Clinical Trail to Evaluate the Efficacy and Safety of DWJ1451

NCT ID: NCT04161001

Last Updated: 2019-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

237 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-20

Study Completion Date

2022-02-02

Brief Summary

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* 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 \[ Time Frame: 8 weeks \]

Detailed Description

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Conditions

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Hypertension, Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Amlodpine, Olmesartan, Rosuvastatin, Ezetimibe

co-administration of Olmesartan, Amlodipine and Rosuvastatin, Ezetimibe

Group Type EXPERIMENTAL

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

Intervention Type 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)

Olmesartan, Rosuvastatin, Ezetimibe

co-administration of Olmesartan and Rosuvastatin, Ezetimibe

Group Type PLACEBO_COMPARATOR

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

Intervention Type 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)

Amlodpine, Olmesartan

co-administration of Olmesartan, Amlodipine

Group Type PLACEBO_COMPARATOR

Amlodipine/Olmesartan 10/40mg (Combination drug)

Intervention Type 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)

Interventions

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

Intervention Type DRUG

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

Intervention Type DRUG

Amlodipine/Olmesartan 10/40mg (Combination 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)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* orthostatic hypotension
* History of ventricular tachycardia, atrial fibrillation
* uncontrolled diabetes mellitus
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Daewoong clinical

Role: CONTACT

+82-2-550-8800 ext. 8800

Hyunju Shin

Role: CONTACT

Facility Contacts

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Jongwon Ha

Role: primary

82-02-2228-8448

Other Identifiers

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DW_DWJ1451301

Identifier Type: -

Identifier Source: org_study_id

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