DyslipidemiasPhase 3NCT03482180
Evaluate the Efficacy and Safety of KI1106 in Patients Whose TG Level is Not Adequately Controlled With Atorvastatin Calcium Monotherapy While LDL-C is Properly Controlled
A Phase 3 study testing KI1106 4g, QD and Atorvastatin Calcium 20mg, QD in people with Dyslipidemias, run by Kuhnil Pharmaceutical Co., Ltd..
Trial summary
To examine variation rate of Non-HDL with KI1106 comparison Atorvastatin monotherapy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- KI1106 4g, QD and Atorvastatin Calcium 20mg, QD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- No sites listed yet
- Study dates
- 4 May 2016to 23 Mar 2018
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Screening Visit
- Age: 20-80
- High risk for cardiovascular disease according to NCEP APT III
- TG≥300mg/dL and 160mg/dL>LDL-C≥100mg/dL for subjects who were not taking statins for 4 weeks
- 500mg/dL>TG≥200mg/dL and LDL-C<110mg/dL for subjects who were taking statins for 4 weeks
- Baseline Visit
Show all 9Show fewer
- 500mg/dL>TG≥200mg/dL
- LDL-C<110mg/dL
- Reduction of LDL-C comparing screening visit
Who cannot join
- The patient has histories of acute artery disease within 3 months
- The patient has histories of operation revasculariation or aneurysm within 6 months
- The patient has histories of unexplained myalgia or diagnosed myalgia or rhabdomyolysis
- The patient has histories of effect able disease to the procedure and clinical trial result
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Parallel Phase III Study to Evaluate the Efficacy and Safety of KI1106 in Patients Whose TG Level is Not Adequately Controlled With Atorvastatin Calcium Monotherapy While LDL-C is Properly Controlled
To examine variation rate of Non-HDL with KI1106 comparison Atorvastatin monotherapy.
Read the detailed description
Randomly assigned to two groups (KI1106 or Atorvastatin monotherapy) after 4 weeks run-in period and prescribed KI1106 or Atorvastatin for 8 weeks.
- Conditions
- Dyslipidemias
- Being tested
- KI1106 4g, QD, Atorvastatin Calcium 20mg, QD
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KI1106 4g, QDDrug
KI1106 4 Capsules
Atorvastatin Calcium 20mg, QDDrug
Atorvastatin Calcium 20mg
| Study group | Role | What they receive |
|---|---|---|
| Investigational Group- KI1106 | Experimental | KI1106 tablet - daily administration Receives: Drug: KI1106 4g, QD |
| Control Group - Atorvastatin | Active comparator | Atorvastatin Calcium 20mg - daily administration Receives: Drug: Atorvastatin Calcium 20mg, QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation rate of Non HDL-C
Measured: 8 weeks
Secondary outcomes (7)
Variation rate of TG
Measured: 4 weeks, 8 weeks
Variation rate of Non HDL-C
Measured: 4 weeks
Variation rate of TC
Measured: 4 weeks, 8 weeks
Variation rate of LDL-C
Measured: 4 weeks, 8 weeks
Variation rate of VLDL-C
Measured: 4 weeks, 8 weeks
Variation rate of Apo A-I
Measured: 4 weeks, 8 weeks
Variation rate of Apo B
Measured: 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start4 May 2016
- Primary completion16 May 2017
- Study completion23 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuhnil Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- kyungshun Shin, Dr, Study director, manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482180
- Sponsor's protocol ID
- 12-OA-8301
- Status last verified
- Mar 2018
- First submitted
- 23 Mar 2018
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Parallel Phase III Study to Evaluate the Efficacy and Safety of KI1106 in Patients Whose TG Level is Not Adequately Controlled With Atorvastatin Calcium Monotherapy While LDL-C is Properly Controlled
- ClinicalTrials.gov ID
- NCT03482180
- Acronym / sponsor ID
- 12-OA-8301
- Conditions
- Dyslipidemias
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Kuhnil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 May 2016 (actual)
- Primary completion
- 16 May 2017 (actual)
- Study completion
- 23 Mar 2018 (actual)
- First posted
- 29 Mar 2018 (actual)
- 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.
To examine variation rate of Non-HDL with KI1106 comparison Atorvastatin monotherapy.
Detailed description
Randomly assigned to two groups (KI1106 or Atorvastatin monotherapy) after 4 weeks run-in period and prescribed KI1106 or Atorvastatin for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Group- KI1106 | Experimental | Drug: KI1106 4g, QDKI1106 tablet - daily administration |
| Control Group - Atorvastatin | Active comparator | Drug: Atorvastatin Calcium 20mg, QDAtorvastatin Calcium 20mg - daily administration |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Screening Visit
- Baseline Visit
Key exclusion criteria (4 listed)
- The patient has histories of acute artery disease within 3 months
- The patient has histories of operation revasculariation or aneurysm within 6 months
- The patient has histories of unexplained myalgia or diagnosed myalgia or rhabdomyolysis
- The patient has histories of effect able disease to the procedure and clinical trial result
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 |
|---|---|---|
| KI1106 4g, QDKI1106 4 Capsules | Drug | Investigational Group- KI1106 |
| Atorvastatin Calcium 20mg, QDAtorvastatin Calcium 20mg | Drug | Control Group - Atorvastatin |
Primary outcome
Variation rate of Non HDL-C
Time frame: 8 weeks
7 secondary outcomes
Variation rate of TG
Time frame: 4 weeks, 8 weeks
Variation rate of Non HDL-C
Time frame: 4 weeks
Variation rate of TC
Time frame: 4 weeks, 8 weeks
Variation rate of LDL-C
Time frame: 4 weeks, 8 weeks
Variation rate of VLDL-C
Time frame: 4 weeks, 8 weeks
Variation rate of Apo A-I
Time frame: 4 weeks, 8 weeks
Variation rate of Apo B
Time frame: 4 weeks, 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 19 Nov 2018.
- Individual participant dataSharing planned: No
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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.
kyungshun Shin, Dr study director
manager
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KI1106 4g, QD and Atorvastatin Calcium 20mg, QD in people with Dyslipidemias, run by Kuhnil 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 9 inclusion and 4 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 19 Nov 2018. 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. 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?
Variation rate of Non HDL-C (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 19 Nov 2018.