| Trial ID: | L0483 |
| Source ID: | NCT01564875
|
| Associated Drug: |
Simvast Cr
|
| Title: |
Efficacy and Safety of Simvast Controlled Release (CR) and Zocor in Chronic Kidney Disease(CKD) Stage 3, 4 and 5 Patients With Hyperlipidemia
|
| Acronym: |
HM-SIM4
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease|Hyperlipidemia
|
| Interventions: |
DRUG: Simvast CR|DRUG: Zocor
|
| Outcome Measures: |
Primary: Percent change of LDL-C, Percent change of LDL-C at Week 8 from baseline, 8 weeks | Secondary: Change and percent change of TC, HDL-C, TG, Change and percent change of TC, HDL-C, TG from baseline., 8 weeks|Accomplishment rate of therapeutic goals, -Accomplishment rate of therapeutic goals based on the therapeutic guidance for hyperlipidemia of the Korean Society of Lipidology and Atherosclerosis., 8 weeks
|
| Sponsor/Collaborators: |
Sponsor: Hanmi Pharmaceutical Company Limited
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
122
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-12
|
| Completion Date: |
2012-05
|
| Results First Posted: |
|
| Last Update Posted: |
2012-03-28
|
| Locations: |
Hallym University Medical Center, Anyang-si, Gyeonggi-do, Korea, Republic of|Inje University Ilsan Paik Hospital, Goyang-si, Gyeonggi-do, Korea, Republic of|Gachon University Gil Hospital, Incheon, Korea, Republic of|Eulji General Hospital, Seoul, Korea, Republic of|Hanyang University Seoul Hospital, Seoul, Korea, Republic of|Korea University Anam Hospital, Seoul, Korea, Republic of|Seoul National University Hospital, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT01564875
|
