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

A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy and Safety of Co-administrated AD-2021 and AD-2022 in Patients With Primary Hypercholesterolemia and Essential Hypertension

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06448962
Enrollment
109
Registered
2024-06-07
Start date
2020-10-22
Completion date
2021-11-22
Last updated
2024-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Essential, Primary Hypercholesterolemia

Brief summary

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

Detailed description

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

Interventions

DRUGAD-2021

PO, Once daily(QD), 8weeks

DRUGAD-2022

PO, Once daily(QD), 8weeks

DRUGAD-2021 Placebo

PO, Once daily(QD), 8weeks

DRUGAD-2022 Placebo

PO, Once daily(QD), 8weeks

Sponsors

Addpharma Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Signed informed consent * Subjects with hypertension and hyperlipidemia

Exclusion criteria

* Patient with known or suspected secondary hypertension * Other exclusions applied

Design outcomes

Primary

MeasureTime frameDescription
Low density lipoprotein cholesterol (LDL-C)Baseline, Week 8LDL-C change at Week 8 compared AD-2021 + AD-2022 with AD-2022
Mean sitting systolic blood pressure (MSSBP)Baseline, Week 8MSSBP change at Week 8 compared AD-2021 + AD-2022 with AD-2021

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026