HypercholesterolemiaPhase 3NCT02390375
Phase 3 Study to Evaluate the Efficacy and Safety of the DW0929 in Patients With Primary Hypercholesterolemia
A Phase 3 study testing DW-0929 and Rosuvastatin in people with Hypercholesterolemia, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of the DW0929 in patients with primary hypercholesterolemia Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- DW-0929 and Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2014to May 2016
- 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
- Adult over 19years
- Patients with primary hypercholesterolemia whose LDL-C level is below 250mg/dL and TG level is below 350mg/dL
- Patients whose LDL-C level is under 'Anti- dyslipidemia drug administration considered standard' of NCEP ATP III(2004)
- Those who voluntarily written consent to participate in this clinical trial
Who cannot join
- Uncontrolled hypertension
- Severe renal impairment(CrCl<30mL/min)
- Those who have active liver disease and whose ALT, AST levels greater than twice the upper limit of normal
- Serum creatinine > 2.0mg/dL
- Those who have been geunyukbyeong or rhabdomyolysis caused by using statin or have hypersensitivity to ezetimibe
- Combined cyclosporine -treated patients
Show all 20Show fewer
- HbA1c ≥ 9%
- TSH ≥ 1.5 X ULN
- HIV-positive person
- Congestive heart failure patients classified as NYHA Class III or IV
- Patients with uncontrolled arrhythmias
- Patients who have malignant tumors needed chemotherapy, radiation therapy, etc.
- Blood clotting disorders
- Patients who had a myocardial infarction within 6 months or cardiovascular bypass surgery, patients who have underwent angioplasty
- Patients who had a history of anxiety or severe typical peripheral arterial disease within three months
- Women of childbearing age who don't agree with contraception during this clinical trials
- Pregnant women or nursing mothers
- Those who take the drug in combination taboo
- Who have been treated for another investigational drug within 30 days
- Unsuitable characters in a clinical trial to test self- determination
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the efficacy and safety of the DW0929 in patients with primary hypercholesterolemia
- Conditions
- Hypercholesterolemia
- Being tested
- DW-0929, Rosuvastatin
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DW-0929Drug
5/10mg
DW-0929Drug
10/10mg
DW-0929Drug
20/10mg
RosuvastatinDrug
5mg F/U study: DW-0929 5/10mg
RosuvastatinDrug
10mg F/U study: DW-0929 10/10mg
RosuvastatinDrug
20mg F/U study: DW-0929 20/10mg
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | DW-0929 Receives: Drug: DW-0929 |
| B | Active comparator | Rosuvastatin Receives: Drug: DW-0929; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C level
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startNov 2014
- Primary completionApr 2016
- Study completionMay 2016
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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390375
- Sponsor's protocol ID
- DW-0929_P301
- Status last verified
- Oct 2016
- First submitted
- 11 Mar 2015
- Last updated
- 10 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study to Evaluate the Efficacy and Safety of the DW0929 in Patients With Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT02390375
- Acronym / sponsor ID
- DW-0929_P301
- Conditions
- Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 Mar 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 the efficacy and safety of the DW0929 in patients with primary hypercholesterolemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: DW-0929DW-0929 |
| B | Active comparator | Drug: DW-0929, Drug: RosuvastatinRosuvastatin |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult over 19years
- Patients with primary hypercholesterolemia whose LDL-C level is below 250mg/dL and TG level is below 350mg/dL
- Patients whose LDL-C level is under 'Anti- dyslipidemia drug administration considered standard' of NCEP ATP III(2004)
- Those who voluntarily written consent to participate in this clinical trial
Key exclusion criteria (20 listed)
- Uncontrolled hypertension
- Severe renal impairment(CrCl<30mL/min)
- Those who have active liver disease and whose ALT, AST levels greater than twice the upper limit of normal
- Serum creatinine > 2.0mg/dL
- Those who have been geunyukbyeong or rhabdomyolysis caused by using statin or have hypersensitivity to 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 |
|---|---|---|
| DW-09295/10mg | Drug | A, B |
| DW-092910/10mg | Drug | A, B |
| DW-092920/10mg | Drug | A, B |
| Rosuvastatin5mg F/U study: DW-0929 5/10mg | Drug | B |
| Rosuvastatin10mg F/U study: DW-0929 10/10mg | Drug | B |
| Rosuvastatin20mg F/U study: DW-0929 20/10mg | Drug | B |
Primary outcome
LDL-C level
Time frame: 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 10 Oct 2016.
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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 3 study testing DW-0929 and Rosuvastatin in people with Hypercholesterolemia, run by Daewon 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 4 inclusion and 20 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 10 Oct 2016. 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?
LDL-C level (time frame: 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 10 Oct 2016.