NCT02772640

Brief Summary

The aim of the study is to demonstrate, whether the time of day of administration of the study drug (containing rosuvastatin and ezetimibe) has an impact on the effectiveness of lipid-lowering therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2016

Longer than P75 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, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

2.8 years

First QC Date

March 28, 2016

Last Update Submit

January 29, 2021

Conditions

Hypercholesterolemia

Keywords

HypercholesterolemiaRosuvastatinStatinEzetimibeComplianceCholesterolSecondary preventionCoronary artery diseaseCholesterol absorption inhibitor

Outcome Measures

Primary Outcomes (1)

  • Change in total cholesterol and LDL-Cholesterol

    Change in total cholesterol and LDL-Cholesterol at 6 and 12 weeks of study drug treatment (combination of ezetimibe and rosuvastatin), depending on the time of day of study drug administration

    6 and 12 weeks

Secondary Outcomes (13)

  • Change in HDL-Cholesterol

    6 and 12 weeks

  • Change in triglycerides

    6 and 12 weeks

  • Change in apolipoproteins ApoB, APO AI

    6 and 12 weeks

  • Change in non - HDL-Cholesterol

    6 and 12 weeks

  • Change in sd-LDL-Cholesterol

    6 and 12 weeks

  • +8 more secondary outcomes

Study Arms (2)

Arm I: R+E morning->evening

ACTIVE COMPARATOR

Rosuvastatin and Ezetimibe morning or evening administration: Rosuvastatin (R) plus Ezetimibe (E) administration in the morning (8:00) for 6 weeks. After 6 weeks - intervention - change of the timing of study drug administration to the evening hours (20:00).

Drug: Rosuvastatin and Ezetimibe morning or evening administration

ARM II: R+E evening->morning

ACTIVE COMPARATOR

Rosuvastatin and Ezetimibe evening or morning administration: Rosuvastatin (R) plus Ezetimibe (E) administration in the evening (20:00) for 6 weeks. After 6 weeks - intervention - change of the timing of study drug administration to the morning hours (8:00).

Drug: Rosuvastatin and Ezetimibe morning or evening administration

Interventions

Rosuvastatin and Ezetimibe morning or evening administrationDRUG

Timing of the drug administration: morning -\> evening evening -\> morning

Also known as: Rosuvastatin, Ezetimibe
ARM II: R+E evening->morningArm I: R+E morning->evening

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypercholesterolemia
  • Ineffectiveness of statin monotherapy in the treatment of hypercholesterolemia after at least 6 weeks

You may not qualify if:

  • Active liver disease
  • Unexplained persistent increase in serum transaminase levels, including more than 3 times the upper limit of normal activity of one of them
  • Severe renal impairment (creatinine clearance \<30 ml / min)
  • Myopathy
  • Concomitant treatment with cyclosporine, gemfibrozil
  • Pregnancy
  • Lactation
  • Women of childbearing age not using effective methods of contraception
  • Symptoms of muscle damage after using statins or fibrates in the past.
  • The activity of creatine kinase\> 5 times the upper limit of normal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Department, Dr. A. Jurasz University Hospital

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094, Poland

Location

Related Publications (1)

  • Obonska K, Kasprzak M, Sikora J, Obonska E, Racki K, Gozdzikiewicz N, Krintus M, Kubica J. The impact of the time of drug administration on the effectiveness of combined treatment of hypercholesterolemia with Rosuvastatin and Ezetimibe (RosEze): study protocol for a randomized controlled trial. Trials. 2017 Jul 11;18(1):316. doi: 10.1186/s13063-017-2047-8.

    PMID: 28697767DERIVED

Related Links

MeSH Terms

Conditions

HypercholesterolemiaPatient ComplianceCoronary Artery Disease

Interventions

Rosuvastatin CalciumEzetimibe

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAzetidinesAzetines

Study Officials

  • Jacek Kubica, MD, PhD

    Collegium Medicum w Bydgoszczy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Jacek Kubica MD, PhD.

Study Record Dates

First Submitted

March 28, 2016

First Posted

May 13, 2016

Study Start

March 1, 2016

Primary Completion

January 1, 2019

Study Completion

May 1, 2020

Last Updated

February 2, 2021

Record last verified: 2021-01

Locations

PL(1)