HyperlipidemiaPhase 3NCT02799758
Efficacy & Long-term Safety Comparison Study of NK-104-CR & Livalo® IR With Primary Hyperlipidemia or Mixed Dyslipidemia
A Phase 3 study testing NK-104-CR and Livalo® IR in people with Hyperlipidemia and Dyslipidemia, run by Kowa Research Institute, Inc. at 69 sites in United States.
Trial summary
The purpose of this study is to demonstrate the superior efficacy of NK-104-CR 8 mg daily compared to Livalo® IR 4 mg daily on fasting serum low-density lipoprotein cholesterol (LDL-C) reduction and to evaluate the comparative safety of NK-104-CR 8 mg daily to Livalo® IR 4 mg daily after long-term treatment 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® IR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 69 sitesUnited States
- Study dates
- Feb 2016to Nov 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
- Patients for whom lipid-lowering therapy is indicated according to NCEP ATPIII
- Patients who are naïve to statin or who are able to safely discontinue the use of all lipid-lowering agents for 4 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 >9%
Trial locations and contacts
69 sites in 1 country.
69 sites in 1 country
United States69 sites
Study site
Addison, Illinois
Study site
Atlantis, Florida
Study site
Austin, Texas
Study site
Beaver, Pennsylvania
Study site
Biloxi, Mississippi
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Columbus, Ohio
Study site
Cooper City, Florida
Study site
Coral Springs, Florida
Study site
Dawsonville, Georgia
Study site
Evansville, Indiana
Study site
Fargo, North Dakota
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Fleming Island, Florida
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Foley, Alabama
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Franklin, Ohio
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Greenbrae, California
Study site
Gurnee, Illinois
Study site
Harleysville, Pennsylvania
Study site
High Point, North Carolina
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Houston, Texas
Study site
Huntington Park, California
Study site
Huntsville, Alabama
Study site
Jacksonville, Florida
Study site
Jefferson City, Missouri
Study site
Jersey Shore, Pennsylvania
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Katy, Texas
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Kenosha, Wisconsin
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Little Rock, Arkansas
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Lomita, California
Study site
Long Beach, California
Study site
Los Angeles, California
Study site
Louisville, Kentucky
Study site
Macon, Georgia
Study site
Manlius, New York
Study site
Medford, Oregon
Study site
Miami, Florida
Study site
Milford, Connecticut
Study site
Moncks Corner, South Carolina
Study site
Montgomery, Alabama
Study site
Morton, Illinois
Study site
Muscle Shoals, Alabama
Study site
Oklahoma City, Oklahoma
Study site
Olive Branch, Mississippi
Study site
Omaha, Nebraska
Study site
Oviedo, Florida
Study site
Owensboro, Kentucky
Study site
Oxon Hill, Maryland
Study site
Philadelphia, Pennsylvania
Study site
Pittsburgh, Pennsylvania
Study site
Plano, Texas
Study site
Richmond, Virginia
Study site
Round Rock, Texas
Study site
Salisbury, North Carolina
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
Santa Ana, California
Study site
Seattle, Washington
Study site
Simpsonville, South Carolina
Study site
Spring Valley, California
Study site
St Louis, Missouri
Study site
Suffolk, Virginia
Study site
Summerville, South Carolina
Study site
Suwanee, Georgia
Study site
Topeka, Kansas
Study site
Tustin, California
Study site
Walnut Creek, California
Study site
Wilmington, North Carolina
Study site
Winston-Salem, North Carolina
About this study
The purpose of this study is to demonstrate the superior efficacy of NK-104-CR 8 mg daily compared to Livalo® IR 4 mg daily on fasting serum low-density lipoprotein cholesterol (LDL-C) reduction and to evaluate the comparative safety of NK-104-CR 8 mg daily to Livalo® IR 4 mg daily after long-term treatment
- Conditions
- Hyperlipidemia, Dyslipidemia
- Being tested
- NK-104-CR, Livalo® IR, Placebo (for NK-104-CR), Placebo (for Livalo® IR)
- 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 for 52 weeks
Livalo® IRDrug
Livalo® IR 4 mg daily for 52 weeks
Placebo (for NK-104-CR)Drug
NK-104-CR 8 mg placebo for 52 weeks
Placebo (for Livalo® IR)Drug
Livalo® IR 4 mg placebo for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| NK-104-CR | Experimental | NK-104-CR 8 mg tablet and Placebo (for Livalo® IR 4 mg tablet) orally once daily for 52 weeks. Receives: Drug: NK-104-CR; Drug: Placebo (for Livalo® IR) |
| Livalo® IR | Active comparator | Livalo® IR 4 mg tablet and Placebo (for NK-104-CR 8 mg tablet) orally once daily for 52 weeks. Receives: Drug: Livalo® IR; Drug: Placebo (for NK-104-CR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in Low-density lipoprotein cholesterol (LDL-C)
Measured: Baseline to Week 12 endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2017 (estimated)
- Study completionNov 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
- NCT02799758
- Sponsor's protocol ID
- NK-104-CR-3.02US
- Status last verified
- May 2021
- First submitted
- 10 Jun 2016
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- 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
- Efficacy & Long-term Safety Comparison Study of NK-104-CR & Livalo® IR With Primary Hyperlipidemia or Mixed Dyslipidemia
- ClinicalTrials.gov ID
- NCT02799758
- Acronym / sponsor ID
- NK-104-CR-3.02US
- 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
- Feb 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 15 Jun 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 demonstrate the superior efficacy of NK-104-CR 8 mg daily compared to Livalo® IR 4 mg daily on fasting serum low-density lipoprotein cholesterol (LDL-C) reduction and to evaluate the comparative safety of NK-104-CR 8 mg daily to Livalo® IR 4 mg daily after long-term treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NK-104-CR | Experimental | Drug: NK-104-CR, Drug: Placebo (for Livalo® IR)NK-104-CR 8 mg tablet and Placebo (for Livalo® IR 4 mg tablet) orally once daily for 52 weeks. |
| Livalo® IR | Active comparator | Drug: Livalo® IR, Drug: Placebo (for NK-104-CR)Livalo® IR 4 mg tablet and Placebo (for NK-104-CR 8 mg tablet) orally once daily for 52 weeks. |
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
- Patients for whom lipid-lowering therapy is indicated according to NCEP ATPIII
- Patients who are naïve to statin or who are able to safely discontinue the use of all lipid-lowering agents for 4 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 >9%
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 for 52 weeks | Drug | NK-104-CR |
| Livalo® IRLivalo® IR 4 mg daily for 52 weeks | Drug | Livalo® IR |
| Placebo (for NK-104-CR)NK-104-CR 8 mg placebo for 52 weeks | Drug | Livalo® IR |
| Placebo (for Livalo® IR)Livalo® IR 4 mg placebo for 52 weeks | Drug | NK-104-CR |
Primary outcome
Percent change in Low-density lipoprotein cholesterol (LDL-C)
Time frame: Baseline to Week 12 endpoint
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.
69 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® IR in people with Hyperlipidemia and Dyslipidemia, run by Kowa Research Institute, Inc. at 69 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 69 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. 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 Low-density lipoprotein cholesterol (LDL-C) (time frame: Baseline to Week 12 endpoint). 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; AzTrials last refreshed its copy on 6 Nov 2026.