Trial Outcomes & Findings for Effect of Rosuvastatin on Triglyceride Levels in Mexican Hypertriglyceridemic Patients (NCT NCT00473655)
NCT ID: NCT00473655
Last Updated: 2010-12-16
Results Overview
Reduction from baseline to end of study
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
334 participants
Primary outcome timeframe
8 weeks
Results posted on
2010-12-16
Participant Flow
All participants where outpatients recruited from clinical centers. Recruitment began on August 2007 and ends on October 2008
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.
Participant milestones
| Measure |
Rosuvastatin 10 mg
Rosuvastatin 10 mg
|
Rosuvastatin 20 mg
Rosuvastatin 20 mg
|
Placebo
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
111
|
112
|
111
|
|
Overall Study
COMPLETED
|
102
|
107
|
103
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
8
|
Reasons for withdrawal
| Measure |
Rosuvastatin 10 mg
Rosuvastatin 10 mg
|
Rosuvastatin 20 mg
Rosuvastatin 20 mg
|
Placebo
Placebo
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
5
|
8
|
Baseline Characteristics
Effect of Rosuvastatin on Triglyceride Levels in Mexican Hypertriglyceridemic Patients
Baseline characteristics by cohort
| Measure |
Rosuvastatin 10 mg
n=111 Participants
Rosuvastatin 10 mg
|
Rosuvastatin 20 mg
n=112 Participants
Rosuvastatin 20 mg
|
Placebo
n=111 Participants
Placebo
|
Total
n=334 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
Age
|
52.57 Years
STANDARD_DEVIATION 12.77 • n=5 Participants
|
53.14 Years
STANDARD_DEVIATION 12 • n=7 Participants
|
51.48 Years
STANDARD_DEVIATION 13.47 • n=5 Participants
|
52.4 Years
STANDARD_DEVIATION 12.74 • n=4 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
173 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
|
Arterial Hypertension
Arterial Hypertension
|
36 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Diabetes mellitus
Diabetes mellitus
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Body mass index continuous
Body mass index
|
30.72 Kg/m2
STANDARD_DEVIATION 5.11 • n=5 Participants
|
29.77 Kg/m2
STANDARD_DEVIATION 4.04 • n=7 Participants
|
30.36 Kg/m2
STANDARD_DEVIATION 4.90 • n=5 Participants
|
30.28 Kg/m2
STANDARD_DEVIATION 4.71 • n=4 Participants
|
|
HDL-C levels, continuous
HDL-C
|
33.50 mg/dL
STANDARD_DEVIATION 7.52 • n=5 Participants
|
34.05 mg/dL
STANDARD_DEVIATION 6.88 • n=7 Participants
|
32.30 mg/dL
STANDARD_DEVIATION 6.49 • n=5 Participants
|
33.28 mg/dL
STANDARD_DEVIATION 6.99 • n=4 Participants
|
|
LDL-C, continuous
LDL-C
|
129.24 mg/dL
STANDARD_DEVIATION 28.23 • n=5 Participants
|
130.51 mg/dL
STANDARD_DEVIATION 29.19 • n=7 Participants
|
129.77 mg/dL
STANDARD_DEVIATION 31.10 • n=5 Participants
|
129.84 mg/dL
STANDARD_DEVIATION 29.45 • n=4 Participants
|
|
TG levels, continuous
Tg levels
|
319.51 mg/dL
STANDARD_DEVIATION 131.95 • n=5 Participants
|
296.78 mg/dL
STANDARD_DEVIATION 95.19 • n=7 Participants
|
309.46 mg/dL
STANDARD_DEVIATION 99.55 • n=5 Participants
|
308.25 mg/dL
STANDARD_DEVIATION 110.22 • n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeksReduction from baseline to end of study
Outcome measures
| Measure |
Rosuvastatin 10 mg
n=101 Participants
Rosuvastatin 10 mg
|
Rosuvastatin 20 mg
n=107 Participants
Rosuvastatin 20 mg
|
Placebo
n=103 Participants
Placebo
|
|---|---|---|---|
|
Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8)
|
67.95 mg/dL
Standard Deviation 128.46
|
78.61 mg/dL
Standard Deviation 121.51
|
22.31 mg/dL
Standard Deviation 120.54
|
SECONDARY outcome
Timeframe: 8 weeksReduction from baseline to end of study
Outcome measures
| Measure |
Rosuvastatin 10 mg
n=101 Participants
Rosuvastatin 10 mg
|
Rosuvastatin 20 mg
n=106 Participants
Rosuvastatin 20 mg
|
Placebo
n=102 Participants
Placebo
|
|---|---|---|---|
|
Non-HDL-C Reduction
|
52.76 mg/dL
Standard Deviation 48.08
|
61.31 mg/dL
Standard Deviation 46.63
|
1.06 mg/dL
Standard Deviation 37.41
|
SECONDARY outcome
Timeframe: 8 weeksReduction from baseline to end of study
Outcome measures
| Measure |
Rosuvastatin 10 mg
n=102 Participants
Rosuvastatin 10 mg
|
Rosuvastatin 20 mg
n=107 Participants
Rosuvastatin 20 mg
|
Placebo
n=102 Participants
Placebo
|
|---|---|---|---|
|
LDL-C Reduction
|
42.23 mg/dL
Standard Deviation 28.58
|
53.22 mg/dL
Standard Deviation 32.80
|
-2.66 mg/dL
Standard Deviation 28.78
|
SECONDARY outcome
Timeframe: 8 weeksReduction from baseline to end of study
Outcome measures
| Measure |
Rosuvastatin 10 mg
n=102 Participants
Rosuvastatin 10 mg
|
Rosuvastatin 20 mg
n=107 Participants
Rosuvastatin 20 mg
|
Placebo
n=103 Participants
Placebo
|
|---|---|---|---|
|
Total Cholesterol Reduction
|
49.73 mg/dL
Standard Deviation 41.13
|
63.32 mg/dL
Standard Deviation 42.97
|
-1.44 mg/dL
Standard Deviation 34.98
|
SECONDARY outcome
Timeframe: 8 weeksIncrease from baseline to end of study
Outcome measures
| Measure |
Rosuvastatin 10 mg
n=101 Participants
Rosuvastatin 10 mg
|
Rosuvastatin 20 mg
n=104 Participants
Rosuvastatin 20 mg
|
Placebo
n=102 Participants
Placebo
|
|---|---|---|---|
|
HDL-C Increase
|
3.49 mg/dL
Standard Deviation 7.16
|
2.49 mg/dL
Standard Deviation 5.78
|
1.95 mg/dL
Standard Deviation 7.42
|
SECONDARY outcome
Timeframe: 8 weeksChange in the levels from baseline to end of study
Outcome measures
| Measure |
Rosuvastatin 10 mg
n=101 Participants
Rosuvastatin 10 mg
|
Rosuvastatin 20 mg
n=106 Participants
Rosuvastatin 20 mg
|
Placebo
n=102 Participants
Placebo
|
|---|---|---|---|
|
ApoA1 Levels
|
4.66 mg/dl
Standard Deviation 23.38
|
6.79 mg/dl
Standard Deviation 18.60
|
2.65 mg/dl
Standard Deviation 19.40
|
SECONDARY outcome
Timeframe: 8 weeksReduction from baseline to end of study
Outcome measures
| Measure |
Rosuvastatin 10 mg
n=102 Participants
Rosuvastatin 10 mg
|
Rosuvastatin 20 mg
n=107 Participants
Rosuvastatin 20 mg
|
Placebo
n=103 Participants
Placebo
|
|---|---|---|---|
|
hsCRP Reduction
|
0.19 mg/L
Standard Deviation 1.16
|
0.11 mg/L
Standard Deviation 0.35
|
-0.01 mg/L
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: 8 weeksNumber of participants with AEs and SAEs reported
Outcome measures
| Measure |
Rosuvastatin 10 mg
n=111 Participants
Rosuvastatin 10 mg
|
Rosuvastatin 20 mg
n=112 Participants
Rosuvastatin 20 mg
|
Placebo
n=111 Participants
Placebo
|
|---|---|---|---|
|
Adverse Events Reported
|
27 Participants
|
29 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 8 weeksChange in the levels from baseline to end of study
Outcome measures
| Measure |
Rosuvastatin 10 mg
n=101 Participants
Rosuvastatin 10 mg
|
Rosuvastatin 20 mg
n=106 Participants
Rosuvastatin 20 mg
|
Placebo
n=102 Participants
Placebo
|
|---|---|---|---|
|
ApoB Levels
|
-27.05 mg/dl
Standard Deviation 26.92
|
-36.81 mg/dl
Standard Deviation 23.51
|
1.43 mg/dl
Standard Deviation 26.03
|
Adverse Events
Rosuvastatin 10 mg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Rosuvastatin 20 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rosuvastatin 10 mg
n=111 participants at risk
Rosuvastatin 10 mg
|
Rosuvastatin 20 mg
n=112 participants at risk
Rosuvastatin 20 mg
|
Placebo
n=111 participants at risk
Placebo
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Femur And Rotula Right Fracture That Required Hospitalization
|
0.90%
1/111
|
0.00%
0/112
|
0.00%
0/111
|
Other adverse events
| Measure |
Rosuvastatin 10 mg
n=111 participants at risk
Rosuvastatin 10 mg
|
Rosuvastatin 20 mg
n=112 participants at risk
Rosuvastatin 20 mg
|
Placebo
n=111 participants at risk
Placebo
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
2.7%
3/111
|
4.5%
5/112
|
4.5%
5/111
|
|
Renal and urinary disorders
Urinary tract infection
|
0.90%
1/111
|
0.89%
1/112
|
2.7%
3/111
|
|
Nervous system disorders
Cephalea
|
0.90%
1/111
|
2.7%
3/112
|
0.90%
1/111
|
|
Nervous system disorders
Dizziness
|
0.90%
1/111
|
1.8%
2/112
|
0.90%
1/111
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.90%
1/111
|
1.8%
2/112
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngotonsillitis
|
1.8%
2/111
|
0.89%
1/112
|
0.00%
0/111
|
|
Renal and urinary disorders
Leg Edema
|
0.00%
0/111
|
0.00%
0/112
|
1.8%
2/111
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER