Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina (TERISA)

A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Parallel Study of Ranolazine in Subjects With Chronic Stable Angina and Coronary Artery Disease With a History of Type 2 Diabetes Mellitus

This study will evaluate the effect of ranolazine compared to placebo on the average weekly angina frequency in subjects with chronic stable angina and coronary artery disease (CAD) who have a history of type 2 diabetes mellitus (T2DM), and whether ranolazine can reduce the frequency of angina (chest pain) attacks, compared to a placebo. Subjects will be asked to record their daily angina episodes in a diary at the end of each study day. Ranolazine is approved for the treatment of chronic angina, and is not approved for the treatment of T2DM.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Type 2 Diabetes Mellitus; Angina Pectoris
• Intervention / Treatment: Drug: Ranolazine; Drug: Ranolazine placebo

Detailed Description

Participants who meet the eligibility criteria at screening will enter a 4-to 6-week Qualifying Period. The allowed concomitant antianginal medication(s) must be maintained at a stable dose throughout the study. Participants will document the number of angina episodes, number of sublingual nitroglycerin doses taken, and a dyspnea score (on a scale from 1 to 5) on a daily basis in a diary. Participants eligible to stay in the study after the Qualifying Period will enter the 8-week double-blind dosing phase. Participants will have study visits at the end of Weeks 2 and 8. Participants will continue to document the number of angina episodes and number of sublingual nitroglycerin doses taken as well as a dyspnea score on a daily basis by the end of each day in their diary. In addition, participants will be called during Week 2 and at the end of Week 5 to encourage compliance. A safety follow-up phone call will be made 14 days after the last study visit or early discontinuation.

• Study Type: Interventional
• Enrollment (Actual): 949
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belarus
  • Gomel, Belarus, 246029
    • State Institution "Gomel regional clinical hospital"
  • Minsk, Belarus, 220036
    • State Inst Rep Scientific and Practical center
• Bulgaria
  • Sofia, Bulgaria, 1202
    • Diagnostic Consultative Center, Ascendent Cardiological Out-Patient Office
  • Sofia, Bulgaria, 1233
    • MHAT "Tsar Boris III"
  • Sofia, Bulgaria, 1309
    • National Cardiology Center, Cardiology Clinic - III
  • Sofia, Bulgaria, 1505
    • MHAT "Vita", Cardiology Department
  • Sofia, Bulgaria, 1527
    • UMHAT "Tsaritsa Yoanna" - ISUL, Cardiology Clinic
  • Sofia, Bulgaria, 1606
    • Military Medical Academy, Clinic of Cardiology and Intesive Care
• Canada
  • Lancaster, Canada, 93534
    • High Desert Medical Group
  • Montreal, Canada, H1T 1C8
    • Montreal Heart Institute
  • Ontario, Canada, N7T 4X3
    • London Road Diagnostic Clinic and Medical Centre
  • Saint John's, Canada, A1E 2E2
    • Topsail Road Medical Clinic
  • Ontario
    • New Market, Ontario, Canada, L3Y 5G8
      • SKDS Research Inc
    • Sudbury, Ontario, Canada, P3E 3B8
      • Dr. Roger Labonté Professional Medicine Corp.
    • Toronto, Ontario, Canada, M9V 4B4
      • Aniol Gupta MD
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • Montreal General Hospital
• Czech Republic
  • Brno, Czech Republic, 636 00
    • Vojenska nemocnice Brno
  • Kladno, Czech Republic, 27280
    • Cardiocentrum Kladno s.r.o.
  • Praha 4, Czech Republic, 14300
    • Poliklinika Modrany - Kardiologie
  • Praha 5, Czech Republic, 150 06
    • Fakultni nemocnice v Motole
  • Praha 5, Czech Republic, 158 00
    • Corintez s.r.o.
  • Príbram, Czech Republic, 26101
    • Centrum klinického výzkumu, s.r.o.
  • Slaný, Czech Republic, 27401
    • Nemocnice Slany
• Georgia
  • Tbilisi, Georgia, 0159
    • Tbilisi Heart and Vascular Clinic Ltd
  • Tbilisi, Georgia, 0144
    • Amtel Hospital First Clinical LLC
  • Tbilisi, Georgia, 0102
    • Tbilisi State Medical University Alexandre Aladashvili University Clinic
  • Tbilisi, Georgia, 0144
    • Clinic "Guli"
  • Tbilisi, Georgia, 0159
    • Cardio-Reanimation Clinic LTD
  • Tbilisi, Georgia, 0159
    • Emergency Cardiology Center by Academician G. Chapidze Ltd
  • Tbilisi, Georgia, 0164
    • Multiprofile Clinical Hospital of Tbilisi #2 LTD
• Germany
  • Berlin, Germany, 13353
    • Charite Campus Virchow Klinikum
  • Bielefeld, Germany, 33604
    • Städtische Kliniken Bielefeld
  • Dortmund, Germany, 44137
    • Sankt Johannes-Hospital Dortmund
  • Göttingen, Germany, 37099
    • Universitätsklinikum Göttingen
  • Heidelberg, Germany, 69115
    • Gemeinschaftspraxis fur Kardiologie
  • Mannheim, Germany, 68169
    • Universitatsmedizin Mannheim
  • Mannheim, Germany, 68165
    • Praxis Fur Innere Medizin Kardiologie, Pneumologic und Allergologie
• Israel
  • Ashkelon, Israel, 78287
    • Barzilai Medical Center, Cardiology Dept.
  • Be'er Ya'aqov, Israel, 70300
    • Assaf Harofeh Medical Centre
  • Jerusalem, Israel, 91004
    • Shaare Zedek Medical Center
  • Rehovot, Israel, 76100
    • Kaplan Medical Center
  • Safed, Israel, 13100
    • Ziv Medical Center
  • Tel Aviv, Israel, 64239
    • Tel Aviv Souraski Medical Center
• Poland
  • Gdansk, Poland, 80126
    • Pomorskie Centra Kardiologiczne S.A.
  • Grodzisk, Mazowiecki, Poland, 05-825
    • S.P. Specjalistyczny Szpital Zachodni im.JP II
  • Krakow, Poland, 31-202
    • Krakowski Szpital Specjalistyczny im.JPII
  • Warszawa, Poland, 01-192
    • Synexus SCM Sp. z o.o. Oddział w Warszawie
  • Warszawa, Poland, 02-679
    • Centrum Badawcze Współczenej Terapii
  • Zabrze, Poland, 41-800
    • Slaskie Centrum Chorob Serca W Zabrzu
  • Lodzkie
    • Lódz, Lodzkie, Poland, 90-553
      • MULTI-MED PLUS Sp. z o.o.
    • Skierniewice, Lodzkie, Poland, 96-100
      • Niepubliczny Zakład Opieki Zdrowotnej Przychodnia Zdrowia "Zadębie"
  • Lubelskie
    • Puławy, Lubelskie, Poland, 24-100
      • KO-MED Marek Konieczny
  • Malopolskie
    • Kraków, Malopolskie, Poland, 30-082
      • Specjalistyczna Praktyka Lekarska Leszek Bryniarski
    • Kraków, Malopolskie, Poland, 31-949
      • NZOZ Revita Poradnia Kardiologiczna
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-637
      • Instytut Kardiologii
    • Warszawa, Mazowieckie, Poland, 04-628
      • Instytut Kardiologii
  • Pomorskie
    • Gdynia, Pomorskie, Poland, 81-394
      • NZOZ Sródmiescie Sp z o.o.
• Russian Federation
  • Barnaul, Russian Federation, 656055
    • Altay Regional Cardiologycal Dispensary
  • Chita, Russian Federation, 672039
    • "Chita State Medical Academy" Curative-Diagnostic Clinic department
  • Ekaterinburg, Russian Federation, 620905
    • Sverdlovsky Regional Clinical Hospital of Wars Veterans
  • Kemerovo, Russian Federation, 650002
    • Municipal Institution of Healthcare "Kemerovo Cardiology Dispensary"
  • Kemerovo, Russian Federation, 650056
    • Non-state Institution of healthcare "Department hospital on station Kemerovo of OAO "Russian Railway"
  • Kirovsk, Russian Federation, 187342
    • Medical centre "Delis", LLC
  • Moscow, Russian Federation, 101990
    • Federal State Institution "National Research Center for Preventive Medicine"
  • Moscow, Russian Federation, 111539
    • State healthcare institution of Moscow "City Clinical hospital#15 named after O.M.Filatov"
  • Moscow, Russian Federation, 117556
    • State Healthcare institution of Moscow"Cardiology Dispensary #2"
  • Moscow, Russian Federation, 119991
    • First Moscow State Medical University I.M. Sechenov
  • Moscow, Russian Federation, 119991
    • State Budget Educational Institution of High Professional Education First Moscow State Medical University... #1, Cardiology Clinic, Hospital Therapy Department
  • Moscow, Russian Federation, 119992
    • State Budget Educational Institution of High Professional Education First Moscow State Medical University... #1, Cardiology Clinic, Hospital Therapy Department
  • Moscow, Russian Federation, 121309
    • Moscow City Clinical Hospital #51
  • Moscow, Russian Federation, 121359
    • FGU Central Clinical Hospital with Polyclinic of President Administrative Department of RF
  • Moscow, Russian Federation, 121374
    • Moscow State University of Medicine and Dentistry based on Moscow City Clinical Hospital #71
  • Moscow, Russian Federation, 125284
    • City Clinical Hospital named after S.P.Botkin
  • Moscow, Russian Federation, 125284
    • State Institution of Moscow Healthcare "City Clinical Hospital named after S.P. Botkin"
  • Moscow, Russian Federation, 127644
    • Moscow State Institution of Health "City Clinical Hospital #81"
  • Moscow, Russian Federation, 129090
    • Federal State Institution "Outpatient department #3" of President Management department of Russian Federation
  • Novosibirsk, Russian Federation, 630087
    • State Novosibirsk Regional Clinical Hospital
  • Penza, Russian Federation, 440026
    • Regional Clinical Hospital named after N.N.Burdenko
  • Perm, Russian Federation, 614097
    • State Institution of Healthcare Perm Regional Hospital for War Veterans
  • Ryazan, Russian Federation, 390026
    • State Healthcare Institution "Ryazan regional clinical cardiological dispensary"
  • Saratov, Russian Federation, 410054
    • "Clinical hospital named after S.R.Mirotvortsev"
  • Smolensk, Russian Federation, 214000
    • Educational Institution of Higher Vocational Education "Smolensk State Medical Academy" on the base of Municipal Medicoprophylactic Institution "Hospital of Emergency Medical Care",
  • St. Petersburg, Russian Federation, 121359
    • FGU Central Clinical Hospital with Polyclinic of President Administrative Department of RF
  • St. Petersburg, Russian Federation, 191124
    • 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, Russian Federation, 191186
    • International Medical Center "SOGAZ", LLC
  • St. Petersburg, Russian Federation, 192288
    • State Healthcare institution "Municipal Out-patient Clinic #109"
  • St. Petersburg, Russian Federation, 193144
    • Saint-Petersburg State Healthcare Institution
  • St. Petersburg, Russian Federation, 194156
    • Federal Heart, Blood and Endocrinology Centre n.a. Almazov
  • St. Petersburg, Russian Federation, 196084
    • Institution and Address: "Medical Research Institute", LLC
  • St. Petersburg, Russian Federation, 197341
    • Federal Heart, Blood and Endocrinology Centre n.a. Almazov
  • St. Petersburg, Russian Federation, 197705
    • State Institution of Healthcare "City Hospital #40 of Kurortniy administrative district
  • Voronezh, Russian Federation, 394018
    • Autonomous healthcare institution of Voronezh region "Voronezh regional clinic consultative and diagnostic centre"
  • Yaroslavl, Russian Federation, 150030
    • Municipal Institution of Healthcare "Clinical Hospital #8 of Yaroslavl"
  • St. Petersburg
    • Pushkin, St. Petersburg, Russian Federation, 196601
      • City Hospital #38 named after Semashko N.A
• Serbia
  • Belgrade, Serbia, 11000
    • Cardiology Clinic, Clinical Center Serbia
  • Sremska Kamenica, Serbia, 21204
    • Institute of Cardiovascular Diseases
• Slovakia
  • Bardejov, Slovakia, 085 01
    • Alian, s.r.o.
  • Bratislava, Slovakia, 811 04
    • CARDIOCONSULT, s.r.o.
  • Bratislava, Slovakia, 831 01
    • Kardiovaskularne centrum, s.r.o.
  • Košice, Slovakia, 040 22
    • CARDIO D&R, s.r.o.
  • Lučenec, Slovakia, 984 01
    • Kardiomed, S.R.O.
  • Nitra, Slovakia, 949 01
    • Kardiocentrum Nitra, s.r.o.
• Slovenia
  • Golnik, Slovenia, 4204
    • University Clinic of Respiratory and Allergic Diseases Golnik
  • Ljubljana, Slovenia, 1000
    • University Klinicni Center Ljubljana
  • Murska Sobota, Slovenia, 9001
    • General Hospital Murska Sobota
• Ukraine
  • Donetsk, Ukraine, 83045
    • 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
  • Kharkiv, Ukraine, 61103
    • Central Clinical Hospital of Ukrzaliznitsia, Cardiology department
  • Kharkiv, Ukraine, 61176
    • Kharkiv Medical Academy of Postgraduate Education, Department of cardiology and functional diagnostics based on City Clinical Hospital #8, Department of Cardiology #2
  • Kyiv, Ukraine, 01103
    • Central polyclinic of Pechersk district, Department of cardiology
  • Kyiv, Ukraine, 02091
    • Kyiv City Clinical Hospital #1, Department of Emergency Cardiology
  • Kyiv, Ukraine, 03115
    • Kyiv city clinical hospital #5
  • Kyiv, Ukraine, 04050
    • 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, Ukraine, 04114
    • SI "Institute of Gerontology of AMS of Ukraine"
  • Lviv, Ukraine, 79044
    • 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
  • Odessa, Ukraine, 65025
    • SI Odessa Regional Cardiological Dispensary
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72204
      • Cardiology and Medicine Clinic
  • California
    • Merced, California, United States, 95340
      • Merced Heart Associates
    • Moreno Valley, California, United States, 92553
      • Spectrum Clinical Research Institute, Inc
    • Sacramento, California, United States, 95825
      • Sacramento Heart and Vascular Research Center
  • Florida
    • Hollywood, Florida, United States, 33021
      • South Florida Research Solutions, LLC
    • Jacksonville, Florida, United States, 32207
      • Baptist Heart Specialist
    • Winter Haven, Florida, United States, 33880
      • Clinical Research of Central Florida
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Masters of Clinical Research, Inc.
    • Columbus, Georgia, United States, 31909
      • Columbus Cardiology Associates
  • Kentucky
    • Elizabethtown, Kentucky, United States, 42701
      • Central Cardiology Associates
    • Owensboro, Kentucky, United States, 42303
      • Research Integrity, LLC
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Alexandria Cardiology Clinic
    • Mandeville, Louisiana, United States, 70471
      • Clinical Trials Management, LLC
  • Michigan
    • Alpena, Michigan, United States, 49707
      • Endeavor Medical Research, Plc
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation
  • New Jersey
    • Edgewater, New Jersey, United States, 07020
      • Cross Country Cardiology
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Kore CV Research
    • Johnson City, Tennessee, United States, 37604
      • Wellmont Cardiovascular Associates Heart Institute
  • Texas
    • Houston, Texas, United States, 77024
      • Med-Tech Research
    • Humble, Texas, United States, 77338
      • Humble Cardiology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent
• Males and females aged at least 18 years
• At least a 3-month history of chronic stable angina triggered by physical effort and relieved by rest and/or sublingual nitroglycerin

• CAD documented by one or more of the following:

  1. Angiographic evidence of ≥ 50% stenosis of one or more major coronary arteries
  2. History of myocardial infarction (MI) documented by positive myocardial muscle creatine kinase (CK-MB) enzymes, troponins, or electrocardiogram (ECG) changes
  3. Cardiac imaging study or exercise test diagnostic for CAD
• Treatment with up to 2 antianginal therapies at a stable dose for at least 2 weeks prior to the Qualifying Period.
• Documented history of T2DM
• Willing to maintain stable tobacco usage habits throughout the study
• Willing to maintain stable activity levels throughout the study
• Females of childbearing potential must agree to utilize highly effective contraception methods from Screening throughout the duration of study treatment and for 14 days following the last dose of study drug.

Exclusion Criteria:

• New York Heart Association (NYHA) Class III and IV
• Acute coronary syndrome in the prior 2 months or planned coronary revascularization during the study period
• Stroke or transient ischemic attack within 6 months prior to Screening
• QTc > 500 milliseconds
• Uncontrolled hypertension (seated systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg)
• Systolic blood pressure < 100 mmHg
• Clinically significant hepatic impairment
• Prior treatment with ranolazine, or known hypersensitivity or intolerance to ranolazine
• Females who are breastfeeding
• Positive serum pregnancy test
• Participation in another investigational drug or device study within 1 month prior to Screening
• Current treatment with trimetazidine, ivabradine, or nicorandil. Subjects will need to discontinue these medications 2 weeks prior to the Qualifying Period.
• Current treatment with potent inhibitors of cytochrome (CYP)3A (eg, ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir)
• Current treatment with CYP3A and P glycoprotein (Pgp) inducers (eg, rifampicin/rifampin, carbamazepine, and St. John's wort [Hypericum perforatum])
• Current treatment with CYP3A4 substrates with a narrow therapeutic range (eg, cyclosporine, tacrolimus, and sirolimus)
• Subjects taking simvastatin who cannot reduce the dose to 20 mg once daily or who cannot switch to another statin
• Current treatment with Class I or III antiarrhythmic medications
• History of illicit drug use or alcohol abuse within 1 year of Screening
• Any other conditions that, in the opinion of the investigator, are likely to prevent compliance with the study protocol or pose a safety concern if the subject participates in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; Qualifying phase: Participants will enter a 2-week washout period if needing to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period will be randomized to the treatment period. Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks.	Drug: Ranolazine placebo
EXPERIMENTAL: Ranolazine; Qualifying phase: Participants will enter a 2-week washout period if needing to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period will be randomized to the treatment period. Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks.	Drug: Ranolazine; Other Names: Ranexa®; Drug: Ranolazine placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Gilead Sciences

Publications and helpful links

General Publications

• Arnold SV, Kosiborod M, Li Y, Jones PG, Yue P, Belardinelli L, Spertus JA. Comparison of the Seattle Angina Questionnaire With Daily Angina Diary in the TERISA Clinical Trial. Circ Cardiovasc Qual Outcomes. 2014 Nov;7(6):844-50. doi: 10.1161/CIRCOUTCOMES.113.000752. Epub 2014 Sep 23.
• Roubinian NH, Escobar GJ, Liu V, Gardner MN, Carson JL, Kleinman SH, Murphy EL; NHLBI Recipient Epidemiology and Donor Evaluation Study (REDS-III). Decreased red blood cell use and mortality in hospitalized patients. JAMA Intern Med. 2014 Aug;174(8):1405-7. doi: 10.1001/jamainternmed.2014.2889. No abstract available.
• Kosiborod M, Arnold SV, Spertus JA, McGuire DK, Li Y, Yue P, Ben-Yehuda O, Katz A, Jones PG, Olmsted A, Belardinelli L, Chaitman BR. Evaluation of ranolazine in patients with type 2 diabetes mellitus and chronic stable angina: results from the TERISA randomized clinical trial (Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina). J Am Coll Cardiol. 2013 May 21;61(20):2038-45. doi: 10.1016/j.jacc.2013.02.011. Epub 2013 Mar 10.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: August 24, 2011
• First Submitted That Met QC Criteria: August 26, 2011
• First Posted (ESTIMATE): August 30, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): November 4, 2014
• Last Update Submitted That Met QC Criteria: October 30, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Coronary artery disease; Angina pectoris; Type 2 Diabetes Mellitus; Chronic angina
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Endocrine System Diseases; Chest Pain; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2; Angina Pectoris; Angina, Stable; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Sodium Channel Blockers; Ranolazine
• Other Study ID Numbers: GS-US-259-0133