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Efficacy and Safety of Simvast Controlled Release (CR) and Zocor in Chronic Kidney Disease(CKD) Stage 3, 4 and 5 Patients With Hyperlipidemia

NCT01564875 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2012-03-28

No results posted yet for this study

Summary

Study design

* Multicenter, double-dummy, double-blinded, randomized, Phase 4 study
* Patients will be randomized to either a study group or a control group in a 1:1 ratio, and will be orally administered the assigned drugs

Study Objective

-The study is designed to demonstrate that efficacy and safety of morning dosing of Simvast Controlled Release (CR) Tab is not inferior to evening dosing of Zocor Tab in patients with stage 3,4,5 chronic kidney disease with hyperlipidemia

Primary objective

-to assess the percent change of LDL-C at Week 8 from baseline in Chronic Kidney Disease(CKD) stage 3,4,5 with hyperlipidemia subjects.

Conditions

Interventions

DRUG

Simvast CR

Simvast CR Tab 20mg, 1 tablet once daily to be administered between 6 and 9 a.m.

DRUG

Zocor

Zocor Tab 20mg, 1 tablet once daily to be administered between 6 and 9 p.m.

Sponsors & Collaborators

  • Hanmi Pharmaceutical Company Limited

    lead INDUSTRY

Principal Investigators

  • Kyung-mi Park, Ph.D · Hanmi Pharmaceutical Company Limited ( e-mail: [email protected] )

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01564875 on ClinicalTrials.gov