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
1 other identifier
interventional
180
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan in patients with primary hypercholesterolemia and essential hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 26, 2019
CompletedFirst Submitted
Initial submission to the registry
March 11, 2019
CompletedFirst Posted
Study publicly available on registry
March 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2020
CompletedJanuary 15, 2021
January 1, 2021
1.5 years
March 11, 2019
January 13, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Low density lipoprotein cholesterol (LDL-C)
LDL-C change at Week 8 compared to Baseline
Baseline, Week 8
Mean sitting systolic blood pressure (MSSBP)
MSSBP change at Week 8 compared to Baseline
Baseline, Week 8
Secondary Outcomes (8)
Mean sitting systolic blood pressure (MSSBP)
Baseline, Week 4
Low density lipoprotein cholesterol (LDL-C)
Baseline, Week 4
Mean sitting diastolic blood pressure (MSDBP)
Baseline, Week 4, Week 8
Total Cholesterol (TC)
Baseline, Week 4, Week 8
High density lipoprotein cholesterol (HDL-C)
Baseline, Week 4, Week 8
- +3 more secondary outcomes
Study Arms (3)
Ezetimibe/Rosuvastatin and Telmisartan
EXPERIMENTAL60 subjects will be assigned and the subjects will be administered "Ezetimibe/Rosuvastatin and Telmisartan" for 8 weeks.
Ezetimibe/Rosuvastatin
ACTIVE COMPARATOR60 subjects will be assigned and the subjects will be administered "Ezetimibe/Rosuvastatin" for 8 weeks.
Telmisartan
ACTIVE COMPARATOR60 subjects will be assigned and the subjects will be administered "Telmisartan" for 8 weeks.
Interventions
PO, Once daily(QD), 8weeks
PO, Once daily(QD), 8weeks
Eligibility Criteria
You may qualify if:
- Signed informed consent
- Subjects with hypertension and hyperlipidemia
You may not qualify if:
- Patient with known or suspected secondary hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Addpharma Inc.lead
Study Sites (1)
Seoul National University Hospital
Seoul, 03080, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyo Soo Kim, M.D., Ph.D
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2019
First Posted
March 13, 2019
Study Start
February 26, 2019
Primary Completion
August 12, 2020
Study Completion
August 12, 2020
Last Updated
January 15, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share