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Sodium Channel Blocker

Ranolazine, Ethnicity and the Metabolic Syndrome (REMS Trial)

Phase 4
Waitlist Available
Led By Narendra Singh, MD
Research Sponsored by Atlanta Heart Specialists, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 6 months
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Approved for 5 Other Conditions

Summary

The purpose of this study is to measure the effect of ranolazine on ETT (exercise treadmill test) exercise duration in four ethnic subgroups with established coronary artery disease and risk factor(s) for the metabolic syndrome: Caucasian, African American, Southeast Asian and East Indian.

Eligible Conditions
  • Coronary Artery Disease
  • Metabolic Syndrome
  • Angina

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Exercise Duration
Secondary study objectives
Angina Pectoris
Pharmaceutical Preparations
HgbA1c
+2 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Active Control
Group I: Standard of CareActive Control1 Intervention
Group II: RanolazineActive Control1 Intervention
Ranolazine in addition to standard of care medical therapy

Find a Location

Who is running the clinical trial?

Atlanta Heart Specialists, LLCLead Sponsor
Gilead SciencesIndustry Sponsor
1,135 Previous Clinical Trials
867,876 Total Patients Enrolled
18 Trials studying Coronary Artery Disease
8,744 Patients Enrolled for Coronary Artery Disease
Narendra Singh, MDPrincipal InvestigatorAtlanta Heart Specialists, LLC
2 Previous Clinical Trials
112 Total Patients Enrolled
~11 spots leftby Dec 2025
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