HypercholesterolemiaPhase 3NCT02251847
The Efficacy and Safety of a Combination Therapy of Rosuvastatin and Ezetimibe Versus Monotherapy of Rosuvastatin in Hypercholesterolemia Patients
A Phase 3 study testing Rosuvastatin/Ezetimibe in people with Hypercholesterolemia, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.
Trial summary
To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus monotherapy of rosuvastatin in hypercholesterolemia patients Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Rosuvastatin/Ezetimibe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Jul 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypercholesterolemic patient
Who cannot join
- Has history of hypersensitivity to HMG-CoA reductase inhibitor and Ezetimibe
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gil Medical Center
Seoul
Tae Hoon Ahn
About this study
To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus monotherapy of rosuvastatin in hypercholesterolemia patients
Read the detailed description
To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus monotherapy of rosuvastatin in hypercholesterolemia patients
- Conditions
- Hypercholesterolemia
- Being tested
- Rosuvastatin/Ezetimibe
- Keywords
- cholesterol
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin/EzetimibeDrug
Rosuvastatin 5mg
| Study group | Role | What they receive |
|---|---|---|
| R5 | Active comparator | Rosuvastatin 5mg Receives: Drug: Rosuvastatin/Ezetimibe |
| R10 | Active comparator | Rosuvastatin 10mg Receives: Drug: Rosuvastatin/Ezetimibe |
| R20 | Active comparator | Rosuvastatin 20mg Receives: Drug: Rosuvastatin/Ezetimibe |
| R5/E10 | Experimental | Rosuvastatin 5mg/ezetimibe 10mg Receives: Drug: Rosuvastatin/Ezetimibe |
| R10/E10 | Experimental | Rosuvastatin 10mg/ezetimibe 10mg Receives: Drug: Rosuvastatin/Ezetimibe |
| R20/E10 | Experimental | Rosuvastatin 20mg/ezetimibe 10mg Receives: Drug: Rosuvastatin/Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline to 8 week in LDL-Cholesterol
Measured: baseline and 8 week
Secondary outcomes (1)
Percent change from baseline to 4 week in LDL-Cholesterol
Measured: baseline and 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015 (estimated)
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.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tae Hoon Ahn, Principal investigator, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251847
- Sponsor's protocol ID
- ID-ROEZ-301
- Status last verified
- Sep 2014
- First submitted
- 25 Sep 2014
- Last updated
- 29 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of a Combination Therapy of Rosuvastatin and Ezetimibe Versus Monotherapy of Rosuvastatin in Hypercholesterolemia Patients
- ClinicalTrials.gov ID
- NCT02251847
- Acronym / sponsor ID
- ID-ROEZ-301
- Conditions
- Hypercholesterolemia
- Keywords
- cholesterol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (estimated)
- First posted
- 29 Sep 2014 (estimated)
- 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 efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus monotherapy of rosuvastatin in hypercholesterolemia patients
Detailed description
To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus monotherapy of rosuvastatin in hypercholesterolemia patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| R5 | Active comparator | Drug: Rosuvastatin/EzetimibeRosuvastatin 5mg |
| R10 | Active comparator | Drug: Rosuvastatin/EzetimibeRosuvastatin 10mg |
| R20 | Active comparator | Drug: Rosuvastatin/EzetimibeRosuvastatin 20mg |
| R5/E10 | Experimental | Drug: Rosuvastatin/EzetimibeRosuvastatin 5mg/ezetimibe 10mg |
| R10/E10 | Experimental | Drug: Rosuvastatin/EzetimibeRosuvastatin 10mg/ezetimibe 10mg |
| R20/E10 | Experimental | Drug: Rosuvastatin/EzetimibeRosuvastatin 20mg/ezetimibe 10mg |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hypercholesterolemic patient
Key exclusion criteria (1 listed)
- Has history of hypersensitivity to HMG-CoA reductase inhibitor and Ezetimibe
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 |
|---|---|---|
| Rosuvastatin/EzetimibeRosuvastatin 5mg | Drug | R10, R10/E10, R20, R20/E10, R5, R5/E10 |
Primary outcome
Percent change from baseline to 8 week in LDL-Cholesterol
Time frame: baseline and 8 week
1 secondary outcome
Percent change from baseline to 4 week in LDL-Cholesterol
Time frame: baseline and 4 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2014.
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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.
Tae Hoon Ahn principal investigator
Gachon University Gil Medical Center
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 Rosuvastatin/Ezetimibe in people with Hypercholesterolemia, run by IlDong Pharmaceutical 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 29 Sep 2014. 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 Min-Hee Kwon (02-526-3379, minhee@ildong.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline to 8 week in LDL-Cholesterol (time frame: baseline and 8 week). 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 29 Sep 2014.