Primary HypercholesterolemiaPhase 3NCT05131997
A Study to Evaluate the Efficacy and Safety of AD-221 and AD-221A
A Phase 3 study testing AD-221, AD-221A and AD-221B in people with 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 AD-221 and AD-221A Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Primary Hypercholesterolemia
- What is being tested?
- AD-221, AD-221A and AD-221B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Nov 2021to 8 Jun 2022
- 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 primary hypercholesterolemia
Who cannot join
- Patient with secondary dyslipidemia
- 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 Administrated AD-221 and AD-221A in Patients With Primary Hypercholesterolemia
The purpose of this study is to evaluate the efficacy and safety of AD-221 and AD-221A
Read the detailed description
The purpose of this study is to evaluate the efficacy and safety of AD-221 and AD-221A in patients with primary hypercholesterolemia
- Conditions
- Primary Hypercholesterolemia
- Being tested
- AD-221, AD-221A, AD-221B, AD-221C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-221Drug
PO, Once daily(QD), 8 weeks
AD-221ADrug
PO, Once daily(QD), 8 weeks
AD-221BDrug
Also called Ezetimibe
PO, Once daily(QD), 8 weeks
AD-221CDrug
Also called Atorvastatin
PO, Once daily(QD), 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| AD-221 | Experimental | AD-221, Placebo of AD-221A, AD-221B and AD-221C Receives: Drug: AD-221 |
| AD-221A | Experimental | AD-221A, Placebo of AD-221, AD-221B and AD-221C Receives: Drug: AD-221A |
| AD-221B | Active comparator | AD-221B, Placebo of AD-221, AD-221A and AD-221C Receives: Drug: AD-221B |
| AD-221C | Active comparator | AD-221C, Placebo of AD-221, AD-221A and AD-221B Receives: Drug: AD-221C |
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
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 posted23 Nov 2021
- Study start16 Nov 2021
- Primary completion8 Jun 2022
- Study completion8 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Addpharma Inc.The sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addpharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sang Hak Lee, M.D., Ph.D, Principal investigator, Yonsei University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131997
- Sponsor's protocol ID
- AD-221P3
- Status last verified
- Jul 2022
- First submitted
- 10 Nov 2021
- Last updated
- 20 Jul 2022
- 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 20 Jul 2022. 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 Administrated AD-221 and AD-221A in Patients With Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT05131997
- Acronym / sponsor ID
- AD-221P3
- Conditions
- Primary Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 23 Nov 2021 (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 AD-221 and AD-221A
Detailed description
The purpose of this study is to evaluate the efficacy and safety of AD-221 and AD-221A in patients with primary hypercholesterolemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AD-221 | Experimental | Drug: AD-221AD-221, Placebo of AD-221A, AD-221B and AD-221C |
| AD-221A | Experimental | Drug: AD-221AAD-221A, Placebo of AD-221, AD-221B and AD-221C |
| AD-221B | Active comparator | Drug: AD-221BAD-221B, Placebo of AD-221, AD-221A and AD-221C |
| AD-221C | Active comparator | Drug: AD-221CAD-221C, Placebo of AD-221, AD-221A and AD-221B |
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 primary hypercholesterolemia
Key exclusion criteria (2 listed)
- Patient with secondary dyslipidemia
- 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-221PO, Once daily(QD), 8 weeks | Drug | AD-221 |
| AD-221APO, Once daily(QD), 8 weeks | Drug | AD-221A |
| AD-221BAlso: EzetimibePO, Once daily(QD), 8 weeks | Drug | AD-221B |
| AD-221CAlso: AtorvastatinPO, Once daily(QD), 8 weeks | Drug | AD-221C |
Primary outcome
Low density lipoprotein cholesterol (LDL-C)
Time frame: Baseline, Week 8
LDL-C change at Week 8
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 20 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Sang Hak Lee, M.D., Ph.D principal investigator
Yonsei University 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-221, AD-221A and AD-221B in people with 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 20 Jul 2022. 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). 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 20 Jul 2022.