HyperlipidemiaPhase 4NCT02280590
Comparison of the Efficacy and Safety of Cresnon® and Crestor® in Patients With Hyperlipidemia
A Phase 4 study testing Rosuvastatin(Cresnon®) and Rosuvastatin(Crestor®) in people with Hyperlipidemia, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
Comparison of the efficacy and safety of Cresnon® and Crestor® in patients with hyperlipidemia 8-week, active-controlled, open-label, randomized, parallelgroup, fixed-dose, noninferiority, multicenter, phase 4 design Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Rosuvastatin(Cresnon®) and Rosuvastatin(Crestor®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2014to Jun 2015
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 20
- Persons who have not reached LDL-C targeted level in accordance with the treatment guidelines for dyslipidemia released by Korean Society of Lipidology and Atherosclerosis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Comparison of the efficacy and safety of Cresnon® and Crestor® in patients with hyperlipidemia
- 8-week, active-controlled, open-label, randomized, parallelgroup, fixed-dose, noninferiority, multicenter, phase 4 design
- Conditions
- Hyperlipidemia
- Being tested
- Rosuvastatin(Cresnon®), Rosuvastatin(Crestor®)
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin(Cresnon®)Drug
10mg
Rosuvastatin(Crestor®)Drug
10mg
| Study group | Role | What they receive |
|---|---|---|
| Cresnon® | Experimental | Rosuvastatin 10mg, tablet, q.d. Receives: Drug: Rosuvastatin(Cresnon®) |
| Crestor® | Active comparator | Rosuvastatin 10mg, tablet, q.d. Receives: Drug: Rosuvastatin(Crestor®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent change in LDL-C
Measured: After taken medication for 8 weeks
Secondary outcomes (2)
The percent change in total cholesterol, Triglyceride, HDL-C, non-HDL-C, and non-HDL-C/HDL-C
Measured: After taken medication for 8 weeks
The proportion of subjects reaching LDL-C targeted level in accordance with the treatment guidelines for dyslipidemia released by Korean Society of Lipidology and Atherosclerosis
Measured: After taken medication for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280590
- Sponsor's protocol ID
- CNT_HLP_IV
- Status last verified
- Jul 2015
- First submitted
- 29 Oct 2014
- Last updated
- 7 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety of Cresnon® and Crestor® in Patients With Hyperlipidemia
- ClinicalTrials.gov ID
- NCT02280590
- Acronym / sponsor ID
- CNT_HLP_IV
- Conditions
- Hyperlipidemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- First posted
- 31 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.
Comparison of the efficacy and safety of Cresnon® and Crestor® in patients with hyperlipidemia
- 8-week, active-controlled, open-label, randomized, parallelgroup, fixed-dose, noninferiority, multicenter, phase 4 design
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cresnon® | Experimental | Drug: Rosuvastatin(Cresnon®)Rosuvastatin 10mg, tablet, q.d. |
| Crestor® | Active comparator | Drug: Rosuvastatin(Crestor®)Rosuvastatin 10mg, tablet, q.d. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 20
- Persons who have not reached LDL-C targeted level in accordance with the treatment guidelines for dyslipidemia released by Korean Society of Lipidology and Atherosclerosis
Key exclusion criteria (0 listed)
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(Cresnon®)10mg | Drug | Cresnon® |
| Rosuvastatin(Crestor®)10mg | Drug | Crestor® |
Primary outcome
The percent change in LDL-C
Time frame: After taken medication for 8 weeks
2 secondary outcomes
The percent change in total cholesterol, Triglyceride, HDL-C, non-HDL-C, and non-HDL-C/HDL-C
Time frame: After taken medication for 8 weeks
The proportion of subjects reaching LDL-C targeted level in accordance with the treatment guidelines for dyslipidemia released by Korean Society of Lipidology and Atherosclerosis
Time frame: After taken medication for 8 weeks
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 7 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin(Cresnon®) and Rosuvastatin(Crestor®) in people with Hyperlipidemia, run by Dong-A ST 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 2 inclusion and 0 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 7 Jul 2015. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 percent change in LDL-C (time frame: After taken medication for 8 weeks). 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 7 Jul 2015.