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Effect of Rosuvastatin on Triglyceride Levels in Mexican Hypertriglyceridemic Patients

NCT ID: NCT00473655

Last Updated: 2010-12-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

334 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertriglyceridemia Hyperlipoproteinemia Type IV Hyperlipoproteinemia Type V Hyperlipoproteinemia Type IIb Hyperlipidemia

Keywords

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Triglycerides hypertriglyceridemia statins rosuvastatin hyperlipoproteinemia Fredrickson Type IIb or IV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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rosuvastatin

10mg or 20mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Ana Polanco, MD

Role: STUDY_DIRECTOR

AstraZeneca Mexico

Ana Polanco, MD

Role: STUDY_CHAIR

AstraZeneca Mexico

Juan Talavera, MD

Role: PRINCIPAL_INVESTIGATOR

IMSS

Locations

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Research Site

Guadalajara, Jalisco, Mexico

Site Status

Research Site

Mexico City, Mexico City, Mexico

Site Status

Research Site

Monterrey, Nuevo León, Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type DERIVED
PMID: 23323877 (View on PubMed)

Other Identifiers

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DM-CRESTOR-0002

Identifier Type: -

Identifier Source: org_study_id