Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine

NCT ID: NCT04158076

Last Updated: 2021-05-12

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

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-23

Study Completion Date

2021-01-14

Brief Summary

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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.

Detailed Description

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This trial is a phase 3 study to evaluate efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine in patients with primary hypercholesterolemia and essential hypertension.

In "Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine" treatment group, 48 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine" for 8 weeks.

In "Rosuvastatin/Ezetimibe +Telmisartan " treatment group, 48 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan" for 8 weeks.

In "Telmisartan/Amlodipine" treatment group, 48 subjects will be assigned and the subjects administer "Telmisartan/Amlodipine" for 8 weeks.

Conditions

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Hypercholesterolemia Hypertension

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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Co-administered of AD-2071 and AD-2073

48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2073(Telmisartan/Amlodipine)" for 8 weeks.

Group Type EXPERIMENTAL

Ezetimibe/Rosuvastatin

Intervention Type DRUG

PO, Once daily(QD), 8weeks

Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET

Intervention Type DRUG

PO, Once daily(QD), 8weeks

Co-administered of AD-2071 and AD-2072

48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2072(Telmisartan)" for 8 weeks.

Group Type ACTIVE_COMPARATOR

Ezetimibe/Rosuvastatin

Intervention Type DRUG

PO, Once daily(QD), 8weeks

Telmisartan

Intervention Type DRUG

PO, Once daily(QD), 8weeks

AD-2073

48 subjects will be assigned and the subjects will be administered "AD-2073(Telmisartan/Amlodipine)" for 8 weeks.

Group Type ACTIVE_COMPARATOR

Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET

Intervention Type DRUG

PO, Once daily(QD), 8weeks

Interventions

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Ezetimibe/Rosuvastatin

PO, Once daily(QD), 8weeks

Intervention Type DRUG

Telmisartan

PO, Once daily(QD), 8weeks

Intervention Type DRUG

Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET

PO, Once daily(QD), 8weeks

Intervention Type DRUG

Other Intervention Names

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Rosuvamibe Tab. Micardis Tab. Twynsta

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* Subjects with hypertension and hyperlipidemia

Exclusion Criteria

* Patient with known or suspected secondary hypertension
* Other exclusions applied
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Addpharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hyo Soo Kim, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ROZETELA RCT

Identifier Type: -

Identifier Source: org_study_id

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