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Effect of Rosuvastatin on Triglyceride Levels in Mexican Hypertriglyceridemic Patients

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00473655
Enrollment
334
Registered
2007-05-15
Start date
2007-01-31
Completion date
2009-02-28
Last updated
2010-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia, Hyperlipoproteinemia Type IIb, Hyperlipoproteinemia Type IV, Hyperlipoproteinemia Type V, Hypertriglyceridemia

Keywords

Triglycerides, hypertriglyceridemia, statins, rosuvastatin, hyperlipoproteinemia, Fredrickson Type IIb or IV

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.

Interventions

DRUGrosuvastatin

10mg or 20mg

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8)8 weeksReduction from baseline to end of study

Secondary

MeasureTime frameDescription
LDL-C Reduction8 weeksReduction from baseline to end of study
Total Cholesterol Reduction8 weeksReduction from baseline to end of study
HDL-C Increase8 weeksIncrease from baseline to end of study
Non-HDL-C Reduction8 weeksReduction from baseline to end of study
hsCRP Reduction8 weeksReduction from baseline to end of study
Adverse Events Reported8 weeksNumber of participants with AEs and SAEs reported
ApoB Levels8 weeksChange in the levels from baseline to end of study
ApoA1 Levels8 weeksChange in the levels from baseline to end of study

Countries

Mexico

Participant flow

Recruitment details

All participants where outpatients recruited from clinical centers. Recruitment began on August 2007 and ends on October 2008

Pre-assignment details

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.

Participants by arm

ArmCount
Rosuvastatin 10 mg
Rosuvastatin 10 mg
111
Rosuvastatin 20 mg
Rosuvastatin 20 mg
112
Placebo
Placebo
111
Total334

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up958

Baseline characteristics

CharacteristicRosuvastatin 10 mgRosuvastatin 20 mgPlaceboTotal
Age Continuous
Age
52.57 Years
STANDARD_DEVIATION 12.77
53.14 Years
STANDARD_DEVIATION 12
51.48 Years
STANDARD_DEVIATION 13.47
52.4 Years
STANDARD_DEVIATION 12.74
Arterial Hypertension
Arterial Hypertension
36 Participants35 Participants34 Participants105 Participants
Body mass index continuous
Body mass index
30.72 Kg/m2
STANDARD_DEVIATION 5.11
29.77 Kg/m2
STANDARD_DEVIATION 4.04
30.36 Kg/m2
STANDARD_DEVIATION 4.9
30.28 Kg/m2
STANDARD_DEVIATION 4.71
Diabetes mellitus
Diabetes mellitus
12 Participants16 Participants13 Participants41 Participants
HDL-C levels, continuous
HDL-C
33.50 mg/dL
STANDARD_DEVIATION 7.52
34.05 mg/dL
STANDARD_DEVIATION 6.88
32.30 mg/dL
STANDARD_DEVIATION 6.49
33.28 mg/dL
STANDARD_DEVIATION 6.99
LDL-C, continuous
LDL-C
129.24 mg/dL
STANDARD_DEVIATION 28.23
130.51 mg/dL
STANDARD_DEVIATION 29.19
129.77 mg/dL
STANDARD_DEVIATION 31.1
129.84 mg/dL
STANDARD_DEVIATION 29.45
Sex: Female, Male
Female
52 Participants67 Participants54 Participants173 Participants
Sex: Female, Male
Male
59 Participants45 Participants57 Participants161 Participants
TG levels, continuous
Tg levels
319.51 mg/dL
STANDARD_DEVIATION 131.95
296.78 mg/dL
STANDARD_DEVIATION 95.19
309.46 mg/dL
STANDARD_DEVIATION 99.55
308.25 mg/dL
STANDARD_DEVIATION 110.22

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
9 / 11112 / 11212 / 111
serious
Total, serious adverse events
1 / 1110 / 1120 / 111

Outcome results

Primary

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

Reduction from baseline to end of study

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
Rosuvastatin 10 mgChange (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8)67.95 mg/dLStandard Deviation 128.46
Rosuvastatin 20 mgChange (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8)78.61 mg/dLStandard Deviation 121.51
PlaceboChange (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8)22.31 mg/dLStandard Deviation 120.54
Secondary

Adverse Events Reported

Number of participants with AEs and SAEs reported

Time frame: 8 weeks

ArmMeasureValue (NUMBER)
Rosuvastatin 10 mgAdverse Events Reported27 Participants
Rosuvastatin 20 mgAdverse Events Reported29 Participants
PlaceboAdverse Events Reported20 Participants
Secondary

ApoA1 Levels

Change in the levels from baseline to end of study

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
Rosuvastatin 10 mgApoA1 Levels4.66 mg/dlStandard Deviation 23.38
Rosuvastatin 20 mgApoA1 Levels6.79 mg/dlStandard Deviation 18.6
PlaceboApoA1 Levels2.65 mg/dlStandard Deviation 19.4
Secondary

ApoB Levels

Change in the levels from baseline to end of study

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
Rosuvastatin 10 mgApoB Levels-27.05 mg/dlStandard Deviation 26.92
Rosuvastatin 20 mgApoB Levels-36.81 mg/dlStandard Deviation 23.51
PlaceboApoB Levels1.43 mg/dlStandard Deviation 26.03
Secondary

HDL-C Increase

Increase from baseline to end of study

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
Rosuvastatin 10 mgHDL-C Increase3.49 mg/dLStandard Deviation 7.16
Rosuvastatin 20 mgHDL-C Increase2.49 mg/dLStandard Deviation 5.78
PlaceboHDL-C Increase1.95 mg/dLStandard Deviation 7.42
Secondary

hsCRP Reduction

Reduction from baseline to end of study

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
Rosuvastatin 10 mghsCRP Reduction0.19 mg/LStandard Deviation 1.16
Rosuvastatin 20 mghsCRP Reduction0.11 mg/LStandard Deviation 0.35
PlacebohsCRP Reduction-0.01 mg/LStandard Deviation 1
Secondary

LDL-C Reduction

Reduction from baseline to end of study

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
Rosuvastatin 10 mgLDL-C Reduction42.23 mg/dLStandard Deviation 28.58
Rosuvastatin 20 mgLDL-C Reduction53.22 mg/dLStandard Deviation 32.8
PlaceboLDL-C Reduction-2.66 mg/dLStandard Deviation 28.78
Secondary

Non-HDL-C Reduction

Reduction from baseline to end of study

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
Rosuvastatin 10 mgNon-HDL-C Reduction52.76 mg/dLStandard Deviation 48.08
Rosuvastatin 20 mgNon-HDL-C Reduction61.31 mg/dLStandard Deviation 46.63
PlaceboNon-HDL-C Reduction1.06 mg/dLStandard Deviation 37.41
Secondary

Total Cholesterol Reduction

Reduction from baseline to end of study

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
Rosuvastatin 10 mgTotal Cholesterol Reduction49.73 mg/dLStandard Deviation 41.13
Rosuvastatin 20 mgTotal Cholesterol Reduction63.32 mg/dLStandard Deviation 42.97
PlaceboTotal Cholesterol Reduction-1.44 mg/dLStandard Deviation 34.98

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026