NCT00831129

Brief Summary

The purpose of this research study is to examine if a combination of a cholesterol lowering-drug, simvastatin, with a sugar-lowering drug called rosiglitazone is more effective in improving vascular inflammation (irritation of the vessels that transport your blood) and other cardiovascular risk factors than the taking of simvastatin alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2006

Typical duration for phase_2

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

September 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

September 12, 2013

Completed
Last Updated

February 10, 2017

Status Verified

December 1, 2016

Enrollment Period

4.5 years

First QC Date

January 26, 2009

Results QC Date

June 27, 2013

Last Update Submit

December 19, 2016

Conditions

Pre-diabetes

Outcome Measures

Primary Outcomes (1)

  • Change in High-sensitivity C-reactive Protein

    change in high-sensitivity C-reactive between baseline and 6 month

    Baseline and 6 months

Secondary Outcomes (15)

  • Change in Urinary Isoprostane

    Baseline and 6 months

  • Change in Malondialdehyde

    Baseline and 6 months

  • Change in Office Systolic Blood Pressure

    Baseline and 6 months

  • Change in Office Diastolic Blood Pressure

    Baseline and 6 months

  • Change in (Ambulatory Blood Pressure Monitoring) Systolic Blood Pressure

    Baseline and 6 months

  • +10 more secondary outcomes

Study Arms (2)

Simvastatin + Placebo Rosiglitazone

ACTIVE COMPARATOR

Subjects will receive 40 mg Simvastatin + 1 tab Placebo Rosiglitazone daily

Drug: Placebo RosiglitazoneDrug: Simvastatin

Simvastatin + rosiglitazone

ACTIVE COMPARATOR

Subjects will receive 40 mg Simvastatin + 4 mg Rosiglitazone once daily

Drug: RosiglitazoneDrug: Simvastatin

Interventions

RosiglitazoneDRUG

4 mg daily

Also known as: Avandia
Simvastatin + rosiglitazone
Placebo RosiglitazoneDRUG

1 tab daily

Also known as: Placebo
Simvastatin + Placebo Rosiglitazone
SimvastatinDRUG

40 mg daily

Also known as: Zocor
Simvastatin + Placebo RosiglitazoneSimvastatin + rosiglitazone

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years
  • Metabolic syndrome (3 of the 5 components)
  • Elevated waist circumference \>40inches in men, \>35inches in women
  • Elevated triglycerides \>150mg/dL
  • Reduced HDL \<40mg/dL in men, \<50mg/dL in women
  • Elevated blood pressure \>130mmHg systolic, \>85mmHg diastolic
  • Elevated fasting glucose \>100mg/dL

You may not qualify if:

  • Diabetes mellitus
  • Stage 3 hypertension \>180mmHg systolic, \>110mmHg diastolic office blood pressure
  • History of non-diabetic kidney disease
  • Myocardial infarction of unstable angina within the past 6 months
  • History of liver disease
  • History of malignancy
  • History of drug or alcohol abuse
  • Treatment with corticosteroids
  • Pregnancy or lactating women of women of child bearing potential who are not willing to use reliable contraception method during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Glucose Intolerance

Interventions

RosiglitazoneSimvastatin

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Dr. George Bakris
Organization
University of Chicago
bbrisky@medicine.bsd.uchicago.edu
773-702-7936

Study Officials

  • George Bakris, M.D.

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2009

First Posted

January 28, 2009

Study Start

September 1, 2006

Primary Completion

March 1, 2011

Study Completion

April 1, 2011

Last Updated

February 10, 2017

Results First Posted

September 12, 2013

Record last verified: 2016-12

Locations

US(1)