HypercholesterolemiaPhase 2NCT02368613
A Clinical Trial for Evaluation of Adequate Dose and Safety of DW-3102 in Hypercholesterolemia Patients
A Phase 2 study testing DW-3102 in people with Hypercholesterolemia, run by Daewon Pharmaceutical Co., Ltd..
Trial summary
The purpose of this study is to evaluate adequate-dose of DW-3102 in the treatment of hypercholesterolemia patients by conducting phase 2a. 4 groups involving placebo group, each groups are composed by 16, will be participated in this trial. 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-3102
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Oct 2017
- Phase
- Phase 2
- 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
- More than 19 years old
- Those who meet the fasting serum lipid levels along table
- Those who are under 350 mg/dL of TG level when fasting
Who cannot join
- The patient of acute arterial disease
- The patient of severe heart failure(NYHA class III or IV)
- Within the last 6 months clinically meaningful treatment that requires that arrhythmias or cardiac conduction disorders
- Uncontrolled hypertension ( systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 110mmHg or more later)
- Endocrine or metabolic disease patients known to affect serum lipids or lipoproteins
- Fibromyalgia, myopathy, rhabdomyolysis, or sudden muscle pain or have in the past, such as statin (HMG CoA reductase inhibitors) in patients with muscle -related adverse drug experience of the system
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- Drug malabsorption by gastrointestinal surgery experience (but simple appendectomy and hernia surgery is excluded) or gastrointestinal disorders ( Crohn's disease , ulcers , acute or chronic pancreatitis , etc. )
- Patients with history of malignancies including leukemia and lymphoma within the past five years
- If severe renal impairment or in patients with impaired liver and hematological findings following the same
- Patients who have participated in another clinical trial within the previous 30 days or Prior to the administration of at least five times the half-life of the active ingredient is not elapsed patient IND
- Those having a known hypersensitivity to hyperlipidemia treatment
- Patients with hypersensitivity or allergy to cruciferous plants
- Patients with a history of drug or alcohol abuse within the last 12 months
- Female patients of childbearing age
- In the case of male test subjects , if the spouse does not agree with the use of childbearing age when women work , recognized contraception exclusion criteria presented in Section 15
- Patient who are inappropriate by investigator's decision
About this study
The purpose of this study is to evaluate adequate-dose of DW-3102 in the treatment of hypercholesterolemia patients by conducting phase 2a. 4 groups involving placebo group, each groups are composed by 16, will be participated in this trial.
- Conditions
- Hypercholesterolemia
- Being tested
- DW-3102
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DW-3102Drug
| Study group | Role | What they receive |
|---|---|---|
| placebo group | Placebo comparator | Placebo Receives: Drug: DW-3102 |
| test1 group | Active comparator | DW-3102 125mg Receives: Drug: DW-3102 |
| test2 group | Active comparator | DW-3102 250mg Receives: Drug: DW-3102 |
| test3 group | Active comparator | DW-3102 500mg Receives: Drug: DW-3102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of LDL-C%
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Primary completionOct 2017 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (estimated)
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
- NCT02368613
- Sponsor's protocol ID
- DW-3102_201
- Status last verified
- Oct 2016
- First submitted
- 15 Feb 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
- A Clinical Trial for Evaluation of Adequate Dose and Safety of DW-3102 in Hypercholesterolemia Patients
- ClinicalTrials.gov ID
- NCT02368613
- Acronym / sponsor ID
- DW-3102_201
- Conditions
- Hypercholesterolemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Primary completion
- Oct 2017 (estimated)
- First posted
- 23 Feb 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 adequate-dose of DW-3102 in the treatment of hypercholesterolemia patients by conducting phase 2a. 4 groups involving placebo group, each groups are composed by 16, will be participated in this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo group | Placebo comparator | Drug: DW-3102Placebo |
| test1 group | Active comparator | Drug: DW-3102DW-3102 125mg |
| test2 group | Active comparator | Drug: DW-3102DW-3102 250mg |
| test3 group | Active comparator | Drug: DW-3102DW-3102 500mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- More than 19 years old
- Those who meet the fasting serum lipid levels along table
- Those who are under 350 mg/dL of TG level when fasting
Key exclusion criteria (16 listed)
- The patient of acute arterial disease
- The patient of severe heart failure(NYHA class III or IV)
- Within the last 6 months clinically meaningful treatment that requires that arrhythmias or cardiac conduction disorders
- Uncontrolled hypertension ( systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 110mmHg or more later)
- Endocrine or metabolic disease patients known to affect serum lipids or lipoproteins
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-3102 | Drug | placebo group, test1 group, test2 group, test3 group |
Primary outcome
The change of LDL-C%
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DW-3102 in people with Hypercholesterolemia, run by Daewon Pharmaceutical Co., Ltd..
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 16 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 10 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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 change of LDL-C% (time frame: 6 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.