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Phase 3 Study to Evaluate the Efficacy and Safety of Co-administrated AD-2021 and AD-2022

NCT ID: NCT06448962

Last Updated: 2024-06-07

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

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-22

Study Completion Date

2021-11-22

Brief Summary

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The purpose of this study is to Evaluate the Efficacy and Safety of Co-administrated AD-2021 and AD-2022

Detailed Description

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Condition or disease : Primary Hypercholesterolemia and Essential Hypertension Intervention/treatment Drug : AD-2021 Drug : AD-2022 Drug : AD-2021 Placebo Drug : AD-2022 Placebo Phase : Phase 3

Conditions

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Hypertension, Essential Primary Hypercholesterolemia

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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Experimental 1

AD-2021, AD-2022

Group Type EXPERIMENTAL

AD-2021

Intervention Type DRUG

PO, Once daily(QD), 8weeks

AD-2022

Intervention Type DRUG

PO, Once daily(QD), 8weeks

Active Comparator 1

AD-2021, AD-2022 placebo

Group Type ACTIVE_COMPARATOR

AD-2021

Intervention Type DRUG

PO, Once daily(QD), 8weeks

AD-2022 Placebo

Intervention Type DRUG

PO, Once daily(QD), 8weeks

Active Comparator 2

AD-2022, AD-2021 placebo

Group Type ACTIVE_COMPARATOR

AD-2022

Intervention Type DRUG

PO, Once daily(QD), 8weeks

AD-2021 Placebo

Intervention Type DRUG

PO, Once daily(QD), 8weeks

Interventions

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AD-2021

PO, Once daily(QD), 8weeks

Intervention Type DRUG

AD-2022

PO, Once daily(QD), 8weeks

Intervention Type DRUG

AD-2021 Placebo

PO, Once daily(QD), 8weeks

Intervention Type DRUG

AD-2022 Placebo

PO, Once daily(QD), 8weeks

Intervention Type DRUG

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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Seok Min Kang, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Yonsei Cardiovascular Hospital

Locations

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Yonsei Cardiovascular Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AD-202P3

Identifier Type: -

Identifier Source: org_study_id