Clinical trial NCT00473655: Effect of Rosuvastatin on Triglyceride Levels in Mexican Hypertriglyceridemic Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertriglyceridemia
Hyperlipoproteinemia Type IV
Hyperlipoproteinemia Type V
Hyperlipoproteinemia Type IIb
Hyperlipidemia
Keywords: Triglycerides
hypertriglyceridemia
statins
rosuvastatin
hyperlipoproteinemia
Fredrickson Type IIb or IV
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-05-15
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8)
timeFrame: 8 weeks
Secondary outcomes:
measure: Non-HDL-C Reduction
timeFrame: 8 weeks
measure: LDL-C Reduction
timeFrame: 8 weeks
measure: Total Cholesterol Reduction
timeFrame: 8 weeks
measure: HDL-C Increase
timeFrame: 8 weeks
measure: ApoA1 Levels
timeFrame: 8 weeks
measure: hsCRP Reduction
timeFrame: 8 weeks
measure: Adverse Events Reported
timeFrame: 8 weeks
measure: ApoB Levels
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Research Site
state: DF
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Research Site
state: Nuevo Leon
Study officials:
affiliation: AstraZeneca Mexico
name: Ana Polanco, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca Mexico
name: Ana Polanco, MD
role: STUDY_CHAIR
affiliation: IMSS
name: Juan Talavera, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.