- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03872232
Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan
A Randomized, Double-blind, Active-controlled, Multicenter Phase3 Trial to Evaluate the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan in Patients With Primary Hypercholesterolemia and Essential Hypertension
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This trial is a phase 3 study to evaluate efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan in patients with primary hypercholesterolemia and essential hypertension.
In "Rosuvastatin/Ezetimibe+Telmisartan" treatment group, 60 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan" for 8 weeks.
In "Rosuvastatin/Ezetimibe" treatment group, 60 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe" for 8 weeks.
In "Telmisartan" treatment group, 60 subjects will be assigned and the subjects administer "Telmisartan" for 8 weeks.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed informed consent
- Subjects with hypertension and hyperlipidemia
Exclusion Criteria:
- Patient with known or suspected secondary hypertension
- Other exclusions applied
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ezetimibe/Rosuvastatin and Telmisartan
60 subjects will be assigned and the subjects will be administered "Ezetimibe/Rosuvastatin and Telmisartan" for 8 weeks.
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PO, Once daily(QD), 8weeks
Other Names:
PO, Once daily(QD), 8weeks
Other Names:
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Active Comparator: Ezetimibe/Rosuvastatin
60 subjects will be assigned and the subjects will be administered "Ezetimibe/Rosuvastatin" for 8 weeks.
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PO, Once daily(QD), 8weeks
Other Names:
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Active Comparator: Telmisartan
60 subjects will be assigned and the subjects will be administered "Telmisartan" for 8 weeks.
|
PO, Once daily(QD), 8weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Low density lipoprotein cholesterol (LDL-C)
Time Frame: Baseline, Week 8
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LDL-C change at Week 8 compared to Baseline
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Baseline, Week 8
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Mean sitting systolic blood pressure (MSSBP)
Time Frame: Baseline, Week 8
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MSSBP change at Week 8 compared to Baseline
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Baseline, Week 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean sitting systolic blood pressure (MSSBP)
Time Frame: Baseline, Week 4
|
MSSBP change at Week 4 compared to Baseline
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Baseline, Week 4
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Low density lipoprotein cholesterol (LDL-C)
Time Frame: Baseline, Week 4
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LDL-C change at Week 4 compared to Baseline
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Baseline, Week 4
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Mean sitting diastolic blood pressure (MSDBP)
Time Frame: Baseline, Week 4, Week 8
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MSDBP change at Week 4, 8 compared to Baseline
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Baseline, Week 4, Week 8
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Total Cholesterol (TC)
Time Frame: Baseline, Week 4, Week 8
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TC change at Week 4, 8 compared to Baseline
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Baseline, Week 4, Week 8
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High density lipoprotein cholesterol (HDL-C)
Time Frame: Baseline, Week 4, Week 8
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HDL-C change at Week 4, 8 compared to Baseline
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Baseline, Week 4, Week 8
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Triglyceride (TG)
Time Frame: Baseline, Week 4, Week 8
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TG change at Week 4, 8 compared to Baseline
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Baseline, Week 4, Week 8
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Low density lipoprotein cholesterol/High density lipoprotein cholesterol (LDL-C/HDL-C)
Time Frame: Baseline, Week 4, Week 8
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LDL-C/HDL-C change at Week 4, 8 compared to Baseline
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Baseline, Week 4, Week 8
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Total Cholesterol/High density lipoprotein cholesterol (TC/HDL-C)
Time Frame: Baseline, Week 4, Week 8
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TC/HDL-C change at Week 4,8 compared to Baseline
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Baseline, Week 4, Week 8
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hyo Soo Kim, M.D., Ph.D, Seoul National University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Lipid Metabolism Disorders
- Hyperlipidemias
- Dyslipidemias
- Hypertension
- Hypercholesterolemia
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Rosuvastatin Calcium
- Telmisartan
- Ezetimibe
Other Study ID Numbers
- ROZETEL_RCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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