NCT00385658

Brief Summary

This study will investigate the effects of the combination of fluvastatin and fenofibrate on dyslipidemia in comparison to the combination of simvastatin and ezetimibe.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

October 10, 2006

Last Update Submit

February 22, 2017

Conditions

Dyslipidemia

Keywords

Dyslipidemiametabolic syndromefluvastatinfenofibratesimvastatinezetimibe

Outcome Measures

Primary Outcomes (1)

  • High density lipoprotein cholesterol (HDL-C) measured at the end of each study period.

Secondary Outcomes (6)

  • Compared at the end of each treatment period:

  • patients reaching target levels of low density lipoprotein cholesterol (LDL-C) <100mg/dl

  • patients reaching target levels of non-HDL-C <130mg/

  • LDL-C/HDL-C

  • Triglycerides

  • +1 more secondary outcomes

Interventions

Fluvastatin extended release, fenofibrateDRUG
Fixed combination simvastatin/ezetimibeDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent to participate in the study prior to any study procedures.
  • Male or female subjects, age between 18-75 years inclusive.
  • All women of child bearing potential must have a negative pregnancy test
  • Metabolic Syndrome according to the International Diabetes Federation definition:
  • Low plasma HDL-C (Men \< 40 mg/dl ; Women \< 50 mg/dl ).
  • Elevated waist circumference (men ≥ 94 cm, women ≥ 80cm)
  • And one or more of the following criteria:
  • Triglycerides ≥ 150 mg/d.l
  • Raised blood pressure (DBP ≥ 85 mmHg and/or SBP ≥ 130mmHg ) or treated hypertension.
  • Fasting plasma glucose≥ 100mg/dl.
  • Previously diagnosed type 2 diabetes.

You may not qualify if:

  • Dyslipidemia secondary to other causes such as nephrotic syndrome, autoimmune disease.
  • Type 1 diabetes.
  • HbA1c \> 9.5%.
  • Unexplained serum creatine phosphokinase \> 2 x Upper limit of normal.
  • History of myocardial infarction and/or cerebral stroke and/or unstable angina pectoris.
  • Known or suspected contraindications and warnings according to the country specific label for the investigational drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Investigative Centers, Germany

Location

Novartis Pharma AG

Basel, Switzerland

Location

MeSH Terms

Conditions

DyslipidemiasMetabolic Syndrome

Interventions

FenofibrateEzetimibe

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

Fibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPhenyl EthersEthersBenzophenonesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsKetonesAzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharma AG

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2006

First Posted

October 11, 2006

Study Start

August 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations

DE(1)CH(1)