal Healthcare Institution Kharkiv City Clinical Hospital #27, Intensive Therapy Department | Kharkiv | Ukraine | 61002 | |
| 230 | Kharkiv Medical Academy of Postgraduate Education | Kharkiv | Ukraine | 61103 | |
| 231 | Kharkiv Railway Clinic. Hosp.#1, Branch Office of "Healthcare Center" of PJSC "Ukr. Railways", Cardiology Depart #2 | Kharkiv | Ukraine | 61103 | |
| 232 | Kharkiv Railway Clinic. Hosp.#1, Branch Office of Healthcare Center of PJSC Ukr. Railways, Cardiology Depart #1 | Kharkiv | Ukraine | 61103 | |
| 233 | Municipal Non-Commercial Enterprise "City Clinical Emergency Hospital n.a. prof. O.I. Meshchaninov of Kharkiv City Council | Kharkiv | Ukraine | 61103 | |
| 234 | Municipal Healthcare Institution Kharkiv City Outpatient Clinic #9, General Practice and Family Medicine Department #1 | Kharkiv | Ukraine | 61172 | |
| 235 | Limited Liability Company Treatment and Diagnostic Center Adonis Plus, Outpatient Department | Kyiv | Ukraine | 2002 | |
| 236 | Kyiv City Clinical Hospital #1, Urgent Cardiology Department | Kyiv | Ukraine | 2091 | |
| 237 | SI Institute of Gerontology n.a. D.F.Chebotarev NAMS of Ukraine, Cardiol. Un. of Clin. Physiology and Int. Organs Path. Dep-t., Gen. Ther.Unit | Kyiv | Ukraine | 4114 | |
| 238 | SI Institute of Gerontology n.a. D.F.Chebotarev NAMS of Ukraine, Cardiol. Un. of Clin. Physiology and Int. Organs Path. Dep-t | Kyiv | Ukraine | 4114 | |
| 239 | Municipal Institution City Clinical Hospital #3 n.a. prof. L.J. Aleinikova, Cardiology Intensive Therapy Department | Odesa | Ukraine | 65014 | |
| 240 | Small Private Enterprise, Medical Centre Puls | Vinnytsya | Ukraine | 21001 | |
| 241 | Municipal Institution City Clinical Hospital #6, Therapeutic Department | Zaporizhzhia | Ukraine | 69035 |
Sponsors and Collaborators
- Kowa Research Institute, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT03011450
Other Study ID Numbers:
- K-877-303
First Posted:
Jan 5, 2017
Last Update Posted:
May 1, 2020
Last Verified:
Apr 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: