NCT00240305

Brief Summary

The purpose of this study is to investigate the dose-related effect of treatment with rosuvastatin on production and fractional catabolism of apolipoprotein A-I (apoA-I) and apolipoprotein A-II (apoA-II), and on the plasma apoA-I, apoA-II and high-density lipoprotein cholesterol (HDL-C) concentration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2004

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

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

March 16, 2009

Status Verified

March 1, 2009

First QC Date

October 16, 2005

Last Update Submit

March 13, 2009

Conditions

Metabolic SyndromeDyslipidemia

Keywords

Metabolic SyndromeDyslipidaemia

Outcome Measures

Primary Outcomes (1)

  • Determine the dose-related effect of treatment with rosuvastatin on production & fractional catabolism of apolipoprotein A-I (apoA-I) and apolipoprotein A-II (apoA-II), & on the plasma apoA-I, apoA-II & high-density lipoprotein cholesterol (HDL-C) c

Secondary Outcomes (3)

  • Determine the dose-related effect of treatment with rosuvastatin on cellular cholesterol efflux,total cholesterol, low-density lipoprotein cholesterol (LDL-C), non-LDL-C, triglyceride & pre1-HDL concentrations,HDL2,HDL3 cholesterol ratio

  • Cholesteryl ester transfer protein (CETP) and lecithin:cholesterol acyl transferase (LCAT) activity

  • Lathosterol and campesterol, total apolipoprotein B (apoB), nonesterified fatty acids (NEFA) and apolipoprotein C-III (apoC-III) plasma concentrations.

Interventions

RosuvastatinDRUG

Eligibility Criteria

Age30 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • male aged 30 to 70 years of age
  • LDL-C \<6 mmol/L
  • HDL-C ≤1.2 mmol/L
  • at least 2 of the following:
  • insulin resistance (fasting glucose \>6 mmol/L or insulin \>10 mU/L or HOMA score \>2.5)
  • central obesity (waist circumference \>=94 cm).
  • plasma triglycerides \>=1.7 and \<4.5 mmol/L.
  • blood pressure \>=130/ \>=85 mm Hg or on drug treatment for hypertension

You may not qualify if:

  • LDL cholesterol \>=6 mmol/L
  • pre-existing or history of cardiovascular disease, diabetes, renal dysfunction, anaemia, history of significant dyspepsia or gastrointestinal disease
  • apolipoprotein genotype E2/E2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Perth, Western Australia, Australia

Location

Related Publications (4)

  • Ng TW, Ooi EM, Watts GF, Chan DC, Meikle PJ, Barrett PH. Association of Plasma Ceramides and Sphingomyelin With VLDL apoB-100 Fractional Catabolic Rate Before and After Rosuvastatin Treatment. J Clin Endocrinol Metab. 2015 Jun;100(6):2497-501. doi: 10.1210/jc.2014-4348. Epub 2015 Mar 27.

    PMID: 25816050DERIVED

  • Ng TW, Ooi EM, Watts GF, Chan DC, Weir JM, Meikle PJ, Barrett PH. Dose-dependent effects of rosuvastatin on the plasma sphingolipidome and phospholipidome in the metabolic syndrome. J Clin Endocrinol Metab. 2014 Nov;99(11):E2335-40. doi: 10.1210/jc.2014-1665. Epub 2014 Aug 20.

    PMID: 25140396DERIVED

  • Ooi EM, Watts GF, Chan DC, Chen MM, Nestel PJ, Sviridov D, Barrett PH. Dose-dependent effect of rosuvastatin on VLDL-apolipoprotein C-III kinetics in the metabolic syndrome. Diabetes Care. 2008 Aug;31(8):1656-61. doi: 10.2337/dc08-0358. Epub 2008 May 28.

    PMID: 18509206DERIVED

  • Ooi EM, Barrett PH, Chan DC, Nestel PJ, Watts GF. Dose-dependent effect of rosuvastatin on apolipoprotein B-100 kinetics in the metabolic syndrome. Atherosclerosis. 2008 Mar;197(1):139-46. doi: 10.1016/j.atherosclerosis.2007.03.004. Epub 2007 Apr 9.

    PMID: 17416370DERIVED

MeSH Terms

Conditions

Metabolic SyndromeDyslipidemias

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Gerald F. Watts, BSc PhD MD

    University Department of Medicine, Royal Perth Hospital, University of Western Australia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 16, 2005

First Posted

October 18, 2005

Study Start

April 1, 2004

Study Completion

May 1, 2006

Last Updated

March 16, 2009

Record last verified: 2009-03

Locations

AU(1)