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Clinical Trial Details

Trial ID: L5498
Source ID: NCT01425359
Associated Drug: Ranolazine
Title: Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina
Acronym: TERISA
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01425359/results
Conditions: Angina Pectoris|Coronary Artery Disease|Type 2 Diabetes Mellitus
Interventions: DRUG: Ranolazine|DRUG: Ranolazine placebo
Outcome Measures: Primary: Average Weekly Angina Frequency Over the Last 6 Weeks of Treatment, Average weekly angina frequency was defined as the total number of angina episodes reported during the last 6 weeks of treatment divided by 6 weeks. For subjects who terminated with less than 6 weeks of treatment, frequency was calculated as the total number of angina episodes reported during the treatment period divided by the subject's actual duration of treatment., 6 weeks | Secondary: Average Weekly Frequency of Sublingual Nitroglycerin Use Over the Last 6 Weeks of Treatment, Average weekly frequency of sublingual nitroglycerin use was defined as the total number reported during the last 6 weeks of treatment divided by the duration corresponding to the last 6 weeks of treatment., 6 weeks|Percentage of Weeks Participants Achieved at Least a 50% Reduction in Angina Frequency, For each participant, the percentage of the last 6 weeks on treatment during which the angina frequency was less than or equal to 50% of the baseline average weekly angina frequency was determined., 6 weeks|Percentage of the Last 6 Weeks on Treatment During Which the Angina Frequency Was ≤ 50% of the Baseline Average Weekly Angina Frequency, 6 weeks|Change From Baseline in the Short-Form 36® (SF-36) Mental and Physical Component Scores, The range of each health domain score is 0-100, with 0 indicating a poorer health state and 100 indicating a better health state. An increase in score indicates an improvement in health state. Participants were asked to complete the survey at randomization (prior to receiving treatment), and at end of treatment visit (Week 8) or early study drug discontinuation or early termination visit. The survey asked participants for responses specific to the preceding 4 weeks prior to completing the survey., Up to 8 weeks|Patient's Global Impression of Change (PGIC) Scale Score, The PGIC was completed at the end of treatment/last visit.The PGIC scale measures the change in the participant's overall status since the beginning of the study on a scale ranging from 1 (no change or worse) to 7 (very much improved)., 8 weeks
Sponsor/Collaborators: Sponsor: Gilead Sciences
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 949
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2011-09
Completion Date: 2012-10
Results First Posted: 2014-11-04
Last Update Posted: 2014-11-04
Locations: Cardiology and Medicine Clinic, Little Rock, Arkansas, 72204, United States|Merced Heart Associates, Merced, California, 95340, United States|Spectrum Clinical Research Institute, Inc, Moreno Valley, California, 92553, United States|Sacramento Heart and Vascular Research Center, Sacramento, California, 95825, United States|South Florida Research Solutions, LLC, Hollywood, Florida, 33021, United States|Baptist Heart Specialist, Jacksonville, Florida, 32207, United States|Clinical Research of Central Florida, Winter Haven, Florida, 33880, United States|Masters of Clinical Research, Inc., Augusta, Georgia, 30909, United States|Columbus Cardiology Associates, Columbus, Georgia, 31909, United States|Central Cardiology Associates, Elizabethtown, Kentucky, 42701, United States|Research Integrity, LLC, Owensboro, Kentucky, 42303, United States|Alexandria Cardiology Clinic, Alexandria, Louisiana, 71301, United States|Clinical Trials Management, LLC, Mandeville, Louisiana, 70471, United States|Endeavor Medical Research, PLC, Alpena, Michigan, 49707, United States|Minneapolis Heart Institute Foundation, Minneapolis, Minnesota, 55407, United States|Cross Country Cardiology, Edgewater, New Jersey, 07020, United States|Kore CV Research, Jackson, Tennessee, 38305, United States|Wellmont Cardiovascular Associates Heart Institute, Johnson City, Tennessee, 37604, United States|Med-Tech Research, Houston, Texas, 77024, United States|Humble Cardiology Associates, Humble, Texas, 77338, United States|State Institution "Gomel regional clinical hospital", Gomel, 246029, Belarus|State Inst Rep Scientific and Practical center, Minsk, 220036, Belarus|Diagnostic Consultative Center, Ascendent Cardiological Out-Patient Office, Sofia, 1202, Bulgaria|MHAT "Tsar Boris III", Sofia, 1233, Bulgaria|National Cardiology Center, Cardiology Clinic - III, Sofia, 1309, Bulgaria|MHAT "Vita", Cardiology Department, Sofia, 1505, Bulgaria|UMHAT "Tsaritsa Yoanna" - ISUL, Cardiology Clinic, Sofia, 1527, Bulgaria|Military Medical Academy, Clinic of Cardiology and Intesive Care, Sofia, 1606, Bulgaria|SKDS Research Inc, New Market, Ontario, L3Y 5G8, Canada|Dr. Roger Labonté Professional Medicine Corp., Sudbury, Ontario, P3E 3B8, Canada|Aniol Gupta MD, Toronto, Ontario, M9V 4B4, Canada|Montréal General Hospital, Montreal, Quebec, H3G 1A4, Canada|High Desert Medical Group, Lancaster, 93534, Canada|Montreal Heart Institute, Montreal, H1T 1C8, Canada|London Road Diagnostic Clinic and Medical Centre, Ontario, N7T 4X3, Canada|Topsail Road Medical Clinic, Saint John's, A1E 2E2, Canada|Vojenska Nemocnice Brno, Brno, 636 00, Czech Republic|Cardiocentrum Kladno s.r.o., Kladno, 27280, Czech Republic|Poliklinika Modrany - Kardiologie, Praha 4, 14300, Czech Republic|Fakultní Nemocnice v Motole, Praha 5, 150 06, Czech Republic|Corintez s.r.o., Praha 5, 158 00, Czech Republic|Centrum klinického výzkumu, s.r.o., Príbram, 26101, Czech Republic|Nemocnice Slaný, Slaný, 27401, Czech Republic|Tbilisi State Medical University Alexandre Aladashvili University Clinic, Tbilisi, 0102, Georgia|Amtel Hospital First Clinical LLC, Tbilisi, 0144, Georgia|Clinic "Guli", Tbilisi, 0144, Georgia|Cardio-Reanimation Clinic LTD, Tbilisi, 0159, Georgia|Emergency Cardiology Center by Academician G. Chapidze LTD, Tbilisi, 0159, Georgia|Tbilisi Heart and Vascular Clinic LTD, Tbilisi, 0159, Georgia|Multiprofile Clinical Hospital of Tbilisi #2 LTD, Tbilisi, 0164, Georgia|Charité Campus Virchow Klinikum, Berlin, 13353, Germany|Städtische Kliniken Bielefeld, Bielefeld, 33604, Germany|Sankt Johannes-Hospital Dortmund, Dortmund, 44137, Germany|Universitätsklinikum Göttingen, Göttingen, 37099, Germany|Gemeinschaftspraxis fur Kardiologie, Heidelberg, 69115, Germany|Praxis Fur Innere Medizin Kardiologie, Pneumologic und Allergologie, Mannheim, 68165, Germany|Universitätsmedizin Mannheim, Mannheim, 68169, Germany|Barzilai Medical Center, Cardiology Dept., Ashkelon, 78287, Israel|Assaf Harofeh Medical Centre, Be'er Ya'aqov, 70300, Israel|Shaare Zedek Medical Center, Jerusalem, 91004, Israel|Kaplan Medical Center, Rehovot, 76100, Israel|Ziv Medical Center, Safed, 13100, Israel|Tel Aviv Souraski Medical Center, Tel Aviv, 64239, Israel|MULTI-MED PLUS Sp. z o.o., Lódz, Lodzkie, 90-553, Poland|Niepubliczny Zakład Opieki Zdrowotnej Przychodnia Zdrowia "Zadębie", Skierniewice, Lodzkie, 96-100, Poland|KO-MED Marek Konieczny, Puławy, Lubelskie, 24-100, Poland|Specjalistyczna Praktyka Lekarska Leszek Bryniarski, Kraków, Malopolskie, 30-082, Poland|NZOZ Revita Poradnia Kardiologiczna, Kraków, Malopolskie, 31-949, Poland|Instytut Kardiologii, Warszawa, Mazowieckie, 02-637, Poland|Instytut Kardiologii, Warszawa, Mazowieckie, 04-628, Poland|NZOZ Sródmiescie Sp z o.o., Gdynia, Pomorskie, 81-394, Poland|Pomorskie Centra Kardiologiczne S.A., Gdansk, 80126, Poland|S.P. Specjalistyczny Szpital Zachodni im.JP II, Grodzisk, Mazowiecki, 05-825, Poland|Krakowski Szpital Specjalistyczny im.JPII, Krakow, 31-202, Poland|Synexus SCM Sp. z o.o. Oddział w Warszawie, Warszawa, 01-192, Poland|Centrum Badawcze Współczenej Terapii, Warszawa, 02-679, Poland|Slaskie Centrum Chorób Serca w Zabrzu, Zabrze, 41-800, Poland|City Hospital #38 named after Semashko N.A, Pushkin, St. Petersburg, 196601, Russian Federation|Altay Regional Cardiologycal Dispensary, Barnaul, 656055, Russian Federation|"Chita State Medical Academy" Curative-Diagnostic Clinic department, Chita, 672039, Russian Federation|Sverdlovsky Regional Clinical Hospital of Wars Veterans, Ekaterinburg, 620905, Russian Federation|Municipal Institution of Healthcare "Kemerovo Cardiology Dispensary", Kemerovo, 650002, Russian Federation|Non-state Institution of healthcare "Department hospital on station Kemerovo of OAO "Russian Railway", Kemerovo, 650056, Russian Federation|Medical centre "Delis", LLC, Kirovsk, 187342, Russian Federation|Federal State Institution "National Research Center for Preventive Medicine", Moscow, 101990, Russian Federation|State healthcare institution of Moscow "City Clinical hospital#15 named after O.M.Filatov", Moscow, 111539, Russian Federation|State Healthcare institution of Moscow"Cardiology Dispensary #2", Moscow, 117556, Russian Federation|First Moscow State Medical University I.M. Sechenov, Moscow, 119991, Russian Federation|State Budget Educational Institution of High Professional Education First Moscow State Medical University... #1, Cardiology Clinic, Hospital Therapy Department, Moscow, 119991, Russian Federation|State Budget Educational Institution of High Professional Education First Moscow State Medical University... #1, Cardiology Clinic, Hospital Therapy Department, Moscow, 119992, Russian Federation|Moscow City Clinical Hospital #51, Moscow, 121309, Russian Federation|FGU Central Clinical Hospital with Polyclinic of President Administrative Department of RF, Moscow, 121359, Russian Federation|Moscow State University of Medicine and Dentistry based on Moscow City Clinical Hospital #71, Moscow, 121374, Russian Federation|City Clinical Hospital named after S.P.Botkin, Moscow, 125284, Russian Federation|State Institution of Moscow Healthcare "City Clinical Hospital named after S.P. Botkin", Moscow, 125284, Russian Federation|Moscow State Institution of Health "City Clinical Hospital #81", Moscow, 127644, Russian Federation|Federal State Institution "Outpatient department #3" of President Management department of Russian Federation, Moscow, 129090, Russian Federation|State Novosibirsk Regional Clinical Hospital, Novosibirsk, 630087, Russian Federation|Regional Clinical Hospital named after N.N.Burdenko, Penza, 440026, Russian Federation|State Institution of Healthcare Perm Regional Hospital for War Veterans, Perm, 614097, Russian Federation|State Healthcare Institution "Ryazan regional clinical cardiological dispensary", Ryazan, 390026, Russian Federation|"Clinical hospital named after S.R.Mirotvortsev", Saratov, 410054, Russian Federation|Educational Institution of Higher Vocational Education "Smolensk State Medical Academy" on the base of Municipal Medicoprophylactic Institution "Hospital of Emergency Medical Care",, Smolensk, 214000, Russian Federation|FGU Central Clinical Hospital with Polyclinic of President Administrative Department of RF, St. Petersburg, 121359, Russian Federation|Federal State Educational Institution of High Professional Education "Military Medical Academy n.a. S.M. Kirov" of the Ministry of Defence of Russia, St. Petersburg, 191124, Russian Federation|International Medical Center "SOGAZ", LLC, St. Petersburg, 191186, Russian Federation|State Healthcare institution "Municipal Out-patient Clinic #109", St. Petersburg, 192288, Russian Federation|Saint-Petersburg State Healthcare Institution, St. Petersburg, 193144, Russian Federation|Federal Heart, Blood and Endocrinology Centre n.a. Almazov, St. Petersburg, 194156, Russian Federation|Institution and Address: "Medical Research Institute", LLC, St. Petersburg, 196084, Russian Federation|Federal Heart, Blood and Endocrinology Centre n.a. Almazov, St. Petersburg, 197341, Russian Federation|State Institution of Healthcare "City Hospital #40 of Kurortniy administrative district, St. Petersburg, 197705, Russian Federation|Autonomous healthcare institution of Voronezh region "Voronezh regional clinic consultative and diagnostic centre", Voronezh, 394018, Russian Federation|Municipal Institution of Healthcare "Clinical Hospital #8 of Yaroslavl", Yaroslavl, 150030, Russian Federation|Cardiology Clinic, Clinical Center Serbia, Belgrade, 11000, Serbia|Institute of Cardiovascular Diseases, Sremska Kamenica, 21204, Serbia|ALIAN, s.r.o., Bardejov, 085 01, Slovakia|Cardioconsult, s.r.o., Bratislava, 811 04, Slovakia|Kardiovaskulárne centrum, s.r.o., Bratislava, 831 01, Slovakia|CARDIO D&R, s.r.o., Košice, 040 22, Slovakia|KARDIOMED, s.r.o., Lučenec, 984 01, Slovakia|Kardiocentrum Nitra, s.r.o., Nitra, 949 01, Slovakia|University Clinic of Respiratory and Allergic Diseases Golnik, Golnik, 4204, Slovenia|University Klinicni Center Ljubljana, Ljubljana, 1000, Slovenia|General Hospital Murska Sobota, Murska Sobota, 9001, Slovenia|Donetsk National Medical University, Department of Internal Medicine #1 based on Department of Emergency Cardiology and Rehabilitation of Institute of Urgent and Recovery Surgery named after V. K. Gusak, Donetsk, 83045, Ukraine|Central Clinical Hospital of Ukrzaliznitsia, Cardiology department, Kharkiv, 61103, Ukraine|Kharkiv Medical Academy of Postgraduate Education, Department of cardiology and functional diagnostics based on City Clinical Hospital #8, Department of Cardiology #2, Kharkiv, 61176, Ukraine|Central polyclinic of Pechersk district, Department of cardiology, Kyiv, 01103, Ukraine|Kyiv City Clinical Hospital #1, Department of Emergency Cardiology, Kyiv, 02091, Ukraine|Kyiv city clinical hospital #5, Kyiv, 03115, Ukraine|Department of Diabetology of National Medical Academy of Postgraduate Education named after P.L.Shupyk based on Day Time Hospital of Administration of Medical Service and Rehabilitation of "ARTEM" SHC, Kyiv, 04050, Ukraine|SI "Institute of Gerontology of AMS of Ukraine", Kyiv, 04114, Ukraine|Lviv National Medical University named after Danylo Halytsky, Department of Propaedeutics of Internal Medicine #1 based on Polyclinic Department of Municipal City Clinical Hospital #5, Lviv, 79044, Ukraine|SI Odessa Regional Cardiological Dispensary, Odessa, 65025, Ukraine
URL: https://clinicaltrials.gov/show/NCT01425359

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D064 Ranolazine small molecule DB00243 Details