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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rosuvastatin | Drug | 10mg or 20mg |
| Measure | Description | Time Frame |
|---|---|---|
| Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8) | Reduction from baseline to end of study | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Non-HDL-C Reduction | Reduction from baseline to end of study | 8 weeks |
| LDL-C Reduction | Reduction from baseline to end of study | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana Polanco, MD | AstraZeneca Mexico | Study Director |
| Ana Polanco, MD | AstraZeneca Mexico | Study Chair |
| Juan Talavera, MD | IMSS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Guadalajara | Jalisco | Mexico | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23323877 | Derived | 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. |
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Participants with informed consent signed, and all inclusion criteria with no exclusion criteria, entered the lead in period, where they received a low fat diet. After 4 weeks if they still had TGs above 200 mg/dl they entered the randomization phase.
All participants where outpatients recruited from clinical centers. Recruitment began on August 2007 and ends on October 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Rosuvastatin 10 mg | Rosuvastatin 10 mg |
| FG001 | Rosuvastatin 20 mg | Rosuvastatin 20 mg |
| FG002 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rosuvastatin 10 mg | Rosuvastatin 10 mg |
| BG001 | Rosuvastatin 20 mg | Rosuvastatin 20 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8) | Reduction from baseline to end of study | Posted | Mean | Standard Deviation | mg/dL | 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rosuvastatin 10 mg | Rosuvastatin 10 mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femur And Rotula Right Fracture That Required Hospitalization | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | 09645895 | 44 15 | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| D006953 | Hyperlipoproteinemia Type IV |
| D006954 | Hyperlipoproteinemia Type V |
| D006938 | Hyperlipoproteinemia Type II |
| D006949 | Hyperlipidemias |
| D006951 | Hyperlipoproteinemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Total Cholesterol Reduction | Reduction from baseline to end of study | 8 weeks |
| HDL-C Increase | Increase from baseline to end of study | 8 weeks |
| ApoA1 Levels | Change in the levels from baseline to end of study | 8 weeks |
| hsCRP Reduction | Reduction from baseline to end of study | 8 weeks |
| Adverse Events Reported | Number of participants with AEs and SAEs reported | 8 weeks |
| ApoB Levels | Change in the levels from baseline to end of study | 8 weeks |
| Mexico City |
| Mexico City |
| Mexico |
| Research Site | Monterrey | Nuevo León | Mexico |
| BG002 |
| Placebo |
Placebo |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Arterial Hypertension | Number | Participants |
|
| Diabetes mellitus | Number | Participants |
|
| Body mass index continuous | Mean | Standard Deviation | Kg/m2 |
|
| HDL-C levels, continuous | Mean | Standard Deviation | mg/dL |
|
| LDL-C, continuous | Mean | Standard Deviation | mg/dL |
|
| TG levels, continuous | Mean | Standard Deviation | mg/dL |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Non-HDL-C Reduction | Reduction from baseline to end of study | Posted | Mean | Standard Deviation | mg/dL | 8 weeks |
|
|
|
| Secondary | LDL-C Reduction | Reduction from baseline to end of study | Posted | Mean | Standard Deviation | mg/dL | 8 weeks |
|
|
|
| Secondary | Total Cholesterol Reduction | Reduction from baseline to end of study | Posted | Mean | Standard Deviation | mg/dL | 8 weeks |
|
|
|
| Secondary | HDL-C Increase | Increase from baseline to end of study | Posted | Mean | Standard Deviation | mg/dL | 8 weeks |
|
|
|
| Secondary | ApoA1 Levels | Change in the levels from baseline to end of study | Posted | Mean | Standard Deviation | mg/dl | 8 weeks |
|
|
|
| Secondary | hsCRP Reduction | Reduction from baseline to end of study | Posted | Mean | Standard Deviation | mg/L | 8 weeks |
|
|
|
| Secondary | Adverse Events Reported | Number of participants with AEs and SAEs reported | Posted | Number | Participants | 8 weeks |
|
|
|
| Secondary | ApoB Levels | Change in the levels from baseline to end of study | Posted | Mean | Standard Deviation | mg/dl | 8 weeks |
|
|
|
| 1 |
| 111 |
| 9 |
| 111 |
| EG001 | Rosuvastatin 20 mg | Rosuvastatin 20 mg | 0 | 112 | 12 | 112 |
| EG002 | Placebo | Placebo | 0 | 111 | 12 | 111 |
| Urinary tract infection | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cephalea | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pharyngotonsillitis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Leg Edema | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
PI has the right to publish Study results in scientific journals. PI may use the Study results but not publish any results until: the date of the first Study results publication or the end of the 18-month period following the completion of the Study. PI shall provide AZ with the material for review. AZ has the right to publish the Study results
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |