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DyslipidemiasPhase 3ROMANTICNCT03026933

Evaluate the Efficacy and Safety of KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin Calcium Monotherapy While LDL-C is Properly Controlled

A Phase 3 study testing KI1107 4 Capsules, QD and Rosuvastatin Calcium 20 MG, QD in people with Dyslipidemias, run by Kuhnil Pharmaceutical Co., Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To examine variation rate of Non-HDL with KI1107 comparison Rosuvastatin monotherapy. Read more about this study

Who is it for?
Ages 19 to 80 years
Conditions the study is for
Dyslipidemias
What is being tested?
KI1107 4 Capsules, QD and Rosuvastatin Calcium 20 MG, 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
May 2014to Mar 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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Screening Visit
  • Age: 19-80
  • High risk for cardiovascular disease according to NCEP APT III
  • TG≥130mg/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 dompairng screening visit

Who cannot join

  • The patient has histories of acute artery disease within 3 months
  • The patient has histories of operation revasculatiation or aneurysm within 6 months
  • The patient has histories of Unexplained myaliga or diagnosed myalgia or rhabdomyolysis
  • The patient has histories of Effectable disease to the procedrue 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 KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin Calcium Monotherapy While LDL-C is Properly Controlled

To examine variation rate of Non-HDL with KI1107 comparison Rosuvastatin monotherapy.

Read the detailed description

Study design:

Randomly assigned to two groups(KI1107 or Rosuvastatin monotherpy) after 4 weeks run-in period and prescribed KI1107 or Rosuvastatin for 8 weeks.

Conditions
Dyslipidemias
Being tested
KI1107 4 Capsules, QD, Rosuvastatin Calcium 20 MG, QD
Medical subject headings
Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KI1107 4 Capsules, QDDrug

    KI1107 4 Capsules

  • Rosuvastatin Calcium 20 MG, QDDrug

    Rosuvastatin Calcium 20mg, QD

Study groups in NCT03026933
Study groupRoleWhat they receive
TreatmentExperimentalKI1107
Receives: Drug: KI1107 4 Capsules, QD
ControlActive comparatorRosuvastatin calcium
Receives: Drug: Rosuvastatin Calcium 20 MG, QD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Variation rate of Non HDL-C

    Measured: 8 weeks

Secondary outcomes (7)

  1. Variation rate of TG

    Measured: 4 weeks, 8 weeks

  2. Variation rate of Non HDL-C

    Measured: 4 weeks

  3. Variation rate of TC

    Measured: 4 weeks, 8 weeks

  4. Variation rate of LDL-C

    Measured: 4 weeks, 8 weeks

  5. Variation rate of VLDL-C

    Measured: 4 weeks, 8 weeks

  6. Variation rate of Apo A-I

    Measured: 4 weeks, 8 weeks

  7. 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.

  1. First posted20 Jan 2017 (estimated)
  2. Study startMay 2014
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03026933
Sponsor's protocol ID
13-OR-8301
Acronym
ROMANTIC
Status last verified
Jan 2017
First submitted
16 Jan 2017
Last updated
20 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Kim CH, Han KA, Yu J, Lee SH, Jeon HK, Kim SH, Kim SY, Han KH, Won K, Kim DB, Lee KJ, Min K, Byun DW, Lim SW, Ahn CW, Kim S, Hong YJ, Sung J, Hur SH, Hong SJ, Lim HS, Park IB, Kim IJ, Lee H, Kim HS. Efficacy and Safety of Adding Omega-3 Fatty Acids in Statin-treated Patients with Residual Hypertriglyceridemia: ROMANTIC (Rosuvastatin-OMAcor iN residual hyperTrIglyCeridemia), a Randomized, Double-blind, and Placebo-controlled Trial. Clin Ther. 2018 Jan;40(1):83-94. doi: 10.1016/j.clinthera.2017.11.007. Epub 2017 Dec 7.

    PubMed 29223557

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KI1107 4 Capsules, QD and Rosuvastatin Calcium 20 MG, 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 20 Jan 2017. 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?

On the ClinicalTrials.gov record for NCT03026933, which also lists 1 linked publication.

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 20 Jan 2017; AzTrials last refreshed its copy on 7 Nov 2026.

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