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OpenTrials
Completed

NCT Number: NCT00473655

Effect of Rosuvastatin on Triglyceride Levels in Mexican Hypertriglyceridemic Patients

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.

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Key information

Conditions

Hypertriglyceridemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemia Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemia Type IIb Hyperlipoproteinemia Type IV Hyperlipoproteinemia Type V Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Guadalajara, Jalisco, Mexico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

10mg or 20mg

Primary outcomes

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

    Time frame: 8 weeks

    Reduction from baseline to end of study

Secondary outcomes

  1. Non-HDL-C Reduction

    Time frame: 8 weeks

    Reduction from baseline to end of study

  2. LDL-C Reduction

    Time frame: 8 weeks

    Reduction from baseline to end of study

  3. Total Cholesterol Reduction

    Time frame: 8 weeks

    Reduction from baseline to end of study

  4. HDL-C Increase

    Time frame: 8 weeks

    Increase from baseline to end of study

  5. ApoA1 Levels

    Time frame: 8 weeks

    Change in the levels from baseline to end of study

  6. hsCRP Reduction

    Time frame: 8 weeks

    Reduction from baseline to end of study

  7. Adverse Events Reported

    Time frame: 8 weeks

    Number of participants with AEs and SAEs reported

  8. ApoB Levels

    Time frame: 8 weeks

    Change in the levels from baseline to end of study

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Double-blind, Double Dummy, Phase IV, Randomized, Multicenter, Parallel Group, Placebo Controlled Trial to Evaluate the Effect of Rosuvastatin on Triglycerides Levels in Mexican Hypertriglyceridemic Patients

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 15, 2007
Registry last updated
Dec 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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