Back to resultsEffect of Rosuvastatin on Triglyceride Levels in Mexican Hypertriglyceridemic Patients
Primary Purpose
Hypertriglyceridemia, Hyperlipoproteinemia Type IV, Hyperlipoproteinemia Type V
Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
rosuvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Hypertriglyceridemia focused on measuring Triglycerides, hypertriglyceridemia, statins, rosuvastatin, hyperlipoproteinemia, Fredrickson Type IIb or IV
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
Sites / Locations
- Research Site
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8)
Reduction from baseline to end of study
Secondary Outcome Measures
Non-HDL-C Reduction
Reduction from baseline to end of study
LDL-C Reduction
Reduction from baseline to end of study
Total Cholesterol Reduction
Reduction from baseline to end of study
HDL-C Increase
Increase from baseline to end of study
ApoA1 Levels
Change in the levels from baseline to end of study
hsCRP Reduction
Reduction from baseline to end of study
Adverse Events Reported
Number of participants with AEs and SAEs reported
ApoB Levels
Change in the levels from baseline to end of study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00473655
Brief Title
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
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia, Hyperlipoproteinemia Type IV, Hyperlipoproteinemia Type V, Hyperlipoproteinemia Type IIb, Hyperlipidemia
Keywords
Triglycerides, hypertriglyceridemia, statins, rosuvastatin, hyperlipoproteinemia, Fredrickson Type IIb or IV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
334 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
rosuvastatin
Intervention Description
10mg or 20mg
Primary Outcome Measure Information:
Title
Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8)
Description
Reduction from baseline to end of study
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Non-HDL-C Reduction
Description
Reduction from baseline to end of study
Time Frame
8 weeks
Title
LDL-C Reduction
Description
Reduction from baseline to end of study
Time Frame
8 weeks
Title
Total Cholesterol Reduction
Description
Reduction from baseline to end of study
Time Frame
8 weeks
Title
HDL-C Increase
Description
Increase from baseline to end of study
Time Frame
8 weeks
Title
ApoA1 Levels
Description
Change in the levels from baseline to end of study
Time Frame
8 weeks
Title
hsCRP Reduction
Description
Reduction from baseline to end of study
Time Frame
8 weeks
Title
Adverse Events Reported
Description
Number of participants with AEs and SAEs reported
Time Frame
8 weeks
Title
ApoB Levels
Description
Change in the levels from baseline to end of study
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Polanco, MD
Organizational Affiliation
AstraZeneca Mexico
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ana Polanco, MD
Organizational Affiliation
AstraZeneca Mexico
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Juan Talavera, MD
Organizational Affiliation
IMSS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Mexico City
State/Province
DF
Country
Mexico
Facility Name
Research Site
City
Guadalajara
State/Province
Jalisco
Country
Mexico
Facility Name
Research Site
City
Monterrey
State/Province
Nuevo Leon
Country
Mexico
12. IPD Sharing Statement
Citations:
PubMed Identifier
23323877
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.
Results Reference
derived
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Effect of Rosuvastatin on Triglyceride Levels in Mexican Hypertriglyceridemic Patients
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