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Angina PectorisPhase 4TERISANCT01425359

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

A Phase 4 study testing Ranolazine in people with Angina Pectoris and Coronary Artery Disease, run by Gilead Sciences at 135 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ranolazine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
949 participants
Where
135 sitesin 14 countries
Study dates
Sep 2011to Oct 2012
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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.

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

135 sites in 14 countries.

135 sites in 14 countries

Russia37 sites

  • Altay Regional Cardiologycal Dispensary

    Barnaul, 656055

  • "Chita State Medical Academy" Curative-Diagnostic Clinic department

    Chita, 672039

  • Municipal Institution of Healthcare "Kemerovo Cardiology Dispensary"

    Kemerovo, 650002

  • Non-state Institution of healthcare "Department hospital on station Kemerovo of OAO "Russian Railway"

    Kemerovo, 650056

  • Medical centre "Delis", LLC

    Kirovsk, 187342

  • Federal State Institution "National Research Center for Preventive Medicine"

    Moscow, 101990

  • State healthcare institution of Moscow "City Clinical hospital#15 named after O.M.Filatov"

    Moscow, 111539

  • State Healthcare institution of Moscow"Cardiology Dispensary #2"

    Moscow, 117556

  • First Moscow State Medical University I.M. Sechenov

    Moscow, 119991

  • State Budget Educational Institution of High Professional Education First Moscow State Medical University... #1, Cardiology Clinic, Hospital Therapy Department

    Moscow, 119991

  • State Budget Educational Institution of High Professional Education First Moscow State Medical University... #1, Cardiology Clinic, Hospital Therapy Department

    Moscow, 119992

  • Moscow City Clinical Hospital #51

    Moscow, 121309

  • FGU Central Clinical Hospital with Polyclinic of President Administrative Department of RF

    Moscow, 121359

  • Moscow State University of Medicine and Dentistry based on Moscow City Clinical Hospital #71

    Moscow, 121374

  • City Clinical Hospital named after S.P.Botkin

    Moscow, 125284

  • State Institution of Moscow Healthcare "City Clinical Hospital named after S.P. Botkin"

    Moscow, 125284

  • Moscow State Institution of Health "City Clinical Hospital #81"

    Moscow, 127644

  • Federal State Institution "Outpatient department #3" of President Management department of Russian Federation

    Moscow, 129090

  • State Novosibirsk Regional Clinical Hospital

    Novosibirsk, 630087

  • Regional Clinical Hospital named after N.N.Burdenko

    Penza, 440026

  • State Institution of Healthcare Perm Regional Hospital for War Veterans

    Perm, 614097

  • City Hospital #38 named after Semashko N.A

    Pushkin, Sankt-Peterburg, 196601

  • State Healthcare Institution "Ryazan regional clinical cardiological dispensary"

    Ryazan, 390026

  • FGU Central Clinical Hospital with Polyclinic of President Administrative Department of RF

    Saint Petersburg, 121359

  • Federal State Educational Institution of High Professional Education "Military Medical Academy n.a. S.M. Kirov" of the Ministry of Defence of Russia

    Saint Petersburg, 191124

  • International Medical Center "SOGAZ", LLC

    Saint Petersburg, 191186

  • State Healthcare institution "Municipal Out-patient Clinic #109"

    Saint Petersburg, 192288

  • Saint-Petersburg State Healthcare Institution

    Saint Petersburg, 193144

  • Federal Heart, Blood and Endocrinology Centre n.a. Almazov

    Saint Petersburg, 194156

  • Institution and Address: "Medical Research Institute", LLC

    Saint Petersburg, 196084

  • Federal Heart, Blood and Endocrinology Centre n.a. Almazov

    Saint Petersburg, 197341

  • State Institution of Healthcare "City Hospital #40 of Kurortniy administrative district

    Saint Petersburg, 197705

  • "Clinical hospital named after S.R.Mirotvortsev"

    Saratov, 410054

  • Educational Institution of Higher Vocational Education "Smolensk State Medical Academy" on the base of Municipal Medicoprophylactic Institution "Hospital of Emergency Medical Care",

    Smolensk, 214000

  • Autonomous healthcare institution of Voronezh region "Voronezh regional clinic consultative and diagnostic centre"

    Voronezh, 394018

  • Municipal Institution of Healthcare "Clinical Hospital #8 of Yaroslavl"

    Yaroslavl, 150030

  • Sverdlovsky Regional Clinical Hospital of Wars Veterans

    Yekaterinburg, 620905

Other trials in Russia

United States20 sites

  • Alexandria Cardiology Clinic

    Alexandria, Louisiana, 71301

  • Endeavor Medical Research, PLC

    Alpena, Michigan, 49707

  • Masters of Clinical Research, Inc.

    Augusta, Georgia, 30909

  • Columbus Cardiology Associates

    Columbus, Georgia, 31909

  • Cross Country Cardiology

    Edgewater, New Jersey, 07020

  • Central Cardiology Associates

    Elizabethtown, Kentucky, 42701

  • South Florida Research Solutions, LLC

    Hollywood, Florida, 33021

  • Med-Tech Research

    Houston, Texas, 77024

  • Humble Cardiology Associates

    Humble, Texas, 77338

  • Kore CV Research

    Jackson, Tennessee, 38305

  • Baptist Heart Specialist

    Jacksonville, Florida, 32207

  • Wellmont Cardiovascular Associates Heart Institute

    Johnson City, Tennessee, 37604

  • Cardiology and Medicine Clinic

    Little Rock, Arkansas, 72204

  • Clinical Trials Management, LLC

    Mandeville, Louisiana, 70471

  • Merced Heart Associates

    Merced, California, 95340

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • Spectrum Clinical Research Institute, Inc

    Moreno Valley, California, 92553

  • Research Integrity, LLC

    Owensboro, Kentucky, 42303

  • Sacramento Heart and Vascular Research Center

    Sacramento, California, 95825

  • Clinical Research of Central Florida

    Winter Haven, Florida, 33880

Other trials in United States

Poland14 sites

  • Pomorskie Centra Kardiologiczne S.A.

    Gdansk, 80126

  • NZOZ Sródmiescie Sp z o.o.

    Gdynia, Pomeranian Voivodeship, 81-394

  • S.P. Specjalistyczny Szpital Zachodni im.JP II

    Grodzisk Mazowiecki, 05-825

  • Specjalistyczna Praktyka Lekarska Leszek Bryniarski

    Krakow, Lesser Poland Voivodeship, 30-082

  • NZOZ Revita Poradnia Kardiologiczna

    Krakow, Lesser Poland Voivodeship, 31-949

  • Krakowski Szpital Specjalistyczny im.JPII

    Krakow, 31-202

  • MULTI-MED PLUS Sp. z o.o.

    Lódz, Łódź Voivodeship, 90-553

  • KO-MED Marek Konieczny

    Puławy, Lublin Voivodeship, 24-100

  • Niepubliczny Zakład Opieki Zdrowotnej Przychodnia Zdrowia "Zadębie"

    Skierniewice, Łódź Voivodeship, 96-100

  • Instytut Kardiologii

    Warsaw, Masovian Voivodeship, 02-637

  • Instytut Kardiologii

    Warsaw, Masovian Voivodeship, 04-628

  • Synexus SCM Sp. z o.o. Oddział w Warszawie

    Warsaw, 01-192

  • Centrum Badawcze Współczenej Terapii

    Warsaw, 02-679

  • Slaskie Centrum Chorób Serca w Zabrzu

    Zabrze, 41-800

Other trials in Poland

Ukraine10 sites

  • 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

  • Central Clinical Hospital of Ukrzaliznitsia, Cardiology department

    Kharkiv, 61103

  • Kharkiv Medical Academy of Postgraduate Education, Department of cardiology and functional diagnostics based on City Clinical Hospital #8, Department of Cardiology #2

    Kharkiv, 61176

  • Central polyclinic of Pechersk district, Department of cardiology

    Kyiv, 01103

  • Kyiv City Clinical Hospital #1, Department of Emergency Cardiology

    Kyiv, 02091

  • Kyiv city clinical hospital #5

    Kyiv, 03115

  • 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

  • SI "Institute of Gerontology of AMS of Ukraine"

    Kyiv, 04114

  • 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

  • SI Odessa Regional Cardiological Dispensary

    Odesa, 65025

Other trials in Ukraine

Canada8 sites

  • Dr. Roger Labonté Professional Medicine Corp.

    Greater Sudbury, Ontario, P3E 3B8

  • High Desert Medical Group

    Lancaster, 93534

  • Montréal General Hospital

    Montreal, Quebec, H3G 1A4

  • Montreal Heart Institute

    Montreal, H1T 1C8

  • SKDS Research Inc

    Newmarket, Ontario, L3Y 5G8

  • London Road Diagnostic Clinic and Medical Centre

    Ontario, N7T 4X3

  • Topsail Road Medical Clinic

    St. John's, A1E 2E2

  • Aniol Gupta MD

    Toronto, Ontario, M9V 4B4

Other trials in Canada

Czechia7 sites

  • Vojenska Nemocnice Brno

    Brno, 636 00

  • Cardiocentrum Kladno s.r.o.

    Kladno, 27280

  • Poliklinika Modrany - Kardiologie

    Prague, 14300

  • Fakultní Nemocnice v Motole

    Prague, 150 06

  • Corintez s.r.o.

    Prague, 158 00

  • Centrum klinického výzkumu, s.r.o.

    Príbram, 26101

  • Nemocnice Slaný

    Slaný, 27401

Other trials in Czechia

Georgia7 sites

  • Tbilisi State Medical University Alexandre Aladashvili University Clinic

    Tbilisi, 0102

  • Amtel Hospital First Clinical LLC

    Tbilisi, 0144

  • Clinic "Guli"

    Tbilisi, 0144

  • Cardio-Reanimation Clinic LTD

    Tbilisi, 0159

  • Emergency Cardiology Center by Academician G. Chapidze LTD

    Tbilisi, 0159

  • Tbilisi Heart and Vascular Clinic LTD

    Tbilisi, 0159

  • Multiprofile Clinical Hospital of Tbilisi #2 LTD

    Tbilisi, 0164

Other trials in Georgia

Germany7 sites

  • Charité Campus Virchow Klinikum

    Berlin, 13353

  • Städtische Kliniken Bielefeld

    Bielefeld, 33604

  • Sankt Johannes-Hospital Dortmund

    Dortmund, 44137

  • Universitätsklinikum Göttingen

    Göttingen, 37099

  • Gemeinschaftspraxis fur Kardiologie

    Heidelberg, 69115

  • Praxis Fur Innere Medizin Kardiologie, Pneumologic und Allergologie

    Mannheim, 68165

  • Universitätsmedizin Mannheim

    Mannheim, 68169

Other trials in Germany

Bulgaria6 sites

  • Diagnostic Consultative Center, Ascendent Cardiological Out-Patient Office

    Sofia, 1202

  • MHAT "Tsar Boris III"

    Sofia, 1233

  • National Cardiology Center, Cardiology Clinic - III

    Sofia, 1309

  • MHAT "Vita", Cardiology Department

    Sofia, 1505

  • UMHAT "Tsaritsa Yoanna" - ISUL, Cardiology Clinic

    Sofia, 1527

  • Military Medical Academy, Clinic of Cardiology and Intesive Care

    Sofia, 1606

Other trials in Bulgaria

Israel6 sites

  • Barzilai Medical Center, Cardiology Dept.

    Ashkelon, 78287

  • Assaf Harofeh Medical Centre

    Be’er Ya‘aqov, 70300

  • Shaare Zedek Medical Center

    Jerusalem, 91004

  • Kaplan Medical Center

    Rehovot, 76100

  • Ziv Medical Center

    Safed, 13100

  • Tel Aviv Souraski Medical Center

    Tel Aviv, 64239

Other trials in Israel

Slovakia6 sites

  • ALIAN, s.r.o.

    Bardejov, 085 01

  • Cardioconsult, s.r.o.

    Bratislava, 811 04

  • Kardiovaskulárne centrum, s.r.o.

    Bratislava, 831 01

  • CARDIO D&R, s.r.o.

    Košice, 040 22

  • KARDIOMED, s.r.o.

    Lučenec, 984 01

  • Kardiocentrum Nitra, s.r.o.

    Nitra, 949 01

Other trials in Slovakia

Slovenia3 sites

  • University Clinic of Respiratory and Allergic Diseases Golnik

    Golnik, 4204

  • University Klinicni Center Ljubljana

    Ljubljana, 1000

  • General Hospital Murska Sobota

    Murska Sobota, 9001

Other trials in Slovenia

Belarus2 sites

  • State Institution "Gomel regional clinical hospital"

    Homyel, 246029

  • State Inst Rep Scientific and Practical center

    Minsk, 220036

Other trials in Belarus

Serbia2 sites

  • Cardiology Clinic, Clinical Center Serbia

    Belgrade, 11000

  • Institute of Cardiovascular Diseases

    Kamenitz, 21204

Other trials in Serbia

About this study

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

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.

Read the 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.

Being tested
Ranolazine, Ranolazine placebo
Keywords
Chronic angina, Angina pectoris, Coronary artery disease, Type 2 Diabetes Mellitus
Medical subject headings
Angina Pectoris, Coronary Artery Disease, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RanolazineDrug

    Also called Ranexa®

  • Ranolazine placeboDrug

Study groups in NCT01425359
Study groupRoleWhat they receive
PlaceboPlacebo comparatorQualifying 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.
Receives: Drug: Ranolazine placebo
RanolazineExperimentalQualifying 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.
Receives: Drug: Ranolazine; Drug: Ranolazine placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 weeks

Secondary outcomes (5)

  1. 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.

    Measured: 6 weeks

  2. 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.

    Measured: 6 weeks

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

    Measured: 6 weeks

  4. 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.

    Measured: Up to 8 weeks

  5. 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).

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionOct 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
949 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01425359
Sponsor's protocol ID
GS-US-259-0133
Acronym
TERISA
Status last verified
Oct 2014
First submitted
24 Aug 2011
Last updated
4 Nov 2014
Data monitoring committee
No

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.

    PubMed 25249560

  • 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.

    PubMed 24978650

  • 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.

    PubMed 23500237

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ranolazine in people with Angina Pectoris and Coronary Artery Disease, run by Gilead Sciences at 135 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 135 sites in Russia, United States, Poland, Ukraine, Canada and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Weekly Angina Frequency Over the Last 6 Weeks of Treatment (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01425359, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2014.

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