NCT00973115

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 9, 2009

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

1.8 years

First QC Date

September 6, 2009

Last Update Submit

October 10, 2016

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • the percent change from baseline in LDL cholesterol

    week 8

Secondary Outcomes (1)

  • the change and the percent change from baseline for total cholesterol, HDL cholesterol, Triglyceride, apolipoprotein A-I, apolipoprotein B, and lipoprotein(a)

    week 8

Study Arms (2)

Simvastatin CR 20mg- morning administration

EXPERIMENTAL
Drug: Simvastatin CR

Simvastatin CR 20mg- evening administration

ACTIVE COMPARATOR
Drug: Simvastatin CR

Interventions

Simvastatin CRDRUG
Simvastatin CR 20mg- evening administrationSimvastatin CR 20mg- morning administration

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

8 Sites

Seoul, South Korea

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Seong-Hoon Park, M.D., Ph.D

    Ehwa Womans University Mokdong Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 6, 2009

First Posted

September 9, 2009

Study Start

November 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

October 12, 2016

Record last verified: 2016-10

Locations

KR(1)