Efficacy and Safety of Morning Versus Evening Intake of Simvast Controlled Release (CR) Tablet in Patients With Hyperlipidemia

October 10, 2016 updated by: Hanmi Pharmaceutical Company Limited

Efficacy and Safety of Morning Versus Evening Intake of Simvast CR Tablet in Patients With Hyperlipidemia: A Randomized, Double-blind, Multicenter Phase 3 Trial

The purpose of this study is to evaluate the efficacy and safety of morning versus evening intake of Simvastatin Controlled Release tablet 20mg for 8 weeks in patients with hyperlipidemia. This study will investigate equivalence of the low-density lipoprotein(LDL) cholesterol percent change.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged between 19 and 75
  • Defined as a fasting 100mg/dl≤ LDL cholesterol <220mg/dl and triglyceride level<400 mg/dl
  • Need drug therapy by NCEP ATP III guideline
  • Signed informed consent

Exclusion Criteria:

  • Has a hypersensitivity to HMG-CoA reductase inhibitor or simvastatin
  • Has a presence or history of alcohol abuse or drug abuse
  • Active gallbladder disease within 12 months
  • Pancreatitis or Hepatic dysfunction (ALT or AST levels > 2XUNL)
  • HbA1c≥ 9% in type 2 diabetes mellitus patients
  • SBP < 90mmHg or > 160mmHg
  • DBP < 50mmHg or > 100mmHg
  • Myocardial infarction or revascularization procedure within 6 months
  • Has significant cardiovascular disease
  • Malignant tumor within 5years
  • Has fibromyalgia, myopathy, rhabdomyolysis or acute myalgia
  • Uric acid level > 9 mg/dl
  • Thyroid stimulating hormone ≥ 2XUNL
  • Active peptic ulcer disease
  • CPK levels > 3XUNL
  • creatinine level > 2 mg/dl
  • Negative pregnancy test for women of childbearing age and agreement to use contraception while on study
  • Had participated other clinical trial within 4 weeks
  • Need systemic administration of corticosteroids intermittently

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Simvastatin CR 20mg- morning administration
Drug: Simvastatin CR
Active Comparator: Simvastatin CR 20mg- evening administration
Drug: Simvastatin CR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the percent change from baseline in LDL cholesterol
Time Frame: week 8
week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
the change and the percent change from baseline for total cholesterol, HDL cholesterol, Triglyceride, apolipoprotein A-I, apolipoprotein B, and lipoprotein(a)
Time Frame: week 8
week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Investigators

  • Principal Investigator: Seong-Hoon Park, M.D., Ph.D, Ehwa Womans University Mokdong Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

September 6, 2009

First Submitted That Met QC Criteria

September 8, 2009

First Posted (Estimate)

September 9, 2009

Study Record Updates

Last Update Posted (Estimate)

October 12, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-SIM-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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