Phase 3 Study to Evaluate the Efficacy and Safety of the DW0929 in Patients With Primary Hypercholesterolemia
1 other identifier
interventional
348
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of the DW0929 in patients with primary hypercholesterolemia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 11, 2015
CompletedFirst Posted
Study publicly available on registry
March 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedOctober 10, 2016
October 1, 2016
1.4 years
March 11, 2015
October 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
LDL-C level
8 weeks
Study Arms (2)
A
EXPERIMENTALDW-0929
B
ACTIVE COMPARATORRosuvastatin
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boramae Hospital
Seoul, Dongjak-gu, 156-707, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2015
First Posted
March 17, 2015
Study Start
November 1, 2014
Primary Completion
April 1, 2016
Study Completion
May 1, 2016
Last Updated
October 10, 2016
Record last verified: 2016-10