NCT00473655

Brief Summary

The primary purpose of this trial is to determine if the treatment with rosuvastatin 10 and 20mg/day during 8 weeks in hypertriglyceridemic patients will reduce their triglyceride levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
334

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2007

Typical duration for phase_4

Geographic Reach
1 country

3 active sites

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

January 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 8, 2010

Completed
Last Updated

December 16, 2010

Status Verified

November 1, 2010

Enrollment Period

2.1 years

First QC Date

May 14, 2007

Results QC Date

May 10, 2010

Last Update Submit

November 30, 2010

Conditions

HypertriglyceridemiaHyperlipoproteinemia Type IVHyperlipoproteinemia Type VHyperlipoproteinemia Type IIbHyperlipidemia

Keywords

TriglycerideshypertriglyceridemiastatinsrosuvastatinhyperlipoproteinemiaFredrickson Type IIb or IV

Outcome Measures

Primary Outcomes (1)

  • Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8)

    Reduction from baseline to end of study

    8 weeks

Secondary Outcomes (8)

  • Non-HDL-C Reduction

    8 weeks

  • LDL-C Reduction

    8 weeks

  • Total Cholesterol Reduction

    8 weeks

  • HDL-C Increase

    8 weeks

  • ApoA1 Levels

    8 weeks

  • +3 more secondary outcomes

Interventions

rosuvastatinDRUG

10mg or 20mg

Eligibility Criteria

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

You may qualify if:

  • Patients older than 18 years, both genders, without any previous treatment with statins or other lipid lowering drugs for at least 6 months
  • With elevated triglycerides above 200 and below 800mg/dl and willing to follow all study procedures including assisting to clinics, fasting before blood samples and signing a written consent

You may not qualify if:

  • High levels of low-density lipoprotein cholesterol (LDL-C)
  • Unstable cardiovascular condition or awaiting a myocardial revascularization
  • Congestive cardiac failure
  • Uncontrolled diabetes
  • Cancer
  • Uncontrolled hypothyroidism
  • Familial hypercholesterolemia
  • Liver/muscle disease
  • Pregnancy
  • Other

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Guadalajara, Jalisco, Mexico

Location

Research Site

Mexico City, Mexico City, Mexico

Location

Research Site

Monterrey, Nuevo León, Mexico

Location

Related Publications (1)

  • Talavera JO, Martinez G, Cervantes JL, Marin JA, Rodriguez-Briones I, Gonzalez JG, Ocampo R, Sanchez-Mijangos H, Bernal-Rosales LP, Polanco A. A double-blind, double-dummy, randomized, placebo-controlled trial to evaluate the effect of statin therapy on triglyceride levels in Mexican hypertriglyceridemic patients. Curr Med Res Opin. 2013 Apr;29(4):379-86. doi: 10.1185/03007995.2013.766590. Epub 2013 Feb 21.

    PMID: 23323877DERIVED

MeSH Terms

Conditions

HypertriglyceridemiaHyperlipoproteinemia Type IVHyperlipoproteinemia Type VHyperlipoproteinemia Type IIHyperlipidemiasHyperlipoproteinemias

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com
09645895

Study Officials

  • Ana Polanco, MD

    AstraZeneca Mexico

    STUDY DIRECTOR

  • Ana Polanco, MD

    AstraZeneca Mexico

    STUDY CHAIR

  • Juan Talavera, MD

    IMSS

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 14, 2007

First Posted

May 15, 2007

Study Start

January 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

December 16, 2010

Results First Posted

June 8, 2010

Record last verified: 2010-11

Locations

ME(3)