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Ranolazine

Generic Name
Ranolazine
Brand Names
Aspruzyo Sprinkle, Ranexa, Ranexa (previously Latixa)
Drug Type
Small Molecule
Chemical Formula
C24H33N3O4
CAS Number
95635-55-5
Unique Ingredient Identifier
A6IEZ5M406
Background

Chronic angina is a common cardiovascular condition affecting millions worldwide and causes significant disability while interfering with daily activities. Ranolazine is a well-tolerated piperazine derivative used for the management of this condition, offering relief from uncomfortable and debilitating symptoms. With a mechanism of action different from drugs used to treat the same condition, ranolazine is a promising anti-anginal therapy. It was originally approved by the FDA in 2006.

Indication

Ranolazine is indicated for the treatment of chronic angina. It can be used alone or in conjunction with nitrates, beta-blockers, angiotensin receptor blockers, anti-platelet drugs, calcium channel blockers, lipid-lowering drugs, and ACE inhibitors.

Ranolazine has also been used off-label for the treatment of certain arrhythmias, including ventricular tachycardia, however, this use is not strongly supported by scientific evidence. Ranolazine has also been studied for the treatment of acute coronary syndrome, microvascular coronary dysfunction, arrhythmia, and glycemic control, which are not yet approved indications.

Associated Conditions
Chronic Angina, Ventricular Arrhythmia

Single Cohort, 2-Period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine 500 mg

Phase 1
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2012-03-07
Last Posted Date
2012-07-11
Lead Sponsor
Gilead Sciences
Target Recruit Count
25
Registration Number
NCT01546558
Locations
🇺🇸

SeaView Research Inc., Miami, Florida, United States

Single Cohort 4-period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine

Phase 1
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2012-03-07
Last Posted Date
2012-07-11
Lead Sponsor
Gilead Sciences
Target Recruit Count
24
Registration Number
NCT01546597
Locations
🇺🇸

Cetero Research, San Antonio, Texas, United States

Ranolazine in Atrial Fibrillation Following An ELectricaL CardiOversion

Phase 2
Completed
Conditions
Persistent Atrial Fibrillation
Interventions
Drug: Placebo
First Posted Date
2012-02-17
Last Posted Date
2014-08-19
Lead Sponsor
Menarini Group
Target Recruit Count
241
Registration Number
NCT01534962
Locations
🇩🇪

Universitätsmedizin Göttingen (UMG), Kardiologie und Pneumologie, Goettingen, Lower Saxony, Germany

🇮🇹

FONDAZIONE IRCCS, Dip. Cardiotoracovascolare (U.C.C.), Pavia, Lombardy, Italy

🇪🇸

Hospital Clínic i Provincial de Barcelona, Servicio de Cardiología-Sección de Arritmias, Barcelona, Catalonia, Spain

and more 1 locations

Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation

Phase 2
Completed
Conditions
Atrial Fibrillation
Interventions
First Posted Date
2012-01-31
Last Posted Date
2020-11-06
Lead Sponsor
Gilead Sciences
Target Recruit Count
134
Registration Number
NCT01522651
Locations
🇬🇧

Investigational Site, London, England, United Kingdom

The Effects of Ranolazine on Exercise Capacity in Patients With Heart Failure With Preserved Ejection Fraction

Not Applicable
Completed
Conditions
Heart Failure With Preserved Ejection Fraction
Interventions
Drug: Placebo
First Posted Date
2012-01-06
Last Posted Date
2020-01-18
Lead Sponsor
University of California, San Diego
Target Recruit Count
10
Registration Number
NCT01505179
Locations
🇺🇸

University of California, San Diego, San Diego, California, United States

Ranolazine for Improving Symptoms of Palpitations

Phase 4
Conditions
Ischemic Heart Disease
Interventions
Drug: Placebo
First Posted Date
2011-12-20
Last Posted Date
2013-03-07
Lead Sponsor
University of Roma La Sapienza
Target Recruit Count
100
Registration Number
NCT01495520

Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: Placebo
Behavioral: Diet
Behavioral: Exercise
First Posted Date
2011-12-19
Last Posted Date
2014-11-18
Lead Sponsor
Gilead Sciences
Target Recruit Count
431
Registration Number
NCT01494987
Locations
🇺🇸

Clinical Research Advantage/Desert Clinical Research, LLC, Mesa, Arizona, United States

🇺🇸

Desert Sun Clinical Research, LLC, Tucson, Arizona, United States

🇺🇸

Southland Clinical Research Center, Inc., Fountain Valley, California, United States

and more 136 locations

Ranolazine Loading to Prevent PCI-induced Myocardial Injury

Phase 4
Conditions
Coronary Artery Disease
Interventions
Drug: Placebo
First Posted Date
2011-12-13
Last Posted Date
2013-03-07
Lead Sponsor
University of Roma La Sapienza
Target Recruit Count
100
Registration Number
NCT01491061
Locations
🇮🇹

San Raffaele Pisana, Rome, Italy

Pharmacodynamic Effects of Ranolazine Versus Amlodipine on Platelet Reactivity

Phase 4
Conditions
Coronary Artery Disease
Interventions
First Posted Date
2011-12-12
Last Posted Date
2014-03-26
Lead Sponsor
University of Roma La Sapienza
Target Recruit Count
100
Registration Number
NCT01490255
Locations
🇮🇹

San Raffaele Pisana, Rome, Italy

🇮🇹

University La Sapienza, Rome, Italy

Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: Placebo
Behavioral: Diet
Behavioral: Exercise
First Posted Date
2011-11-16
Last Posted Date
2014-10-24
Lead Sponsor
Gilead Sciences
Target Recruit Count
465
Registration Number
NCT01472185
Locations
🇺🇸

Thunderbird Internal Medicine/Clinical Research Advantage, Glendale, Arizona, United States

🇺🇸

North Central Arkansas Medical Associates, Mountain Home, Arkansas, United States

🇺🇸

Desert Sun Clinical Research, LLC, Tucson, Arizona, United States

and more 154 locations
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