Hypertension, EssentialPhase 3NCT06448962
Phase 3 Study to Evaluate the Efficacy and Safety of Co-administrated AD-2021 and AD-2022
A Phase 3 study testing AD-2021 and AD-2022 in people with Hypertension, Essential and Primary Hypercholesterolemia, run by Addpharma Inc. at 1 site in South Korea.
Trial summary
The purpose of this study is to Evaluate the Efficacy and Safety of Co-administrated AD-2021 and AD-2022 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension, Essential, Primary Hypercholesterolemia
- What is being tested?
- AD-2021 and AD-2022
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Oct 2020to 22 Nov 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Subjects with hypertension and hyperlipidemia
Who cannot join
- Patient with known or suspected secondary hypertension
- Other exclusions applied
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- AD-2021, AD-2022, AD-2021 Placebo, AD-2022 Placebo
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-2021Drug
PO, Once daily(QD), 8weeks
AD-2022Drug
PO, Once daily(QD), 8weeks
AD-2021 PlaceboDrug
PO, Once daily(QD), 8weeks
AD-2022 PlaceboDrug
PO, Once daily(QD), 8weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | AD-2021, AD-2022 Receives: Drug: AD-2021; Drug: AD-2022 |
| Active Comparator 1 | Active comparator | AD-2021, AD-2022 placebo Receives: Drug: AD-2021; Drug: AD-2022 Placebo |
| Active Comparator 2 | Active comparator | AD-2022, AD-2021 placebo Receives: Drug: AD-2022; Drug: AD-2021 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low density lipoprotein cholesterol (LDL-C)
LDL-C change at Week 8 compared AD-2021 + AD-2022 with AD-2022
Measured: Baseline, Week 8
Mean sitting systolic blood pressure (MSSBP)
MSSBP change at Week 8 compared AD-2021 + AD-2022 with AD-2021
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start22 Oct 2020
- Primary completion22 Nov 2021
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, EssentialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addpharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seok Min Kang, M.D., Ph.D, Principal investigator, Yonsei Cardiovascular Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448962
- Sponsor's protocol ID
- AD-202P3
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06448962
- Acronym / sponsor ID
- AD-202P3
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Drug: AD-2021, Drug: AD-2022AD-2021, AD-2022 |
| Active Comparator 1 | Active comparator | Drug: AD-2021, Drug: AD-2022 PlaceboAD-2021, AD-2022 placebo |
| Active Comparator 2 | Active comparator | Drug: AD-2022, Drug: AD-2021 PlaceboAD-2022, AD-2021 placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed informed consent
- Subjects with hypertension and hyperlipidemia
Key exclusion criteria (2 listed)
- Patient with known or suspected secondary hypertension
- Other exclusions applied
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AD-2021PO, Once daily(QD), 8weeks | Drug | Active Comparator 1, Experimental 1 |
| AD-2022PO, Once daily(QD), 8weeks | Drug | Active Comparator 2, Experimental 1 |
| AD-2021 PlaceboPO, Once daily(QD), 8weeks | Drug | Active Comparator 2 |
| AD-2022 PlaceboPO, Once daily(QD), 8weeks | Drug | Active Comparator 1 |
Primary outcome
Low density lipoprotein cholesterol (LDL-C)
Time frame: Baseline, Week 8
LDL-C change at Week 8 compared AD-2021 + AD-2022 with AD-2022
Mean sitting systolic blood pressure (MSSBP)
Time frame: Baseline, Week 8
MSSBP change at Week 8 compared AD-2021 + AD-2022 with AD-2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Hypertension, Essential
Active, not recruitingPhase 1
Safety, Tolerability, PK and PD of ADX-850 in Participants With Hypertension
Hypertension, Hypertension,Essential
Recruiting
Air Pollution and Cardiovascular Disease in Qatar: an Interventional Study to Reduce Blood Pressure
Hypertension, Systolic, Metabolic Syndrome
Recruiting
An Extension Trial of GW 906 in Participants With Essential Hypertension
Hypertension
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of BR1019A and BR1019B Combination Therapy
Essential Hypertension, Type 2 Diabetes Mellitus
RecruitingObservational study
Global Paradise System US Post Approval Study
Hypertension, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seok Min Kang, M.D., Ph.D principal investigator
Yonsei Cardiovascular Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AD-2021 and AD-2022 in people with Hypertension, Essential and Primary Hypercholesterolemia, run by Addpharma Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low density lipoprotein cholesterol (LDL-C) (time frame: Baseline, Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.