HypercholesterolemiaPhase 3NCT03872232
Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan
A Phase 3 study testing Ezetimibe/Rosuvastatin and Telmisartan 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 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 and Telmisartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Feb 2019to 12 Aug 2020
- 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 Phase3 Trial to Evaluate the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan 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 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 in patients with primary hypercholesterolemia and essential hypertension.
In "Rosuvastatin/Ezetimibe+Telmisartan" treatment group, 60 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan" for 8 weeks.
In "Rosuvastatin/Ezetimibe" treatment group, 60 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe" for 8 weeks.
In "Telmisartan" treatment group, 60 subjects will be assigned and the subjects administer "Telmisartan" for 8 weeks.
- Conditions
- Hypercholesterolemia, Hypertension
- Being tested
- Ezetimibe/Rosuvastatin, Telmisartan
- 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
| Study group | Role | What they receive |
|---|---|---|
| Ezetimibe/Rosuvastatin and Telmisartan | Experimental | 60 subjects will be assigned and the subjects will be administered "Ezetimibe/Rosuvastatin and Telmisartan" for 8 weeks. Receives: Drug: Ezetimibe/Rosuvastatin; Drug: Telmisartan |
| Ezetimibe/Rosuvastatin | Active comparator | 60 subjects will be assigned and the subjects will be administered "Ezetimibe/Rosuvastatin" for 8 weeks. Receives: Drug: Ezetimibe/Rosuvastatin |
| Telmisartan | Active comparator | 60 subjects will be assigned and the subjects will be administered "Telmisartan" for 8 weeks. Receives: Drug: Telmisartan |
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 to Baseline
Measured: Baseline, Week 8
Mean sitting systolic blood pressure (MSSBP)
MSSBP change at Week 8 compared to Baseline
Measured: Baseline, Week 8
Secondary outcomes (8)
Mean sitting systolic blood pressure (MSSBP)
MSSBP change at Week 4 compared to Baseline
Measured: Baseline, Week 4
Low density lipoprotein cholesterol (LDL-C)
LDL-C change at Week 4 compared to Baseline
Measured: Baseline, Week 4
Mean sitting diastolic blood pressure (MSDBP)
MSDBP change at Week 4, 8 compared to Baseline
Measured: Baseline, Week 4, Week 8
Total Cholesterol (TC)
TC change at Week 4, 8 compared to Baseline
Measured: Baseline, Week 4, Week 8
High density lipoprotein cholesterol (HDL-C)
HDL-C change at Week 4, 8 compared to Baseline
Measured: Baseline, Week 4, Week 8
Triglyceride (TG)
TG change at Week 4, 8 compared to Baseline
Measured: Baseline, Week 4, Week 8
Low density lipoprotein cholesterol/High density lipoprotein cholesterol (LDL-C/HDL-C)
LDL-C/HDL-C change at Week 4, 8 compared to Baseline
Measured: Baseline, Week 4, Week 8
Total Cholesterol/High density lipoprotein cholesterol (TC/HDL-C)
TC/HDL-C change at Week 4,8 compared to Baseline
Measured: Baseline, Week 4, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start26 Feb 2019
- Primary completion12 Aug 2020
- Study completion12 Aug 2020
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 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
- NCT03872232
- Sponsor's protocol ID
- ROZETEL_RCT
- Status last verified
- Jan 2021
- First submitted
- 11 Mar 2019
- Last updated
- 15 Jan 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 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active-controlled, Multicenter Phase3 Trial to Evaluate the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan in Patients With Primary Hypercholesterolemia and Essential Hypertension
- ClinicalTrials.gov ID
- NCT03872232
- Acronym / sponsor ID
- ROZETEL_RCT
- Conditions
- Hypercholesterolemia, Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 12 Aug 2020 (actual)
- Study completion
- 12 Aug 2020 (actual)
- First posted
- 13 Mar 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 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 in patients with primary hypercholesterolemia and essential hypertension.
In "Rosuvastatin/Ezetimibe+Telmisartan" treatment group, 60 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan" for 8 weeks.
In "Rosuvastatin/Ezetimibe" treatment group, 60 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe" for 8 weeks.
In "Telmisartan" treatment group, 60 subjects will be assigned and the subjects administer "Telmisartan" for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ezetimibe/Rosuvastatin and Telmisartan | Experimental | Drug: Ezetimibe/Rosuvastatin, Drug: Telmisartan60 subjects will be assigned and the subjects will be administered "Ezetimibe/Rosuvastatin and Telmisartan" for 8 weeks. |
| Ezetimibe/Rosuvastatin | Active comparator | Drug: Ezetimibe/Rosuvastatin60 subjects will be assigned and the subjects will be administered "Ezetimibe/Rosuvastatin" for 8 weeks. |
| Telmisartan | Active comparator | Drug: Telmisartan60 subjects will be assigned and the subjects will be administered "Telmisartan" 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 | Ezetimibe/Rosuvastatin, Ezetimibe/Rosuvastatin and Telmisartan |
| TelmisartanAlso: Micardis Tab.PO, Once daily(QD), 8weeks | Drug | Ezetimibe/Rosuvastatin and Telmisartan, Telmisartan |
Primary outcome
Low density lipoprotein cholesterol (LDL-C)
Time frame: Baseline, Week 8
LDL-C change at Week 8 compared to Baseline
Mean sitting systolic blood pressure (MSSBP)
Time frame: Baseline, Week 8
MSSBP change at Week 8 compared to Baseline
8 secondary outcomes
Mean sitting systolic blood pressure (MSSBP)
Time frame: Baseline, Week 4
Low density lipoprotein cholesterol (LDL-C)
Time frame: Baseline, Week 4
Mean sitting diastolic blood pressure (MSDBP)
Time frame: Baseline, Week 4, Week 8
Total Cholesterol (TC)
Time frame: Baseline, Week 4, Week 8
High density lipoprotein cholesterol (HDL-C)
Time frame: Baseline, Week 4, Week 8
Triglyceride (TG)
Time frame: Baseline, Week 4, Week 8
Low density lipoprotein cholesterol/High density lipoprotein cholesterol (LDL-C/HDL-C)
Time frame: Baseline, Week 4, Week 8
Total Cholesterol/High density lipoprotein cholesterol (TC/HDL-C)
Time frame: Baseline, Week 4, 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 15 Jan 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 and Telmisartan 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 15 Jan 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 15 Jan 2021.