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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02390375
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : October 10, 2016
Sponsor:
Information provided by (Responsible Party):
Daewon Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: DW-0929 Drug: Rosuvastatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : November 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A
DW-0929
Drug: DW-0929
5/10mg

Drug: DW-0929
10/10mg

Drug: DW-0929
20/10mg

Active Comparator: B
Rosuvastatin
Drug: DW-0929
5/10mg

Drug: DW-0929
10/10mg

Drug: DW-0929
20/10mg

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

Drug: Rosuvastatin
10mg F/U study: DW-0929 10/10mg

Drug: Rosuvastatin
20mg F/U study: DW-0929 20/10mg




Primary Outcome Measures :
  1. LDL-C level [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02390375


Locations
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Korea, Republic of
Boramae Hospital
Seoul, Dongjak-gu, Korea, Republic of, 156-707
Sponsors and Collaborators
Daewon Pharmaceutical Co., Ltd.

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Responsible Party: Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02390375    
Other Study ID Numbers: DW-0929_P301
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: October 10, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors