Clinical Trial to Evaluate the Efficacy and Safety of Suvaro®OD Tablet in Patients With Dyslipidemia
NCT06153433 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 112
Last updated 2023-12-01
Summary
The aim of study is to evaluate the efficacy and safety of the new generic formulation (rosuvastatin orally disintegrating tablet (SUVARO®ODT) in patients with dyslipidemia.
Conditions
Interventions
- DRUG
-
Rosuvastatin Immediate-Release Tablet (IRT) 10mg
Rosuvastatin Immediate-Release Tablet (IRT) 10mg
- DRUG
-
Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg
Rosuvastatin orally disintegrating tablet (SUVARO®ODT) 10mg
Sponsors & Collaborators
-
Yonsei University
lead OTHER
Principal Investigators
-
Jung-Sun Kim · Division of Cardiology, Department of Internal Medicine, Yonsei Univerisity
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-06
- Primary Completion
- 2024-07-31
- Completion
- 2024-08-31
Countries
- South Korea
Study Locations
More Related Trials
-
Korean Rosuvastatin Effectiveness Study in Nondiabetic Metabolic Syndrome
NCT00335699 ·Status: COMPLETED ·Phase: PHASE4
-
Phase III Study of Rosuvastatin and Fenofibrate Versus Rosuvastatin in Mixed Dyslipidemia
NCT02262143 ·Status: COMPLETED ·Phase: PHASE3
-
PK Study of Telmisartan/Rosuvastatin FDC Compared to Combination of Telmisartan and Rosuvastatin
NCT01975961 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Estimate the Effect of AZD5718 on the Pharmacokinetics (What Does the Body Does to the Drug) of Rosuvastatin to Measure the Relative Bioavailability (the Extent to Which a Drug or Other Substance Becomes Available to the Body) of AZD5718 Oral Suspension vs AZD5718 Immediate Release Tablet
NCT02963116 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy of Low-dose (10 mg) Rosuvastatin in Korean 4 Statin Benefit Groups Per 2013 ACC/AHA Guideline
NCT03903029 ·Status: COMPLETED
-
Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration in Patients With Dyslipidemia in Korea
NCT04829149 ·Status: COMPLETED
-
Study to Evaluate the Drug Interaction Between CKD-519 and Rosuvastatin in Healthy Male Subjects
NCT03175835 ·Status: COMPLETED ·Phase: PHASE1
-
Treatment of Hypercholesterolaemia in South Asian Subjects (IRIS)
NCT00654225 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Investigate the Interaction of GSK1292263 With Rosuvastatin and Simvastatin in Healthy Subjects
NCT01101568 ·Status: COMPLETED ·Phase: PHASE1
-
Tolerability and Efficacy of Rosuvastatin - Fenofibrate Combine Therapy in Korean Patients With Combined Hyperlipidemia
NCT01414803 ·Status: COMPLETED ·Phase: PHASE4
-
Multicenter, Prospective, Non-interventional, Observational Study to Confirm the Long-term Efficacy and Safety of Rosuampin Tab. in Patients With Hypertension and Hypercholesterolemia
NCT06293261 ·Status: COMPLETED
-
Randomized Controlled Trial of Moderate-Intensity Rosuvastatin With Ezetimibe Combination Therapy Versus High-Intensity Rosuvastatin on Progression of Coronary Atherosclerotic Plaque
NCT03169985 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
Compare the Safety & Efficacy of Rosuvastatin 40mg in Combination With Ezetimibe 10mg
NCT00653445 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Compare Rosuvastatin/Ezetimibe and Rosuvastatin in Patients With Diabetes Mellitus and Hypercholesterolemia
NCT03217409 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluation of the Efficacy of Rosuvastatin in Daily Practice (TARGET)
NCT00396110 ·Status: COMPLETED
-
Real-life EValuation Of High Dose RosUvastatin in High Risk Patients After TitraTION
NCT00526721 ·Status: COMPLETED
-
A Clinical Study to Evaluate PK, PD, and PG of Rosuvastatin in the Elderly
NCT03715101 ·Status: COMPLETED ·Phase: PHASE1
-
Study of PF-04965842 Effect on Rosuvastatin Pharmacokinetics in Healthy Participants
NCT03806101 ·Status: COMPLETED ·Phase: PHASE1
-
Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia
NCT00683618 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Endothelial Function
NCT01223625 ·Status: COMPLETED ·Phase: PHASE4
-
The Efficacy and Safety of a Combination Therapy of Rosuvastatin and Ezetimibe Versus Monotherapy of Rosuvastatin in Hypercholesterolemia Patients
NCT02251847 ·Status: UNKNOWN ·Phase: PHASE3
-
A Drug Interaction Study Between Simvastatin, Atorvastatin, Rosuvastatin, and GSK2248761 in Healthy Subjects.
NCT01138072 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Type IIa and IIb Hypercholesterolaemic Patients
NCT00631189 ·Status: COMPLETED ·Phase: PHASE4
-
Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease
NCT00329160 ·Status: COMPLETED ·Phase: PHASE4
-
Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED)
NCT00862251 ·Status: COMPLETED ·Phase: PHASE3