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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

Effects of Ranolazine on Coronary Flow Reserve in Symptomatic Diabetic Patients and CAD

Phase 3
Completed
Conditions
Diabetes, Type I
Diabetes, Type II
Angina
Coronary Artery Disease
Interventions
Drug: Placebo
First Posted Date
2012-12-21
Last Posted Date
2017-07-24
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
47
Registration Number
NCT01754259
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

Long Term Prophylactic Therapy of Congenital Long QT Syndrome Type III (LQT3) With Ranolazine

Phase 2
Conditions
Long QT Syndrome Type 3
Interventions
First Posted Date
2012-11-16
Last Posted Date
2015-03-26
Lead Sponsor
Tel-Aviv Sourasky Medical Center
Target Recruit Count
10
Registration Number
NCT01728025
Locations
🇮🇱

Tel Aviv Medical Center, Tel Aviv, Israel

Ranolazine for the Treatment of Chest Pain in HCM Patients

Phase 4
Completed
Conditions
Hypertrophic Cardiomyopathy
Interventions
First Posted Date
2012-11-06
Last Posted Date
2017-03-03
Lead Sponsor
Duke University
Target Recruit Count
14
Registration Number
NCT01721967
Locations
🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

The Effects of Ranolazine on CPET Parameters in Ischemic Cardiomyopathy Patients (ERIC)

Not Applicable
Terminated
Conditions
Cardiomyopathy
Interventions
First Posted Date
2012-10-12
Last Posted Date
2020-02-18
Lead Sponsor
Cardiovascular Institute of the South Clinical Research Corporation
Target Recruit Count
14
Registration Number
NCT01705509
Locations
🇺🇸

Cardiovascular Institute of the South, Lafayette, Louisiana, United States

A Phase 1 Study to Assess the Effect of Severe Renal Impairment on the Pharmacokinetics, as Well as Safety/Tolerability, of Ranolazine

Phase 1
Terminated
Conditions
Severe Renal Impairment
Interventions
First Posted Date
2012-08-30
Last Posted Date
2012-12-06
Lead Sponsor
Gilead Sciences
Target Recruit Count
4
Registration Number
NCT01675973
Locations
🇺🇸

Clinical Pharmacology of Miami, Miami, Florida, United States

Long-term Efficacy Study of Sodium Channel Blocker in LQT3 Patients

Phase 2
Completed
Conditions
Long QT Syndrome
Interventions
Drug: Placebo
First Posted Date
2012-07-24
Last Posted Date
2022-04-07
Lead Sponsor
University of Rochester
Target Recruit Count
25
Registration Number
NCT01648205
Locations
🇺🇸

University of Rochester, Rochester, New York, United States

Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation

Not Applicable
Terminated
Conditions
Atrial Fibrillation New Onset
Ventricular Tachycardia
Medical Care; Complications, Late Effect of Complications
Hemorrhage
Prolonged QTc Interval
Interventions
Drug: Placebo
First Posted Date
2012-05-03
Last Posted Date
2017-03-23
Lead Sponsor
Northwell Health
Target Recruit Count
54
Registration Number
NCT01590979
Locations
🇺🇸

Staten Island University Hosptial, Staten Island, New York, United States

Evaluation of Exercise Treadmill Test (ETT) Indices in Participants With Cardiovascular Disease

Phase 2
Terminated
Conditions
Atherosclerotic Coronary Vascular Disease
Interventions
First Posted Date
2012-03-23
Last Posted Date
2021-06-18
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
14
Registration Number
NCT01562041
Locations
🇺🇸

Novartis Investigative Site, New York, New York, United States

Safety of Amiodarone and Ranolazine Together in Patients With Angina

Phase 4
Conditions
Chronic Stable Angina
Coronary Artery Disease
Ventricular Tachycardia
Atrial Fibrillation
Interventions
Drug: placebo
First Posted Date
2012-03-20
Last Posted Date
2012-03-21
Lead Sponsor
Cardiovascular Consultants of Nevada
Target Recruit Count
50
Registration Number
NCT01558830
Locations
🇺🇸

Cardiovascular Consultants of Nevada, Las Vegas, Nevada, United States

A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Inadequately Controlled on Metformin Alone

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2012-03-15
Last Posted Date
2014-09-23
Lead Sponsor
Gilead Sciences
Target Recruit Count
442
Registration Number
NCT01555164
Locations
🇺🇸

New Phase Research & Development, Knoxville, Tennessee, United States

🇺🇸

National Research Institute, Los Angeles, California, United States

🇺🇸

Baptist Diabetes Associates, Miami, Florida, United States

and more 139 locations
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