NCT04161001

Brief Summary

  • the change of sitSBP based on baseline between Treatment arm and control 1 arm \[ Time Frame: 8 weeks \]
  • the change of LDL-C based on baseline between Treatment arm and control2 arm \[ Time Frame: 8 weeks \]

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
237

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

November 20, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2022

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

2 years

First QC Date

November 7, 2019

Last Update Submit

November 10, 2019

Conditions

Hypertension, Dyslipidemia

Outcome Measures

Primary Outcomes (2)

  • the change of MSSBP based on baseline between Treatment arm and control 1 arm

    8 weeks

  • the change of LDL-C based on baseline between Treatment arm and control2 arm

    8 weeks

Study Arms (3)

Amlodpine, Olmesartan, Rosuvastatin, Ezetimibe

EXPERIMENTAL

co-administration of Olmesartan, Amlodipine and Rosuvastatin, Ezetimibe

Drug: Amlodipine/Olmesartan 10/40mg (Combination drug), Ezetimibe/Rosuvastatin 10/20mg(Combination drug)

Olmesartan, Rosuvastatin, Ezetimibe

PLACEBO COMPARATOR

co-administration of Olmesartan and Rosuvastatin, Ezetimibe

Drug: Olmesartan 40mg, Ezetimibe/Rosuvastatin 10/20mg(Combination drug)

Amlodpine, Olmesartan

PLACEBO COMPARATOR

co-administration of Olmesartan, Amlodipine

Drug: Amlodipine/Olmesartan 10/40mg (Combination drug)

Interventions

Amlodipine/Olmesartan 10/40mg (Combination drug), Ezetimibe/Rosuvastatin 10/20mg(Combination drug)DRUG

co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg), Rosuzet Tab. 10/20mg(Ezetimibe/Rosuvastatin 10/20mg) and placebo of Olmetec Tab. 40mg(Olmesartan 40mg)

Amlodpine, Olmesartan, Rosuvastatin, Ezetimibe
Olmesartan 40mg, Ezetimibe/Rosuvastatin 10/20mg(Combination drug)DRUG

co-administration of Olmetec tab. 40mg(Olmesartan 40mg), Rosuzet Tab. 10/20mg(Ezetimibe/Rosuvastatin 10/20mg) and placebo of Sevikar tab. 10/40mg (Amlodipine/Olmesartan 10/40mg)

Olmesartan, Rosuvastatin, Ezetimibe
Amlodipine/Olmesartan 10/40mg (Combination drug)DRUG

co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg, and placebo of Rosuzet Tab. 10/20mg(Ezetimibe/Rosuvastatin 10/20mg), Olmetec Tab. 40mg(Olmesartan 40mg)

Amlodpine, Olmesartan

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 19 to 80 years
  • patients with hypertension and hyperlipidemias

You may not qualify if:

  • orthostatic hypotension
  • History of ventricular tachycardia, atrial fibrillation
  • uncontrolled diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

HypertensionDyslipidemias

Interventions

AmlodipineolmesartanDrug CombinationsEzetimibeRosuvastatin Calcium

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPharmaceutical PreparationsAzetidinesAzetinesSulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidines

Central Study Contacts

Daewoong clinical

CONTACT

+82-2-550-8800shj@daewoong.co.kr

Hyunju Shin

CONTACT

shj@daewoong.co.kr

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 13, 2019

Study Start

November 20, 2019

Primary Completion

November 20, 2021

Study Completion

February 2, 2022

Last Updated

November 13, 2019

Record last verified: 2019-11

Locations

KR(1)