HypercholesterolemiaPhase 3NCT04158076
Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine
A Phase 3 study testing Ezetimibe/Rosuvastatin, Telmisartan and Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET in people with Hypercholesterolemia and Hypertension, 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 Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine in patients with primary hypercholesterolemia and essential hypertension. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypercholesterolemia, Hypertension
- What is being tested?
- Ezetimibe/Rosuvastatin, Telmisartan and Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jan 2020to 14 Jan 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 III Trial to Evaluate the Efficacy and Safety of Co-administrated AD-2071 and AD-2073 in Patients With Primary Hypercholesterolemia and Essential Hypertension
The purpose of this study is to evaluate the efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine in patients with primary hypercholesterolemia and essential hypertension.
Read the detailed description
This trial is a phase 3 study to evaluate efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine in patients with primary hypercholesterolemia and essential hypertension.
In "Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine" treatment group, 48 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine" for 8 weeks.
In "Rosuvastatin/Ezetimibe +Telmisartan " treatment group, 48 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan" for 8 weeks.
In "Telmisartan/Amlodipine" treatment group, 48 subjects will be assigned and the subjects administer "Telmisartan/Amlodipine" for 8 weeks.
- Conditions
- Hypercholesterolemia, Hypertension
- Being tested
- Ezetimibe/Rosuvastatin, Telmisartan, Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET
- Medical subject headings
- Hypercholesterolemia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ezetimibe/RosuvastatinDrug
Also called Rosuvamibe Tab.
PO, Once daily(QD), 8weeks
TelmisartanDrug
Also called Micardis Tab.
PO, Once daily(QD), 8weeks
Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLETDrug
Also called Twynsta
PO, Once daily(QD), 8weeks
| Study group | Role | What they receive |
|---|---|---|
| Co-administered of AD-2071 and AD-2073 | Experimental | 48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2073(Telmisartan/Amlodipine)" for 8 weeks. Receives: Drug: Ezetimibe/Rosuvastatin; Drug: Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET |
| Co-administered of AD-2071 and AD-2072 | Active comparator | 48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2072(Telmisartan)" for 8 weeks. Receives: Drug: Ezetimibe/Rosuvastatin; Drug: Telmisartan |
| AD-2073 | Active comparator | 48 subjects will be assigned and the subjects will be administered "AD-2073(Telmisartan/Amlodipine)" for 8 weeks. Receives: Drug: Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET |
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-2071 + AD-2073 with AD-2073
Measured: Baseline, Week 8
Mean sitting systolic blood pressure (MSSBP)
MSSBP change at Week 8 compared AD-2071 + AD-2072 with AD-2071 + AD-2073
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 posted8 Nov 2019
- Study start23 Jan 2020
- Primary completion14 Jan 2021
- Study completion14 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addpharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyo Soo Kim, M.D., Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158076
- Sponsor's protocol ID
- ROZETELA RCT
- Status last verified
- May 2021
- First submitted
- 7 Nov 2019
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- 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 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active-controlled, Multicenter Phase III Trial to Evaluate the Efficacy and Safety of Co-administrated AD-2071 and AD-2073 in Patients With Primary Hypercholesterolemia and Essential Hypertension
- ClinicalTrials.gov ID
- NCT04158076
- Acronym / sponsor ID
- ROZETELA RCT
- Conditions
- Hypercholesterolemia, Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 14 Jan 2021 (actual)
- First posted
- 8 Nov 2019 (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 Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine in patients with primary hypercholesterolemia and essential hypertension.
Detailed description
This trial is a phase 3 study to evaluate efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine in patients with primary hypercholesterolemia and essential hypertension.
In "Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine" treatment group, 48 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine" for 8 weeks.
In "Rosuvastatin/Ezetimibe +Telmisartan " treatment group, 48 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan" for 8 weeks.
In "Telmisartan/Amlodipine" treatment group, 48 subjects will be assigned and the subjects administer "Telmisartan/Amlodipine" for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Co-administered of AD-2071 and AD-2073 | Experimental | Drug: Ezetimibe/Rosuvastatin, Drug: Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2073(Telmisartan/Amlodipine)" for 8 weeks. |
| Co-administered of AD-2071 and AD-2072 | Active comparator | Drug: Ezetimibe/Rosuvastatin, Drug: Telmisartan48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2072(Telmisartan)" for 8 weeks. |
| AD-2073 | Active comparator | Drug: Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET48 subjects will be assigned and the subjects will be administered "AD-2073(Telmisartan/Amlodipine)" for 8 weeks. |
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 |
|---|---|---|
| Ezetimibe/RosuvastatinAlso: Rosuvamibe Tab.PO, Once daily(QD), 8weeks | Drug | Co-administered of AD-2071 and AD-2072, Co-administered of AD-2071 and AD-2073 |
| TelmisartanAlso: Micardis Tab.PO, Once daily(QD), 8weeks | Drug | Co-administered of AD-2071 and AD-2072 |
| Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLETAlso: TwynstaPO, Once daily(QD), 8weeks | Drug | AD-2073, Co-administered of AD-2071 and AD-2073 |
Primary outcome
Low density lipoprotein cholesterol (LDL-C)
Time frame: Baseline, Week 8
LDL-C change at Week 8 compared AD-2071 + AD-2073 with AD-2073
Mean sitting systolic blood pressure (MSSBP)
Time frame: Baseline, Week 8
MSSBP change at Week 8 compared AD-2071 + AD-2072 with AD-2071 + AD-2073
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 12 May 2021.
- 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.
Hyo Soo Kim, M.D., Ph.D principal investigator
Seoul National 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 Ezetimibe/Rosuvastatin, Telmisartan and Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET in people with Hypercholesterolemia and Hypertension, 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 12 May 2021. 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 12 May 2021.