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 (ROMANTIC)

January 19, 2017 updated by: Kuhnil Pharmaceutical Co., Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

215

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • 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

    • 500mg/dL>TG≥200mg/dL
    • LDL-C<110mg/dL
    • Reduction of LDL-C dompairng screening visit

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
KI1107
Drug: KI1107 4 Capsules, QD
KI1107 4 Capsules
Active Comparator: Control
Rosuvastatin calcium
Drug: Rosuvastatin Calcium 20 MG, QD
Rosuvastatin Calcium 20mg, QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variation rate of Non HDL-C
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Variation rate of TG
Time Frame: 4 weeks, 8 weeks
4 weeks, 8 weeks
Variation rate of Non HDL-C
Time Frame: 4 weeks
4 weeks
Variation rate of TC
Time Frame: 4 weeks, 8 weeks
4 weeks, 8 weeks
Variation rate of LDL-C
Time Frame: 4 weeks, 8 weeks
4 weeks, 8 weeks
Variation rate of VLDL-C
Time Frame: 4 weeks, 8 weeks
4 weeks, 8 weeks
Variation rate of Apo A-I
Time Frame: 4 weeks, 8 weeks
4 weeks, 8 weeks
Variation rate of Apo B
Time Frame: 4 weeks, 8 weeks
4 weeks, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuhnil Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

January 16, 2017

First Submitted That Met QC Criteria

January 19, 2017

First Posted (Estimate)

January 20, 2017

Study Record Updates

Last Update Posted (Estimate)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-OR-8301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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