CompletedNCT06448962Updated Jun 7, 2024

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

A Phase 3 interventional study of AD-2021 and AD-2022 in Hypertension, Essential and Primary Hypercholesterolemia, sponsored by Addpharma Inc.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-06-07.

Sponsored by Addpharma Inc. · Phase 3, Interventional, and Treatment

From the registry’s dates

Registered 3 years 7 months after the study started (first participant enrolled Oct 2020, registered Jun 2024).

Phase: Phase 3
Study type: Interventional
Enrollment: 109
Allocation: Randomized
Ages: 19 Years and older
Sex: All

Study summary

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

Read the 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

Conditions studied

Hypertension, Essential
Primary Hypercholesterolemia

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In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 109 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

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Lead sponsor

Addpharma Inc. is the lead sponsor of 56 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Signed informed consent
Subjects with hypertension and hyperlipidemia

Exclusion criteria

Exclusion Criteria:

Patient with known or suspected secondary hypertension
Other exclusions applied

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 109 participants (actual)

Study arms

Experimental
Experimental 1
AD-2021, AD-2022
Drug: AD-2021 · Drug: AD-2022
Active comparator
Active Comparator 1
AD-2021, AD-2022 placebo
Drug: AD-2021 · Drug: AD-2022 Placebo
Active comparator
Active Comparator 2
AD-2022, AD-2021 placebo
Drug: AD-2022 · Drug: AD-2021 Placebo

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

What researchers measure

Primary outcomes

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

Study locations

1 site

Yonsei Cardiovascular Hospital
Seoul, Korea, Republic of

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06448962
Lead sponsor: Addpharma Inc.
Responsible party: Sponsor
First posted: Jun 7, 2024
Start date: Oct 22, 2020
Primary completion: Nov 22, 2021
Completion: Nov 22, 2021
Last update: Jun 7, 2024

Study contacts

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

principal investigator · Yonsei Cardiovascular Hospital

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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