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

Primary Purpose

Angina Pectoris, Coronary Artery Disease, Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ranolazine
Ranolazine placebo
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angina Pectoris focused on measuring Chronic angina, Angina pectoris, Coronary artery disease, Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiology and Medicine Clinic
  • Merced Heart Associates
  • Spectrum Clinical Research Institute, Inc
  • Sacramento Heart and Vascular Research Center
  • South Florida Research Solutions, LLC
  • Baptist Heart Specialist
  • Clinical Research of Central Florida
  • Masters of Clinical Research, Inc.
  • Columbus Cardiology Associates
  • Central Cardiology Associates
  • Research Integrity, LLC
  • Alexandria Cardiology Clinic
  • Clinical Trials Management, LLC
  • Endeavor Medical Research, PLC
  • Minneapolis Heart Institute Foundation
  • Cross Country Cardiology
  • Kore CV Research
  • Wellmont Cardiovascular Associates Heart Institute
  • Med-Tech Research
  • Humble Cardiology Associates
  • State Institution "Gomel regional clinical hospital"
  • State Inst Rep Scientific and Practical center
  • Diagnostic Consultative Center, Ascendent Cardiological Out-Patient Office
  • MHAT "Tsar Boris III"
  • National Cardiology Center, Cardiology Clinic - III
  • MHAT "Vita", Cardiology Department
  • UMHAT "Tsaritsa Yoanna" - ISUL, Cardiology Clinic
  • Military Medical Academy, Clinic of Cardiology and Intesive Care
  • SKDS Research Inc
  • Dr. Roger Labonté Professional Medicine Corp.
  • Aniol Gupta MD
  • Montréal General Hospital
  • High Desert Medical Group
  • Montreal Heart Institute
  • London Road Diagnostic Clinic and Medical Centre
  • Topsail Road Medical Clinic
  • Vojenska Nemocnice Brno
  • Cardiocentrum Kladno s.r.o.
  • Poliklinika Modrany - Kardiologie
  • Fakultní Nemocnice v Motole
  • Corintez s.r.o.
  • Centrum klinického výzkumu, s.r.o.
  • Nemocnice Slaný
  • Tbilisi State Medical University Alexandre Aladashvili University Clinic
  • Amtel Hospital First Clinical LLC
  • Clinic "Guli"
  • Cardio-Reanimation Clinic LTD
  • Emergency Cardiology Center by Academician G. Chapidze LTD
  • Tbilisi Heart and Vascular Clinic LTD
  • Multiprofile Clinical Hospital of Tbilisi #2 LTD
  • Charité Campus Virchow Klinikum
  • Städtische Kliniken Bielefeld
  • Sankt Johannes-Hospital Dortmund
  • Universitätsklinikum Göttingen
  • Gemeinschaftspraxis fur Kardiologie
  • Praxis Fur Innere Medizin Kardiologie, Pneumologic und Allergologie
  • Universitätsmedizin Mannheim
  • Barzilai Medical Center, Cardiology Dept.
  • Assaf Harofeh Medical Centre
  • Shaare Zedek Medical Center
  • Kaplan Medical Center
  • Ziv Medical Center
  • Tel Aviv Souraski Medical Center
  • MULTI-MED PLUS Sp. z o.o.
  • Niepubliczny Zakład Opieki Zdrowotnej Przychodnia Zdrowia "Zadębie"
  • KO-MED Marek Konieczny
  • Specjalistyczna Praktyka Lekarska Leszek Bryniarski
  • NZOZ Revita Poradnia Kardiologiczna
  • Instytut Kardiologii
  • Instytut Kardiologii
  • NZOZ Sródmiescie Sp z o.o.
  • Pomorskie Centra Kardiologiczne S.A.
  • S.P. Specjalistyczny Szpital Zachodni im.JP II
  • Krakowski Szpital Specjalistyczny im.JPII
  • Synexus SCM Sp. z o.o. Oddział w Warszawie
  • Centrum Badawcze Współczenej Terapii
  • Slaskie Centrum Chorób Serca w Zabrzu
  • City Hospital #38 named after Semashko N.A
  • Altay Regional Cardiologycal Dispensary
  • "Chita State Medical Academy" Curative-Diagnostic Clinic department
  • Sverdlovsky Regional Clinical Hospital of Wars Veterans
  • Municipal Institution of Healthcare "Kemerovo Cardiology Dispensary"
  • Non-state Institution of healthcare "Department hospital on station Kemerovo of OAO "Russian Railway"
  • Medical centre "Delis", LLC
  • Federal State Institution "National Research Center for Preventive Medicine"
  • State healthcare institution of Moscow "City Clinical hospital#15 named after O.M.Filatov"
  • State Healthcare institution of Moscow"Cardiology Dispensary #2"
  • First Moscow State Medical University I.M. Sechenov
  • State Budget Educational Institution of High Professional Education First Moscow State Medical University... #1, Cardiology Clinic, Hospital Therapy Department
  • State Budget Educational Institution of High Professional Education First Moscow State Medical University... #1, Cardiology Clinic, Hospital Therapy Department
  • Moscow City Clinical Hospital #51
  • FGU Central Clinical Hospital with Polyclinic of President Administrative Department of RF
  • Moscow State University of Medicine and Dentistry based on Moscow City Clinical Hospital #71
  • City Clinical Hospital named after S.P.Botkin
  • State Institution of Moscow Healthcare "City Clinical Hospital named after S.P. Botkin"
  • Moscow State Institution of Health "City Clinical Hospital #81"
  • Federal State Institution "Outpatient department #3" of President Management department of Russian Federation
  • State Novosibirsk Regional Clinical Hospital
  • Regional Clinical Hospital named after N.N.Burdenko
  • State Institution of Healthcare Perm Regional Hospital for War Veterans
  • State Healthcare Institution "Ryazan regional clinical cardiological dispensary"
  • "Clinical hospital named after S.R.Mirotvortsev"
  • Educational Institution of Higher Vocational Education "Smolensk State Medical Academy" on the base of Municipal Medicoprophylactic Institution "Hospital of Emergency Medical Care",
  • FGU Central Clinical Hospital with Polyclinic of President Administrative Department of RF
  • Federal State Educational Institution of High Professional Education "Military Medical Academy n.a. S.M. Kirov" of the Ministry of Defence of Russia
  • International Medical Center "SOGAZ", LLC
  • State Healthcare institution "Municipal Out-patient Clinic #109"
  • Saint-Petersburg State Healthcare Institution
  • Federal Heart, Blood and Endocrinology Centre n.a. Almazov
  • Institution and Address: "Medical Research Institute", LLC
  • Federal Heart, Blood and Endocrinology Centre n.a. Almazov
  • State Institution of Healthcare "City Hospital #40 of Kurortniy administrative district
  • Autonomous healthcare institution of Voronezh region "Voronezh regional clinic consultative and diagnostic centre"
  • Municipal Institution of Healthcare "Clinical Hospital #8 of Yaroslavl"
  • Cardiology Clinic, Clinical Center Serbia
  • Institute of Cardiovascular Diseases
  • ALIAN, s.r.o.
  • Cardioconsult, s.r.o.
  • Kardiovaskulárne centrum, s.r.o.
  • CARDIO D&R, s.r.o.
  • KARDIOMED, s.r.o.
  • Kardiocentrum Nitra, s.r.o.
  • University Clinic of Respiratory and Allergic Diseases Golnik
  • University Klinicni Center Ljubljana
  • General Hospital Murska Sobota
  • 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
  • Central Clinical Hospital of Ukrzaliznitsia, Cardiology department
  • Kharkiv Medical Academy of Postgraduate Education, Department of cardiology and functional diagnostics based on City Clinical Hospital #8, Department of Cardiology #2
  • Central polyclinic of Pechersk district, Department of cardiology
  • Kyiv City Clinical Hospital #1, Department of Emergency Cardiology
  • Kyiv city clinical hospital #5
  • 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
  • SI "Institute of Gerontology of AMS of 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
  • SI Odessa Regional Cardiological Dispensary

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Ranolazine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Percentage of the Last 6 Weeks on Treatment During Which the Angina Frequency Was ≤ 50% of the Baseline Average Weekly Angina Frequency
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.
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).

Full Information

First Posted
August 24, 2011
Last Updated
October 30, 2014
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01425359
Brief Title
Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina
Acronym
TERISA
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris, Coronary Artery Disease, Type 2 Diabetes Mellitus
Keywords
Chronic angina, Angina pectoris, Coronary artery disease, Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
949 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Ranolazine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ranolazine
Other Intervention Name(s)
Ranexa®
Intervention Type
Drug
Intervention Name(s)
Ranolazine placebo
Primary Outcome Measure Information:
Title
Average Weekly Angina Frequency Over the Last 6 Weeks of Treatment
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Average Weekly Frequency of Sublingual Nitroglycerin Use Over the Last 6 Weeks of Treatment
Description
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.
Time Frame
6 weeks
Title
Percentage of Weeks Participants Achieved at Least a 50% Reduction in Angina Frequency
Description
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.
Time Frame
6 weeks
Title
Percentage of the Last 6 Weeks on Treatment During Which the Angina Frequency Was ≤ 50% of the Baseline Average Weekly Angina Frequency
Time Frame
6 weeks
Title
Change From Baseline in the Short-Form 36® (SF-36) Mental and Physical Component Scores
Description
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.
Time Frame
Up to 8 weeks
Title
Patient's Global Impression of Change (PGIC) Scale Score
Description
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).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Angiographic evidence of ≥ 50% stenosis of one or more major coronary arteries History of myocardial infarction (MI) documented by positive myocardial muscle creatine kinase (CK-MB) enzymes, troponins, or electrocardiogram (ECG) changes 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Yue, MD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Cardiology and Medicine Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Facility Name
Merced Heart Associates
City
Merced
State/Province
California
ZIP/Postal Code
95340
Country
United States
Facility Name
Spectrum Clinical Research Institute, Inc
City
Moreno Valley
State/Province
California
ZIP/Postal Code
92553
Country
United States
Facility Name
Sacramento Heart and Vascular Research Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
South Florida Research Solutions, LLC
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Baptist Heart Specialist
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Clinical Research of Central Florida
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Masters of Clinical Research, Inc.
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Columbus Cardiology Associates
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Facility Name
Central Cardiology Associates
City
Elizabethtown
State/Province
Kentucky
ZIP/Postal Code
42701
Country
United States
Facility Name
Research Integrity, LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Alexandria Cardiology Clinic
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
Clinical Trials Management, LLC
City
Mandeville
State/Province
Louisiana
ZIP/Postal Code
70471
Country
United States
Facility Name
Endeavor Medical Research, PLC
City
Alpena
State/Province
Michigan
ZIP/Postal Code
49707
Country
United States
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Cross Country Cardiology
City
Edgewater
State/Province
New Jersey
ZIP/Postal Code
07020
Country
United States
Facility Name
Kore CV Research
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Wellmont Cardiovascular Associates Heart Institute
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Med-Tech Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Humble Cardiology Associates
City
Humble
State/Province
Texas
ZIP/Postal Code
77338
Country
United States
Facility Name
State Institution "Gomel regional clinical hospital"
City
Gomel
ZIP/Postal Code
246029
Country
Belarus
Facility Name
State Inst Rep Scientific and Practical center
City
Minsk
ZIP/Postal Code
220036
Country
Belarus
Facility Name
Diagnostic Consultative Center, Ascendent Cardiological Out-Patient Office
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
MHAT "Tsar Boris III"
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
National Cardiology Center, Cardiology Clinic - III
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
MHAT "Vita", Cardiology Department
City
Sofia
ZIP/Postal Code
1505
Country
Bulgaria
Facility Name
UMHAT "Tsaritsa Yoanna" - ISUL, Cardiology Clinic
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Military Medical Academy, Clinic of Cardiology and Intesive Care
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
SKDS Research Inc
City
New Market
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
Dr. Roger Labonté Professional Medicine Corp.
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 3B8
Country
Canada
Facility Name
Aniol Gupta MD
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9V 4B4
Country
Canada
Facility Name
Montréal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
High Desert Medical Group
City
Lancaster
ZIP/Postal Code
93534
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
London Road Diagnostic Clinic and Medical Centre
City
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Topsail Road Medical Clinic
City
Saint John's
ZIP/Postal Code
A1E 2E2
Country
Canada
Facility Name
Vojenska Nemocnice Brno
City
Brno
ZIP/Postal Code
636 00
Country
Czech Republic
Facility Name
Cardiocentrum Kladno s.r.o.
City
Kladno
ZIP/Postal Code
27280
Country
Czech Republic
Facility Name
Poliklinika Modrany - Kardiologie
City
Praha 4
ZIP/Postal Code
14300
Country
Czech Republic
Facility Name
Fakultní Nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czech Republic
Facility Name
Corintez s.r.o.
City
Praha 5
ZIP/Postal Code
158 00
Country
Czech Republic
Facility Name
Centrum klinického výzkumu, s.r.o.
City
Príbram
ZIP/Postal Code
26101
Country
Czech Republic
Facility Name
Nemocnice Slaný
City
Slaný
ZIP/Postal Code
27401
Country
Czech Republic
Facility Name
Tbilisi State Medical University Alexandre Aladashvili University Clinic
City
Tbilisi
ZIP/Postal Code
0102
Country
Georgia
Facility Name
Amtel Hospital First Clinical LLC
City
Tbilisi
ZIP/Postal Code
0144
Country
Georgia
Facility Name
Clinic "Guli"
City
Tbilisi
ZIP/Postal Code
0144
Country
Georgia
Facility Name
Cardio-Reanimation Clinic LTD
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Emergency Cardiology Center by Academician G. Chapidze LTD
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Tbilisi Heart and Vascular Clinic LTD
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Multiprofile Clinical Hospital of Tbilisi #2 LTD
City
Tbilisi
ZIP/Postal Code
0164
Country
Georgia
Facility Name
Charité Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Städtische Kliniken Bielefeld
City
Bielefeld
ZIP/Postal Code
33604
Country
Germany
Facility Name
Sankt Johannes-Hospital Dortmund
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Universitätsklinikum Göttingen
City
Göttingen
ZIP/Postal Code
37099
Country
Germany
Facility Name
Gemeinschaftspraxis fur Kardiologie
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Praxis Fur Innere Medizin Kardiologie, Pneumologic und Allergologie
City
Mannheim
ZIP/Postal Code
68165
Country
Germany
Facility Name
Universitätsmedizin Mannheim
City
Mannheim
ZIP/Postal Code
68169
Country
Germany
Facility Name
Barzilai Medical Center, Cardiology Dept.
City
Ashkelon
ZIP/Postal Code
78287
Country
Israel
Facility Name
Assaf Harofeh Medical Centre
City
Be'er Ya'aqov
ZIP/Postal Code
70300
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91004
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Ziv Medical Center
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Tel Aviv Souraski Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
MULTI-MED PLUS Sp. z o.o.
City
Lódz
State/Province
Lodzkie
ZIP/Postal Code
90-553
Country
Poland
Facility Name
Niepubliczny Zakład Opieki Zdrowotnej Przychodnia Zdrowia "Zadębie"
City
Skierniewice
State/Province
Lodzkie
ZIP/Postal Code
96-100
Country
Poland
Facility Name
KO-MED Marek Konieczny
City
Puławy
State/Province
Lubelskie
ZIP/Postal Code
24-100
Country
Poland
Facility Name
Specjalistyczna Praktyka Lekarska Leszek Bryniarski
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
30-082
Country
Poland
Facility Name
NZOZ Revita Poradnia Kardiologiczna
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
31-949
Country
Poland
Facility Name
Instytut Kardiologii
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-637
Country
Poland
Facility Name
Instytut Kardiologii
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
04-628
Country
Poland
Facility Name
NZOZ Sródmiescie Sp z o.o.
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-394
Country
Poland
Facility Name
Pomorskie Centra Kardiologiczne S.A.
City
Gdansk
ZIP/Postal Code
80126
Country
Poland
Facility Name
S.P. Specjalistyczny Szpital Zachodni im.JP II
City
Grodzisk, Mazowiecki
ZIP/Postal Code
05-825
Country
Poland
Facility Name
Krakowski Szpital Specjalistyczny im.JPII
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Synexus SCM Sp. z o.o. Oddział w Warszawie
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Centrum Badawcze Współczenej Terapii
City
Warszawa
ZIP/Postal Code
02-679
Country
Poland
Facility Name
Slaskie Centrum Chorób Serca w Zabrzu
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
City Hospital #38 named after Semashko N.A
City
Pushkin
State/Province
St. Petersburg
ZIP/Postal Code
196601
Country
Russian Federation
Facility Name
Altay Regional Cardiologycal Dispensary
City
Barnaul
ZIP/Postal Code
656055
Country
Russian Federation
Facility Name
"Chita State Medical Academy" Curative-Diagnostic Clinic department
City
Chita
ZIP/Postal Code
672039
Country
Russian Federation
Facility Name
Sverdlovsky Regional Clinical Hospital of Wars Veterans
City
Ekaterinburg
ZIP/Postal Code
620905
Country
Russian Federation
Facility Name
Municipal Institution of Healthcare "Kemerovo Cardiology Dispensary"
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Non-state Institution of healthcare "Department hospital on station Kemerovo of OAO "Russian Railway"
City
Kemerovo
ZIP/Postal Code
650056
Country
Russian Federation
Facility Name
Medical centre "Delis", LLC
City
Kirovsk
ZIP/Postal Code
187342
Country
Russian Federation
Facility Name
Federal State Institution "National Research Center for Preventive Medicine"
City
Moscow
ZIP/Postal Code
101990
Country
Russian Federation
Facility Name
State healthcare institution of Moscow "City Clinical hospital#15 named after O.M.Filatov"
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
State Healthcare institution of Moscow"Cardiology Dispensary #2"
City
Moscow
ZIP/Postal Code
117556
Country
Russian Federation
Facility Name
First Moscow State Medical University I.M. Sechenov
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
State Budget Educational Institution of High Professional Education First Moscow State Medical University... #1, Cardiology Clinic, Hospital Therapy Department
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
State Budget Educational Institution of High Professional Education First Moscow State Medical University... #1, Cardiology Clinic, Hospital Therapy Department
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
Facility Name
Moscow City Clinical Hospital #51
City
Moscow
ZIP/Postal Code
121309
Country
Russian Federation
Facility Name
FGU Central Clinical Hospital with Polyclinic of President Administrative Department of RF
City
Moscow
ZIP/Postal Code
121359
Country
Russian Federation
Facility Name
Moscow State University of Medicine and Dentistry based on Moscow City Clinical Hospital #71
City
Moscow
ZIP/Postal Code
121374
Country
Russian Federation
Facility Name
City Clinical Hospital named after S.P.Botkin
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
State Institution of Moscow Healthcare "City Clinical Hospital named after S.P. Botkin"
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Moscow State Institution of Health "City Clinical Hospital #81"
City
Moscow
ZIP/Postal Code
127644
Country
Russian Federation
Facility Name
Federal State Institution "Outpatient department #3" of President Management department of Russian Federation
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
Facility Name
State Novosibirsk Regional Clinical Hospital
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
Regional Clinical Hospital named after N.N.Burdenko
City
Penza
ZIP/Postal Code
440026
Country
Russian Federation
Facility Name
State Institution of Healthcare Perm Regional Hospital for War Veterans
City
Perm
ZIP/Postal Code
614097
Country
Russian Federation
Facility Name
State Healthcare Institution "Ryazan regional clinical cardiological dispensary"
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
"Clinical hospital named after S.R.Mirotvortsev"
City
Saratov
ZIP/Postal Code
410054
Country
Russian Federation
Facility Name
Educational Institution of Higher Vocational Education "Smolensk State Medical Academy" on the base of Municipal Medicoprophylactic Institution "Hospital of Emergency Medical Care",
City
Smolensk
ZIP/Postal Code
214000
Country
Russian Federation
Facility Name
FGU Central Clinical Hospital with Polyclinic of President Administrative Department of RF
City
St. Petersburg
ZIP/Postal Code
121359
Country
Russian Federation
Facility Name
Federal State Educational Institution of High Professional Education "Military Medical Academy n.a. S.M. Kirov" of the Ministry of Defence of Russia
City
St. Petersburg
ZIP/Postal Code
191124
Country
Russian Federation
Facility Name
International Medical Center "SOGAZ", LLC
City
St. Petersburg
ZIP/Postal Code
191186
Country
Russian Federation
Facility Name
State Healthcare institution "Municipal Out-patient Clinic #109"
City
St. Petersburg
ZIP/Postal Code
192288
Country
Russian Federation
Facility Name
Saint-Petersburg State Healthcare Institution
City
St. Petersburg
ZIP/Postal Code
193144
Country
Russian Federation
Facility Name
Federal Heart, Blood and Endocrinology Centre n.a. Almazov
City
St. Petersburg
ZIP/Postal Code
194156
Country
Russian Federation
Facility Name
Institution and Address: "Medical Research Institute", LLC
City
St. Petersburg
ZIP/Postal Code
196084
Country
Russian Federation
Facility Name
Federal Heart, Blood and Endocrinology Centre n.a. Almazov
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
State Institution of Healthcare "City Hospital #40 of Kurortniy administrative district
City
St. Petersburg
ZIP/Postal Code
197705
Country
Russian Federation
Facility Name
Autonomous healthcare institution of Voronezh region "Voronezh regional clinic consultative and diagnostic centre"
City
Voronezh
ZIP/Postal Code
394018
Country
Russian Federation
Facility Name
Municipal Institution of Healthcare "Clinical Hospital #8 of Yaroslavl"
City
Yaroslavl
ZIP/Postal Code
150030
Country
Russian Federation
Facility Name
Cardiology Clinic, Clinical Center Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute of Cardiovascular Diseases
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
ALIAN, s.r.o.
City
Bardejov
ZIP/Postal Code
085 01
Country
Slovakia
Facility Name
Cardioconsult, s.r.o.
City
Bratislava
ZIP/Postal Code
811 04
Country
Slovakia
Facility Name
Kardiovaskulárne centrum, s.r.o.
City
Bratislava
ZIP/Postal Code
831 01
Country
Slovakia
Facility Name
CARDIO D&R, s.r.o.
City
Košice
ZIP/Postal Code
040 22
Country
Slovakia
Facility Name
KARDIOMED, s.r.o.
City
Lučenec
ZIP/Postal Code
984 01
Country
Slovakia
Facility Name
Kardiocentrum Nitra, s.r.o.
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
University Clinic of Respiratory and Allergic Diseases Golnik
City
Golnik
ZIP/Postal Code
4204
Country
Slovenia
Facility Name
University Klinicni Center Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
General Hospital Murska Sobota
City
Murska Sobota
ZIP/Postal Code
9001
Country
Slovenia
Facility Name
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
City
Donetsk
ZIP/Postal Code
83045
Country
Ukraine
Facility Name
Central Clinical Hospital of Ukrzaliznitsia, Cardiology department
City
Kharkiv
ZIP/Postal Code
61103
Country
Ukraine
Facility Name
Kharkiv Medical Academy of Postgraduate Education, Department of cardiology and functional diagnostics based on City Clinical Hospital #8, Department of Cardiology #2
City
Kharkiv
ZIP/Postal Code
61176
Country
Ukraine
Facility Name
Central polyclinic of Pechersk district, Department of cardiology
City
Kyiv
ZIP/Postal Code
01103
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital #1, Department of Emergency Cardiology
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Kyiv city clinical hospital #5
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
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
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
SI "Institute of Gerontology of AMS of Ukraine"
City
Kyiv
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
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
City
Lviv
ZIP/Postal Code
79044
Country
Ukraine
Facility Name
SI Odessa Regional Cardiological Dispensary
City
Odessa
ZIP/Postal Code
65025
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
25249560
Citation
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.
Results Reference
derived
PubMed Identifier
24978650
Citation
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.
Results Reference
derived
PubMed Identifier
23500237
Citation
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.
Results Reference
derived

Learn more about this trial

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

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