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Sodium Channel Blocker
Effect of Ranolazine on Activity Level in Patients With Angina After FFR Based Deferred Intervention (REPTAR) (REPTAR Trial)
Phase 4
Waitlist Available
Research Sponsored by Amit Malhotra, MD
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 up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Approved for 5 Other Conditions
Drug Has Already Been Approved
Summary
The post-marketing study is designed to evaluate the activity level and exercise tolerance of patients with deferred percutaneous intervention due to FFR (fractional flow reserve) greater or equal to 0.81 and treatment with Ranolazine versus placebo.
Eligible Conditions
- Angina
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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.
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.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: RanolazineActive Control1 Intervention
At randomization, patients will be started on 500mg of Ranolazine, twice daily for 1 week. After 1 week, the dosage may be increased to 1000mg of Ranolazine, twice daily for 5 weeks.
Group II: PlaceboPlacebo Group1 Intervention
At Randomization, patients will be started on 500mg of a placebo, twice daily for 1 week. After 1 week, the dosage of the placebo may be increased to 1000mg, twice daily for 5 weeks.
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Who is running the clinical trial?
Amit Malhotra, MDLead Sponsor
Gilead SciencesIndustry Sponsor
1,137 Previous Clinical Trials
867,859 Total Patients Enrolled