NCT01414803

Brief Summary

Although the combination of statin and fenofibrate is one of the options for patients with combined hyperlipidemia, non-lipid effects of it has not been completely understood yet. In this study we compared the effects of rosuvastatin 10 mg/fenofibrate 160 mg combination and rosuvastatin 10 mg monotherapy on muscle and liver enzyme, homocysteine levels, kidney, blood glucose control, and blood cell counts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2009

Typical duration for phase_4

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

March 1, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
Last Updated

August 11, 2011

Status Verified

August 1, 2011

Enrollment Period

2.1 years

First QC Date

August 3, 2011

Last Update Submit

August 10, 2011

Conditions

Hyperlipidemia

Keywords

rosuvastatin, fenofibrate, creatine kinase, alanine aminotransferase

Outcome Measures

Primary Outcomes (1)

  • Incidence of elevation of CK>5x ULN or AST>3x ULN or ALT>3x ULN

    24 weeks after drug treatment

Study Arms (2)

rosuvastatin/fenofibrate combination

EXPERIMENTAL

rosuvastatin 10 mg/fenofibrate 160 mg per day

Drug: Lipid modification

rosuvastatin monotherapy

ACTIVE COMPARATOR

rosuvastatin 10 mg per day

Drug: Lipid modification

Interventions

Lipid modificationDRUG

rosuvastatin 10 mg/fenofibrate 160 mg per day

rosuvastatin/fenofibrate combination

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mixed hyperlipidemia: total cholesterol levels higher than 220 mg/dL, triglyceride (TG) levels between 200 and 500 mg/dL, and low-density lipoprotein (LDL)-cholesterol levels higher than 130 mg/dL after 6-week diet/life style change
  • Men and women who were between 20 and 70 years of age
  • Having at least one history of: coronary artery disease, cerebrovascular disease or transient ischemic attack, peripheral vascular disease, or diabetes mellitus.
  • Having risk factors at least two of: age ≥45 years in male or ≥55 years in female, elevated blood pressure (systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg, or treatment of previously diagnosed hypertension), high-density lipoprotein (HDL)-cholesterol \<40 mg/dL, family history of coronary artery disease at age \<55 years in male or \<65 years in female, central obesity (waist circumference ≥90 cm for male or ≥80 cm for female), fasting plasma glucose ≥110 mg/dL, or left ventricular hypertrophy on electrocardiogram
  • Written informed consent.

You may not qualify if:

  • pregnant or breast-feeding
  • uncontrolled hypertension
  • uncontrolled diabetes mellitus
  • thyroid dysfunction
  • serum transaminase level \>2 times the upper limit of normal
  • history of gall bladder disease
  • chronic alcoholic
  • serum creatinine level \>1.5 mg/dL
  • history of myopathy
  • history of acute myocardial infarction or acute stroke within 3 months before the study began
  • acute or chronic infection or inflammation
  • history of cancer
  • history of adverse events associated with test drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (2)

  • Paterson JM, Smith SM, Simpson J, Grace OC, Sosunov AA, Bell JE, Antoni FA. Characterisation of human adenylyl cyclase IX reveals inhibition by Ca(2+)/Calcineurin and differential mRNA plyadenylation. J Neurochem. 2000 Oct;75(4):1358-67. doi: 10.1046/j.1471-4159.2000.0751358.x.

    PMID: 10987815BACKGROUND

  • Lee SH, Cho KI, Kim JY, Ahn YK, Rha SW, Kim YJ, Choi YS, Choi SW, Jeon DW, Min PK, Choi DJ, Baek SH, Kim KS, Byun YS, Jang Y. Non-lipid effects of rosuvastatin-fenofibrate combination therapy in high-risk Asian patients with mixed hyperlipidemia. Atherosclerosis. 2012 Mar;221(1):169-75. doi: 10.1016/j.atherosclerosis.2011.12.042. Epub 2012 Jan 5.

    PMID: 22269152DERIVED

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 3, 2011

First Posted

August 11, 2011

Study Start

March 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

August 11, 2011

Record last verified: 2011-08

Locations

KR(1)