Phase 4
N=334
Effect of Rosuvastatin on Triglyceride Levels in Mexican Hypertriglyceridemic Patients
Hypertriglyceridemia · Hyperlipoproteinemia Type IV · Hyperlipoproteinemia Type V · Hyperlipoproteinemia Type IIb · Hyperlipidemia
Bottom Line
View on ClinicalTrials.gov: NCT00473655 ↗Enrolled (actual)
334
Serious AEs
0.3%
Results posted
Jun 2010
Primary outcome: Primary: Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8) — 67.95; 78.61; 22.31 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- rosuvastatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8) |
67.95; 78.61; 22.31 | — |
| SECONDARY Non-HDL-C Reduction |
52.76; 61.31; 1.06 | — |
| SECONDARY LDL-C Reduction |
42.23; 53.22; -2.66 | — |
| SECONDARY Total Cholesterol Reduction |
49.73; 63.32; -1.44 | — |
| SECONDARY HDL-C Increase |
3.49; 2.49; 1.95 | — |
| SECONDARY ApoA1 Levels |
4.66; 6.79; 2.65 | — |
| SECONDARY hsCRP Reduction |
0.19; 0.11; -0.01 | — |
| SECONDARY Adverse Events Reported |
27; 29; 20 | — |
| SECONDARY ApoB Levels |
-27.05; -36.81; 1.43 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00473655). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.