A Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia

NCT ID: NCT03009487

Last Updated: 2022-01-11

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-04-30

Brief Summary

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A multi-center, randomized, double-blind, phase III clinical trial to evaluate the efficacy and safety of Olmesartan/Amlodipine/Rosuvastatin combination treatment in patients with concomitant hypertension and hyperlipidemia

Detailed Description

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Conditions

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Hypertension Hyperlipidemias

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

co-administration of Olmesartan, Amlodipine and Rosuvastatin

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Olmesartan, Rosuvastatin

co-administration of Olmesartan and Rosuvastatin

Group Type PLACEBO_COMPARATOR

Olmesartan 40 mg, Rosuvastatin 20mg

Intervention Type DRUG

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

Amlodipine, Olmesartan

co-administration of Amlodipine and and Olmesartan

Group Type PLACEBO_COMPARATOR

Amlodipine/Olmesartan 10/40mg (Combination drug)

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DRUG

Olmesartan 40 mg, Rosuvastatin 20mg

co-administration of Olmetec tab. 40mg(Olmesartan 40mg), Crestor tab. 20mg(Rosuvastatin 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) 10/40mg, Placebo of Olmesartan Tab. 40mg and Placebo of Rosuvastatin 20mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 20 to 80 years
* patients with hypertension and hyperlipidemias

Exclusion Criteria

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

20 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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Seoul national university bundang hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DW_DWJ1351003

Identifier Type: -

Identifier Source: org_study_id

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