Primary HypercholesterolemiaPhase 3NCT05206578
Study to Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia
A Phase 3 study testing AGT2, AGZ, AGT2 and AGT4, AGZ in people with Primary Hypercholesterolemia, run by Ahn-Gook Pharmaceuticals Co.,Ltd at 1 site in South Korea.
Trial summary
To Evaluate the Efficacy and Safety of Combination Therapy of AGT and AGZ Versus Monotherapy of AGT in Patients With Primary Hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Primary Hypercholesterolemia
- What is being tested?
- AGT2, AGZ, AGT2 and AGT4, AGZ
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Dec 2020to 8 Sep 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary hypercholesterolemia
Who cannot join
- The subject not meet the specified LDL-C level
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Evaluate the Efficacy and Safety of Combination Therapy of AGT and AGZ Versus Monotherapy of AGT in Patients With Primary Hypercholesterolemia
To Evaluate the Efficacy and Safety of Combination Therapy of AGT and AGZ Versus Monotherapy of AGT in Patients With Primary Hypercholesterolemia.
Read the detailed description
A Multi-center, Randomized, Double-blinded, Active-controlled, Factorial Design Phase 3 Clinical Trial
- Conditions
- Primary Hypercholesterolemia
- Being tested
- AGT2, AGZ, AGT2, AGT4, AGZ, AGT4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGT2, AGZDrug
Tablet, q.d.
AGT2Drug
Tablet, q.d.
AGT4, AGZDrug
Tablet, q.d.
AGT4Drug
Tablet, q.d.
| Study group | Role | What they receive |
|---|---|---|
| AGT2, AGZ | Experimental | Not described Receives: Drug: AGT2, AGZ |
| AGT2 | Active comparator | Not described Receives: Drug: AGT2 |
| AGT4, AGZ | Experimental | Not described Receives: Drug: AGT4, AGZ |
| AGT4 | Active comparator | Not described Receives: Drug: AGT4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
% change in LDL-C level from baseline at Week 8
change in LDL-C level
Measured: Week 8
Secondary outcomes (1)
Change in LDL-C level from baseline at Week 4
change in LDL-C level
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start8 Dec 2020
- Primary completion7 Jul 2022 (estimated)
- Study completion8 Sep 2022 (estimated)
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.
- 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206578
- Sponsor's protocol ID
- AG1901 P3
- Status last verified
- Jan 2022
- First submitted
- 12 Jan 2022
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Efficacy and Safety of Combination Therapy of AGT and AGZ Versus Monotherapy of AGT in Patients With Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT05206578
- Acronym / sponsor ID
- AG1901 P3
- Conditions
- Primary Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 7 Jul 2022 (estimated)
- Study completion
- 8 Sep 2022 (estimated)
- First posted
- 25 Jan 2022 (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.
To Evaluate the Efficacy and Safety of Combination Therapy of AGT and AGZ Versus Monotherapy of AGT in Patients With Primary Hypercholesterolemia.
Detailed description
A Multi-center, Randomized, Double-blinded, Active-controlled, Factorial Design Phase 3 Clinical Trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AGT2, AGZ | Experimental | Drug: AGT2, AGZ |
| AGT2 | Active comparator | Drug: AGT2 |
| AGT4, AGZ | Experimental | Drug: AGT4, AGZ |
| AGT4 | Active comparator | Drug: AGT4 |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with primary hypercholesterolemia
Key exclusion criteria (1 listed)
- The subject not meet the specified LDL-C level
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 |
|---|---|---|
| AGT2, AGZTablet, q.d. | Drug | AGT2, AGZ |
| AGT2Tablet, q.d. | Drug | AGT2 |
| AGT4, AGZTablet, q.d. | Drug | AGT4, AGZ |
| AGT4Tablet, q.d. | Drug | AGT4 |
Primary outcome
% change in LDL-C level from baseline at Week 8
Time frame: Week 8
change in LDL-C level
1 secondary outcome
Change in LDL-C level from baseline at Week 4
Time frame: Week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
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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.
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 AGT2, AGZ, AGT2 and AGT4, AGZ in people with Primary Hypercholesterolemia, run by Ahn-Gook Pharmaceuticals Co.,Ltd 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yumi Hong (02-3289-4238, ymhelena@ahn-gook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% change in LDL-C level from baseline at Week 8 (time frame: 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 25 Jan 2022.