Mixed DyslipidemiasPhase 3NCT02262143
Phase III Study of Rosuvastatin and Fenofibrate Versus Rosuvastatin in Mixed Dyslipidemia
A Phase 3 study testing Rosuvastatin and Fenofibrate in people with Mixed Dyslipidemias, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.
Trial summary
Efficacy and safety of combination therapy of rosuvastatin and fenofibrate versus rosuvastatin monotherapy in mixed dyslipidemia patients: A randomized, multi-center, double-blind, phase 3 study Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Mixed Dyslipidemias
- What is being tested?
- Rosuvastatin and Fenofibrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2014to Jun 2017
- 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
- 19 ~ 80 years old
- High risk patient to Coronary Heart Disease
- At Visit 1(Screening)
- Treated with Rosuvastatin 10mg monotherapy 4weeks prior to this study
- 110 mg/dl ≥ LDL-C, 200 mg/dl ≤ TG ≤ 500 mg/dl
- At Visit 2 (Baseline), 110 mg/dl ≥ LDL-C, 200 mg/dl ≤ TG ≤ 500 mg/dl
Who cannot join
- AST or ALT > 2X ULN
- Patients with uncontrolled hyperthyroidism (TSH>1.5X ULN)
- Patients with uncontrolled diabetes (HbA1c ≥ 9%)
- Patients with uncontrolled hypertension(SBP>160mmHg or DBP>95mmHg)
- Patients with congestive heart failure(NYHA class III~IV) or uncontrolled arrhythmia within 6 months
- Patients treated with any investigational drugs within 3 months at the time consents are obtained
- Not eligible to participate for the study at the discretion of investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Combination Therapy of Rosuvastatin and Fenofibrate Versus Rosuvastatin Monotherapy in Mixed Dyslipidemia Patients
Efficacy and safety of combination therapy of rosuvastatin and fenofibrate versus rosuvastatin monotherapy in mixed dyslipidemia patients: A randomized, multi-center, double-blind, phase 3 study
- Conditions
- Mixed Dyslipidemias
- Being tested
- Rosuvastatin, Fenofibrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor Tab.
Rosuvastatin 10 mg, qd, po
FenofibrateDrug
Also called Lipidil supra Tab.
Fenofibrate 160mg, qd, po
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Rosuvastatin 10 mg, Fenofibrate 160 mg Receives: Drug: Rosuvastatin; Drug: Fenofibrate |
| Comparator | Active comparator | Rosuvastatin 10 mg Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean percent change of Non-HDL Cholesterol
Measured: from baseline at week 8
Secondary outcomes (4)
The mean change, percent change of Non-LDL-C
Measured: from baseline at week 4
The mean change of Non-LDL-C
Measured: from baseline at week 8
The mean percent change of LDL-C, HDL-C, VLDL-C, TG, TC, Apo-AI, Apo-B
Measured: from baseline at week 4, 8
The achievement rate of Non-HDL-C<130mg/dl
Measured: from baseline at week 4, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionOct 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed DyslipidemiasStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeongtaeck Woo, M.D., Ph.D, Principal investigator, Kyunghee University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262143
- Sponsor's protocol ID
- ID-ROFE-301
- Status last verified
- Aug 2018
- First submitted
- 7 Oct 2014
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Combination Therapy of Rosuvastatin and Fenofibrate Versus Rosuvastatin Monotherapy in Mixed Dyslipidemia Patients
- ClinicalTrials.gov ID
- NCT02262143
- Acronym / sponsor ID
- ID-ROFE-301
- Conditions
- Mixed Dyslipidemias
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 10 Oct 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.
Efficacy and safety of combination therapy of rosuvastatin and fenofibrate versus rosuvastatin monotherapy in mixed dyslipidemia patients: A randomized, multi-center, double-blind, phase 3 study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Rosuvastatin, Drug: FenofibrateRosuvastatin 10 mg, Fenofibrate 160 mg |
| Comparator | Active comparator | Drug: RosuvastatinRosuvastatin 10 mg |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 19 ~ 80 years old
- High risk patient to Coronary Heart Disease
- At Visit 1(Screening)
- At Visit 2 (Baseline), 110 mg/dl ≥ LDL-C, 200 mg/dl ≤ TG ≤ 500 mg/dl
Key exclusion criteria (7 listed)
- AST or ALT > 2X ULN
- Patients with uncontrolled hyperthyroidism (TSH>1.5X ULN)
- Patients with uncontrolled diabetes (HbA1c ≥ 9%)
- Patients with uncontrolled hypertension(SBP>160mmHg or DBP>95mmHg)
- Patients with congestive heart failure(NYHA class III~IV) or uncontrolled arrhythmia within 6 months
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 |
|---|---|---|
| RosuvastatinAlso: Crestor Tab.Rosuvastatin 10 mg, qd, po | Drug | Comparator, Experimental |
| FenofibrateAlso: Lipidil supra Tab.Fenofibrate 160mg, qd, po | Drug | Experimental |
Primary outcome
The mean percent change of Non-HDL Cholesterol
Time frame: from baseline at week 8
4 secondary outcomes
The mean change, percent change of Non-LDL-C
Time frame: from baseline at week 4
The mean change of Non-LDL-C
Time frame: from baseline at week 8
The mean percent change of LDL-C, HDL-C, VLDL-C, TG, TC, Apo-AI, Apo-B
Time frame: from baseline at week 4, 8
The achievement rate of Non-HDL-C<130mg/dl
Time frame: from baseline at week 4, 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 24 Aug 2018.
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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.
Jeongtaeck Woo, M.D., Ph.D principal investigator
Kyunghee University 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 and Fenofibrate in people with Mixed Dyslipidemias, 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 6 inclusion and 7 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 24 Aug 2018. 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?
The mean percent change of Non-HDL Cholesterol (time frame: from baseline at 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 24 Aug 2018.