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OpenTrials
Completed

NCT Number: NCT03026933

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.

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Key information

Conditions

Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KI1107 4 Capsules, QD

Drug

KI1107 4 Capsules

Rosuvastatin Calcium 20 MG, QD

Drug

Rosuvastatin Calcium 20mg, QD

Primary outcomes

  1. Variation rate of Non HDL-C

    Time frame: 8 weeks

Secondary outcomes

  1. Variation rate of TG

    Time frame: 4 weeks, 8 weeks

  2. Variation rate of Non HDL-C

    Time frame: 4 weeks

  3. Variation rate of TC

    Time frame: 4 weeks, 8 weeks

  4. Variation rate of LDL-C

    Time frame: 4 weeks, 8 weeks

  5. Variation rate of VLDL-C

    Time frame: 4 weeks, 8 weeks

  6. Variation rate of Apo A-I

    Time frame: 4 weeks, 8 weeks

  7. Variation rate of Apo B

    Time frame: 4 weeks, 8 weeks

Sponsors and collaborators

Lead sponsor

Kuhnil Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Acronym: ROMANTIC

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 20, 2017
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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