Effect of Rosuvastatin on Triglyceride Levels in Mexican Hypertriglyceridemic Patients

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AstraZeneca

Status and phase

Completed
Phase 4

Conditions

Hyperlipoproteinemia Type IIb
Hyperlipidemia
Hypertriglyceridemia
Hyperlipoproteinemia Type V
Hyperlipoproteinemia Type IV

Treatments

Drug: rosuvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00473655
DM-CRESTOR-0002

Details and patient eligibility

About

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.

Enrollment

334 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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