Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine
A Randomized, Double-blind, Active-controlled, Multicenter Phase III Trial to Evaluate the Efficacy and Safety of Co-administrated AD-2071 and AD-2073 in Patients With Primary Hypercholesterolemia and Essential Hypertension
1 other identifier
interventional
131
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine 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 Jan 2020
Shorter than P25 for phase_3
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
First Submitted
Initial submission to the registry
November 7, 2019
CompletedFirst Posted
Study publicly available on registry
November 8, 2019
CompletedStudy Start
First participant enrolled
January 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2021
CompletedMay 12, 2021
May 1, 2021
12 months
November 7, 2019
May 10, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Low density lipoprotein cholesterol (LDL-C)
LDL-C change at Week 8 compared AD-2071 + AD-2073 with AD-2073
Baseline, Week 8
Mean sitting systolic blood pressure (MSSBP)
MSSBP change at Week 8 compared AD-2071 + AD-2072 with AD-2071 + AD-2073
Baseline, Week 8
Study Arms (3)
Co-administered of AD-2071 and AD-2073
EXPERIMENTAL48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2073(Telmisartan/Amlodipine)" for 8 weeks.
Co-administered of AD-2071 and AD-2072
ACTIVE COMPARATOR48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2072(Telmisartan)" for 8 weeks.
AD-2073
ACTIVE COMPARATOR48 subjects will be assigned and the subjects will be administered "AD-2073(Telmisartan/Amlodipine)" for 8 weeks.
Interventions
PO, Once daily(QD), 8weeks
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, 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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2019
First Posted
November 8, 2019
Study Start
January 23, 2020
Primary Completion
January 14, 2021
Study Completion
January 14, 2021
Last Updated
May 12, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share