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

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DW-0929
DW-0929
DW-0929
Rosuvastatin
Rosuvastatin
Rosuvastatin
Sponsored by
Daewon Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boramae Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

DW-0929

Rosuvastatin

Outcomes

Primary Outcome Measures

LDL-C level

Secondary Outcome Measures

Full Information

First Posted
March 11, 2015
Last Updated
October 7, 2016
Sponsor
Daewon Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02390375
Brief Title
Phase 3 Study to Evaluate the Efficacy and Safety of the DW0929 in Patients With Primary Hypercholesterolemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewon Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
348 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
DW-0929
Arm Title
B
Arm Type
Active Comparator
Arm Description
Rosuvastatin
Intervention Type
Drug
Intervention Name(s)
DW-0929
Intervention Description
5/10mg
Intervention Type
Drug
Intervention Name(s)
DW-0929
Intervention Description
10/10mg
Intervention Type
Drug
Intervention Name(s)
DW-0929
Intervention Description
20/10mg
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
5mg F/U study: DW-0929 5/10mg
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
10mg F/U study: DW-0929 10/10mg
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
20mg F/U study: DW-0929 20/10mg
Primary Outcome Measure Information:
Title
LDL-C level
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Boramae Hospital
City
Seoul
State/Province
Dongjak-gu
ZIP/Postal Code
156-707
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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