HyperlipidemiaPhase 3NCT02670434
Safety and Efficacy Comparison Study of NK-104-CR (Controled Release) in Patients With Primary Hyperlipidemia or Mixed Dyslipidemia
A Phase 3 study testing NK-104-CR and Livalo in people with Hyperlipidemia and Dyslipidemia, run by Kowa Research Institute, Inc. at 45 sites in United States.
Trial summary
The purpose of this study is to compare the efficacy of NK-104-CR with Placebo and Livalo® on the reduction of LDL-C and to evaluate the safety of NK-104-CR in patients with primary hyperlipidemia or mixed dyslipidemia Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperlipidemia, Dyslipidemia
- What is being tested?
- NK-104-CR and Livalo
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 45 sitesUnited States
- Study dates
- Jan 2016to Oct 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients with primary hyperlipidemia or mixed dyslipidemia who are ≥18 and ≤80 years of age at the time of consent;
- Fasting plasma LDL-C ≥160 mg/dL and ≤250 mg/dL and TG values of ≤300 mg/dL
- Patients who are naïve to statin or who are able to safely discontinue the use of all lipid-lowering agents for 6 weeks before randomization and throughout study participation
Who cannot join
- Homozygous familial hypercholesterolemia;
- Any conditions which may cause secondary dyslipidemia.
- Newly diagnosed or poorly controlled diabetes mellitus as defined by HbA1c >8%
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
Study site
Auburn, Maine
Study site
Berlin, New Jersey
Study site
Beverly Hills, California
Study site
Brooksville, Florida
Study site
Butte, Montana
Study site
Charleston, South Carolina
Study site
Chicago, Illinois
Study site
Chino, California
Study site
Cincinnati, Ohio
Study site
Downingtown, Pennsylvania
Study site
Edina, Minnesota
Study site
Elkridge, Maryland
Study site
Endwell, New York
Study site
Evanston, Illinois
Study site
Evansville, Indiana
Study site
Fort Lauderdale, Florida
Study site
Greensboro, North Carolina
Study site
Houston, Texas
Study site
Hurst, Texas
Study site
Indianapolis, Indiana
Study site
Jackson, Mississippi
Study site
Jacksonville, Florida
Study site
Jupiter, Florida
Study site
Kettering, Ohio
Study site
Kingsport, Tennessee
Study site
Las Vegas, Nevada
Study site
Lincoln, California
Study site
Los Angeles, California
Study site
Lyndhurst, Ohio
Study site
Madison, Wisconsin
Study site
Marietta, Georgia
Study site
Marion, Ohio
Study site
Meridian, Idaho
Study site
Miami, Florida
Study site
Mt. Pleasant, South Carolina
Study site
Newport Beach, California
Study site
Newton, Kansas
Study site
North Hollywood, California
Study site
Pembroke Pines, Florida
Study site
Port Orange, Florida
Study site
Rochester, New York
Study site
Thousand Oaks, California
Study site
Vista, California
Study site
Wichita, Kansas
Study site
Willoughby Hills, Ohio
About this study
The purpose of this study is to compare the efficacy of NK-104-CR with Placebo and Livalo® on the reduction of LDL-C and to evaluate the safety of NK-104-CR in patients with primary hyperlipidemia or mixed dyslipidemia
- Conditions
- Hyperlipidemia, Dyslipidemia
- Being tested
- NK-104-CR, Placebo, Livalo
- Medical subject headings
- Hyperlipidemias, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK-104-CRDrug
NK-104-CR 8 mg daily for 52 weeks
PlaceboDrug
Placebo daily for 12 weeks
LivaloDrug
Livalo® IR daily from week 12 to week 52
| Study group | Role | What they receive |
|---|---|---|
| NK-104-CR | Experimental | Controlled release NK-104 Receives: Drug: NK-104-CR |
| Placebo | Placebo comparator | Livalo Placebo Receives: Drug: Placebo |
| Livalo® Immediate Release IR | Active comparator | Immediate Release Livalo® Receives: Drug: Livalo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in LDL-C from baseline
Measured: 12 Weeks
Secondary outcomes (1)
The percent change from baseline in fasting serum total cholesterol (TC )
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2017 (estimated)
- Study completionOct 2017 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowa Research Institute, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670434
- Sponsor's protocol ID
- NK-104-CR-3.01US
- Status last verified
- May 2021
- First submitted
- 28 Jan 2016
- Last updated
- 10 May 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Comparison Study of NK-104-CR (Controled Release) in Patients With Primary Hyperlipidemia or Mixed Dyslipidemia
- ClinicalTrials.gov ID
- NCT02670434
- Acronym / sponsor ID
- NK-104-CR-3.01US
- Conditions
- Hyperlipidemia, Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 1 Feb 2016 (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 compare the efficacy of NK-104-CR with Placebo and Livalo® on the reduction of LDL-C and to evaluate the safety of NK-104-CR in patients with primary hyperlipidemia or mixed dyslipidemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NK-104-CR | Experimental | Drug: NK-104-CRControlled release NK-104 |
| Placebo | Placebo comparator | Drug: PlaceboLivalo Placebo |
| Livalo® Immediate Release IR | Active comparator | Drug: LivaloImmediate Release Livalo® |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients with primary hyperlipidemia or mixed dyslipidemia who are ≥18 and ≤80 years of age at the time of consent;
- Fasting plasma LDL-C ≥160 mg/dL and ≤250 mg/dL and TG values of ≤300 mg/dL
- Patients who are naïve to statin or who are able to safely discontinue the use of all lipid-lowering agents for 6 weeks before randomization and throughout study participation
Key exclusion criteria (3 listed)
- Homozygous familial hypercholesterolemia;
- Any conditions which may cause secondary dyslipidemia.
- Newly diagnosed or poorly controlled diabetes mellitus as defined by HbA1c >8%
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 |
|---|---|---|
| NK-104-CRNK-104-CR 8 mg daily for 52 weeks | Drug | NK-104-CR |
| PlaceboPlacebo daily for 12 weeks | Drug | Placebo |
| LivaloLivalo® IR daily from week 12 to week 52 | Drug | Livalo® Immediate Release IR |
Primary outcome
Percent change in LDL-C from baseline
Time frame: 12 Weeks
1 secondary outcome
The percent change from baseline in fasting serum total cholesterol (TC )
Time frame: 12 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
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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.
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NK-104-CR and Livalo in people with Hyperlipidemia and Dyslipidemia, run by Kowa Research Institute, Inc. at 45 sites in United States.
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 3 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: withdrawn, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States. 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. 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 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 was withdrawn before enrolling participants, so there are no results.
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 in LDL-C from baseline (time frame: 12 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 May 2021.