Primary HypercholesterolemiaPhase 3ROSENCT02445352

Efficacy/Safety of DP-R207 Tablet Versus CRESTOR Tablet in Patients With Primary Hypercholesterolemia

A Phase 3 study testing Rosuvastatin 5mg, DP-R207 5/10mg and Rosuvastatin 10mg in people with Primary Hypercholesterolemia, run by Alvogen Korea at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate efficacy and safety of DP-R207 in patients with primary hypercholesterolemia. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Primary Hypercholesterolemia
What is being tested?: Rosuvastatin 5mg, DP-R207 5/10mg and Rosuvastatin 10mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 379 participants
Where: 1 siteSouth Korea
Study dates: Jul 2014to Mar 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged over 19 years
Signed informed consent form
At visit 1 and visit 2, LDL-Cholesterol ≤ 250mg/dL and Triglyderide ≤ 350mg/dL

Who cannot join

Has a history of hypersensitivity to HMG-CoA reductase inhibitor and component of ezeimibe
Liver transaminases > 2 x upper limit of normal

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Severance Hospital
Seodaemun-gu, Seoul, 120-752

Other trials in South Korea

About this study

Official title: A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R207 (Rosuvastatin /Ezetimibe Combination) and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia

The purpose of this study is to evaluate efficacy and safety of DP-R207 in patients with primary hypercholesterolemia.

Conditions: Primary Hypercholesterolemia
Being tested: Rosuvastatin 5mg, DP-R207 5/10mg, Rosuvastatin 10mg, DP-R207 10/10mg, Rosuvastatin 20mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rosuvastatin 5mgDrug
DP-R207 5/10mgDrug
Also called Rosuvastatin 5mg, Ezetimibe 10mg
Rosuvastatin 10mgDrug
DP-R207 10/10mgDrug
Also called Rosuvastatin 10mg, Ezetimibe 10mg
Rosuvastatin 20mgDrug
DP-R207 20/10mgDrug
Also called Rosuvastatin 20mg, Ezetimibe 10mg
Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg)Drug
Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg)Drug
Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)Drug

Study groups in NCT02445352
Study group	Role	What they receive
Rosuvastatin 5mg & Placebo & Placebo	Active comparator	Once a day, administration of rosuvastatin 5mg and two types of placebo for 20 weeks Receives: Drug: Rosuvastatin 5mg; Drug: Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg); Drug: Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)
DP-R207 5/10mg & Placebo & Placebo	Experimental	Once a day, administration of DP-R207 5/10mg and two types of placebo for 20 weeks Receives: Drug: DP-R207 5/10mg; Drug: Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg); Drug: Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)
Rosuvastatin 10mg & Placebo & Placebo	Active comparator	Once a day, administration of rosuvastatin 10mg and two types of placebo for 20 weeks Receives: Drug: Rosuvastatin 10mg; Drug: Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg); Drug: Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)
DP-R207 10/10mg & Placebo & Placebo	Experimental	Once a day, administration of DP-R207 10/10mg and two types of placebo for 20 weeks Receives: Drug: DP-R207 10/10mg; Drug: Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg); Drug: Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)
Rosuvastatin 20mg & Placebo & Placebo	Active comparator	Once a day, administration of rosuvastatin 20mg and two types of placebo for 20 weeks Receives: Drug: Rosuvastatin 20mg; Drug: Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg); Drug: Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg)
DP-R207 20/10mg & Placebo & Placebo	Experimental	Once a day, administration of DP-R207 20/10mg and two types of placebo for 20 weeks Receives: Drug: DP-R207 20/10mg; Drug: Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg); Drug: Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent change from baseline to 8 weeks in LDL-Cholesterol
Measured: baseline and 8 weeks

Secondary outcomes (4)

Percent change from baseline to 4 weeks in LDL-Cholesterol
Measured: baseline and 4 weeks
Percent change from baseline to 4 weeks in lipid related blood test results
Measured: baseline and 4 weeks
Percent change from baseline to 8 weeks in lipid related blood test results
Measured: baseline and 8 weeks
Percentage of patients reaching treatment goals according to NCEP ATP III Guideline
Measured: week 4 and week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Mar 2015

First posted15 May 2015 (estimated)
Study startJul 2014
Primary completionJan 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Primary 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 379 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02445352
Sponsor's protocol ID: DP-CTR207-III-02
Acronym: ROSE
Status last verified: May 2015
First submitted: 13 May 2015
Last updated: 15 May 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Recruiting
Food Supplement for Individuals With Polygenic Hypercholesterolaemia
Polygenic Hypercholesterolaemia
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
RecruitingObservational study
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Primary Hypercholesterolaemia, Mixed Dyslipidemia

All Primary Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R207 (Rosuvastatin /Ezetimibe Combination) and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia
ClinicalTrials.gov ID: NCT02445352
Acronym / sponsor ID: ROSE / DP-CTR207-III-02
Conditions: Primary Hypercholesterolemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 379 participants (actual)
Lead sponsor: Alvogen KoreaIndustry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Jan 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 15 May 2015 (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.

The purpose of this study is to evaluate efficacy and safety of DP-R207 in patients with primary hypercholesterolemia.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Rosuvastatin 5mg & Placebo & Placebo	Active comparator	Drug: Rosuvastatin 5mg, Drug: Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg), Drug: Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)Once a day, administration of rosuvastatin 5mg and two types of placebo for 20 weeks
DP-R207 5/10mg & Placebo & Placebo	Experimental	Drug: DP-R207 5/10mg, Drug: Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg), Drug: Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)Once a day, administration of DP-R207 5/10mg and two types of placebo for 20 weeks
Rosuvastatin 10mg & Placebo & Placebo	Active comparator	Drug: Rosuvastatin 10mg, Drug: Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg), Drug: Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)Once a day, administration of rosuvastatin 10mg and two types of placebo for 20 weeks
DP-R207 10/10mg & Placebo & Placebo	Experimental	Drug: DP-R207 10/10mg, Drug: Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg), Drug: Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)Once a day, administration of DP-R207 10/10mg and two types of placebo for 20 weeks
Rosuvastatin 20mg & Placebo & Placebo	Active comparator	Drug: Rosuvastatin 20mg, Drug: Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg), Drug: Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg)Once a day, administration of rosuvastatin 20mg and two types of placebo for 20 weeks
DP-R207 20/10mg & Placebo & Placebo	Experimental	Drug: DP-R207 20/10mg, Drug: Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg), Drug: Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg)Once a day, administration of DP-R207 20/10mg and two types of placebo for 20 weeks

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Aged over 19 years
Signed informed consent form
At visit 1 and visit 2, LDL-Cholesterol ≤ 250mg/dL and Triglyderide ≤ 350mg/dL

Key exclusion criteria (2 listed)

Has a history of hypersensitivity to HMG-CoA reductase inhibitor and component of ezeimibe
Liver transaminases > 2 x upper limit of normal

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 5mg	Drug	Rosuvastatin 5mg & Placebo & Placebo
DP-R207 5/10mgAlso: Rosuvastatin 5mg, Ezetimibe 10mg	Drug	DP-R207 5/10mg & Placebo & Placebo
Rosuvastatin 10mg	Drug	Rosuvastatin 10mg & Placebo & Placebo
DP-R207 10/10mgAlso: Rosuvastatin 10mg, Ezetimibe 10mg	Drug	DP-R207 10/10mg & Placebo & Placebo
Rosuvastatin 20mg	Drug	Rosuvastatin 20mg & Placebo & Placebo
DP-R207 20/10mgAlso: Rosuvastatin 20mg, Ezetimibe 10mg	Drug	DP-R207 20/10mg & Placebo & Placebo
Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg)	Drug	DP-R207 10/10mg & Placebo & Placebo, DP-R207 20/10mg & Placebo & Placebo, Rosuvastatin 10mg & Placebo & Placebo, Rosuvastatin 20mg & Placebo & Placebo
Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg)	Drug	DP-R207 20/10mg & Placebo & Placebo, DP-R207 5/10mg & Placebo & Placebo, Rosuvastatin 20mg & Placebo & Placebo, Rosuvastatin 5mg & Placebo & Placebo
Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)	Drug	DP-R207 10/10mg & Placebo & Placebo, DP-R207 5/10mg & Placebo & Placebo, Rosuvastatin 10mg & Placebo & Placebo, Rosuvastatin 5mg & Placebo & Placebo

Primary outcome

Percent change from baseline to 8 weeks in LDL-Cholesterol
Time frame: baseline and 8 weeks

4 secondary outcomes

Percent change from baseline to 4 weeks in LDL-Cholesterol
Time frame: baseline and 4 weeks
Percent change from baseline to 4 weeks in lipid related blood test results
Time frame: baseline and 4 weeks
Percent change from baseline to 8 weeks in lipid related blood test results
Time frame: baseline and 8 weeks
Percentage of patients reaching treatment goals according to NCEP ATP III Guideline
Time frame: week 4 and 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 May 2015.

Related trials for Primary Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Recruiting
Food Supplement for Individuals With Polygenic Hypercholesterolaemia
Polygenic Hypercholesterolaemia
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
RecruitingObservational study
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Primary Hypercholesterolaemia, Mixed Dyslipidemia

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.

Yangsoo Jang, Ph.D. study chair

Severance 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 Rosuvastatin 5mg, DP-R207 5/10mg and Rosuvastatin 10mg in people with Primary Hypercholesterolemia, run by Alvogen Korea 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 3 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 May 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 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?

Percent change from baseline to 8 weeks in LDL-Cholesterol (time frame: baseline and 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02445352.

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 May 2015.