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OpenTrials
Completed

NCT Number: NCT02390375

Phase 3 Study to Evaluate the Efficacy and Safety of the DW0929 in Patients With Primary Hypercholesterolemia

The purpose of this study is to evaluate the efficacy and safety of the DW0929 in patients with primary hypercholesterolemia

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Boramae Hospital

Seoul, Dongjak-gu, 156-707, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult over 19years
  • Patients with primary hypercholesterolemia whose LDL-C level is below 250mg/dL and TG level is below 350mg/dL
  • Patients whose LDL-C level is under 'Anti- dyslipidemia drug administration considered standard' of NCEP ATP III(2004)
  • Those who voluntarily written consent to participate in this clinical trial

Exclusion criteria

  • Uncontrolled hypertension
  • Severe renal impairment(CrCl<30mL/min)
  • Those who have active liver disease and whose ALT, AST levels greater than twice the upper limit of normal
  • Serum creatinine > 2.0mg/dL
  • Those who have been geunyukbyeong or rhabdomyolysis caused by using statin or have hypersensitivity to ezetimibe
  • Combined cyclosporine -treated patients
  • HbA1c ≥ 9%
  • TSH ≥ 1.5 X ULN
  • HIV-positive person
  • Congestive heart failure patients classified as NYHA Class III or IV
  • Patients with uncontrolled arrhythmias
  • Patients who have malignant tumors needed chemotherapy, radiation therapy, etc.
  • Blood clotting disorders
  • Patients who had a myocardial infarction within 6 months or cardiovascular bypass surgery, patients who have underwent angioplasty
  • Patients who had a history of anxiety or severe typical peripheral arterial disease within three months
  • Women of childbearing age who don't agree with contraception during this clinical trials
  • Pregnant women or nursing mothers
  • Those who take the drug in combination taboo
  • Who have been treated for another investigational drug within 30 days
  • Unsuitable characters in a clinical trial to test self- determination

Treatment and study plan

DW-0929

Drug

5/10mg

Rosuvastatin

Drug

5mg F/U study: DW-0929 5/10mg

Primary outcomes

  1. LDL-C level

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2015
Registry last updated
Oct 10, 2016

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.

Published trials that share one or more normalized conditions with this study.