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Completed

NCT Number: NCT02205606

Efficacy/Safety of HCP1306 Tablet Versus HGP0816 Tablet in Patients With Primary Hypercholesterolemia

The purpose of this study is to evaluate efficacy and safety of HCP1306 in patients with primary hypercholesterolemia.

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Key information

Conditions

Primary Hypercholesterolemia

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

19 institutions including Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged over 19 years
  • Signed informed consent
  • At visit 1, LDL-C ≤ 250mg/dL and Triglyceride < 400 mg/dL
  • After 4 weeks more TLC, At visit2, LDL-C ≤ 250mg/dL, Triglyceride < 400 mg/dL and satisfied criteria according to Risk of cardiovascular disease

Exclusion criteria

  • Current or past history of hypersensitivity to HMG-CoA reductase inhibitors and component of Ezetimibe
  • Has an active liver disease and severe liver disorder (continous elevation of AST, ALT level or exceeds more than 3 times of normal upper limit)
  • Has a severe renal failure and kidney injury (Creatinine level exceeds more than 2 times of normal upper limit)
  • CK level exceeds more than 5 times of normal upper limit
  • Uncontrolled hypertension patient (SBP≥ 180 mmHg or DBP ≥ 110 mmHg)
  • Uncontrolled diabetes mellitus patient (HbA1c ≥ 9%)
  • Uncontrolled malfunctional thyroidism (or at pre-visit 2, TSH level exceeds more than 1.5 times of normal upper limit)

Treatment and study plan

HGP0816 5mg

Drug

P.O.

HGP0816 10mg

Drug

P.O.

HGP0816 20mg

Drug

P.O.

HCP1306 5/10mg

Drug

P.O.

HCP1306 10/10mg

Drug

P.O.

HCP1306 20/10mg

Drug

P.O.

Primary outcomes

  1. Percent change from baseline to 8 week in LDL-Cholesterol

    Time frame: baseline and 8 week

Secondary outcomes

  1. Percent change from baseline to 4 week in LDL-Cholesterol

    Time frame: baseline and 4 week

  2. Percentage of patients reaching treatment goals according to NCEP ATP III Guideline

    Time frame: week 4, week 8

  3. Percent change from baseline to 4 week and 8 week in TC

    Time frame: week 4, week 8

  4. Percent change from baseline to 4 week and 8 week in HDL-C

    Time frame: week 4, week 8

  5. Percent change from baseline to 4 week and 8 week in TG

    Time frame: week 4, week 8

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A Randomized, Double-Blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of HCP1306 Tablet in Patients With Primary Hypercholesterolemia

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 31, 2014
Registry last updated
Sep 22, 2015

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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