Trial Outcomes & Findings for Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Type IIa and IIb Hypercholesterolaemic Patients (NCT NCT00631189)
NCT ID: NCT00631189
Last Updated: 2013-11-26
Results Overview
To compare the percentages of LDL-C level variation. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data
COMPLETED
PHASE4
668 participants
Change from baseline and after 8 weeks of treatment
2013-11-26
Participant Flow
Patients were recruited by general practitioner. First patient included: 12 October 2007 Last patient terminated the study: 04 October 2008
This French multicentre, randomized double-blind study was conducted on three parallel arms. The 14-week study comprised 3 visits: a screening visit (week 0, V1), a randomization and treatment allocation visit (week 6, V2) and an evaluation visit (week 14, V3). Patients were randomized at V2 and were treated for a period of 8 weeks.
Participant milestones
| Measure |
Initial Phase
Initial phase (between V1 and V2)
|
Atorvastatin
Atorvastatin 10 mg
|
Pravastatin
Pravastatin 40 mg
|
Rosuvastatin
Rosuvastatin 5 mg
|
|---|---|---|---|---|
|
Initial Phase
STARTED
|
668
|
0
|
0
|
0
|
|
Initial Phase
COMPLETED
|
317
|
0
|
0
|
0
|
|
Initial Phase
NOT COMPLETED
|
351
|
0
|
0
|
0
|
|
Treatment Phase
STARTED
|
0
|
104
|
103
|
110
|
|
Treatment Phase
COMPLETED
|
0
|
97
|
92
|
103
|
|
Treatment Phase
NOT COMPLETED
|
0
|
7
|
11
|
7
|
Reasons for withdrawal
| Measure |
Initial Phase
Initial phase (between V1 and V2)
|
Atorvastatin
Atorvastatin 10 mg
|
Pravastatin
Pravastatin 40 mg
|
Rosuvastatin
Rosuvastatin 5 mg
|
|---|---|---|---|---|
|
Initial Phase
Protocol Violation
|
347
|
0
|
0
|
0
|
|
Initial Phase
Withdrawal by Subject
|
4
|
0
|
0
|
0
|
|
Treatment Phase
Withdrawal by Subject
|
0
|
2
|
1
|
1
|
|
Treatment Phase
Protocol Violation
|
0
|
1
|
6
|
2
|
|
Treatment Phase
Adverse Event
|
0
|
3
|
2
|
4
|
|
Treatment Phase
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Treatment Phase
Pregnancy
|
0
|
0
|
1
|
0
|
|
Treatment Phase
patient did not take pravastatin
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Type IIa and IIb Hypercholesterolaemic Patients
Baseline characteristics by cohort
| Measure |
Initial Phase
Initial phase (between V1 and V2)
|
Atorvastatin
n=104 Participants
Atorvastatin 10 mg
|
Pravastatin
n=103 Participants
Pravastatin 40 mg
|
Rosuvastatin
n=110 Participants
Rosuvastatin 5 mg
|
Total
n=317 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
—
|
57.31 years
STANDARD_DEVIATION 10.59 • n=4 Participants
|
57.23 years
STANDARD_DEVIATION 10.8 • n=27 Participants
|
57.04 years
STANDARD_DEVIATION 9.32 • n=483 Participants
|
57.18 years
STANDARD_DEVIATION 9.95 • n=36 Participants
|
|
Gender
Female
|
—
|
49 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
46 Participants
n=483 Participants
|
150 Participants
n=36 Participants
|
|
Gender
Male
|
—
|
55 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
64 Participants
n=483 Participants
|
167 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Change from baseline and after 8 weeks of treatmentPopulation: 92 patients completed the study in the Pravastatin group, nevertheless, primary and secondary outcome measures are described on 91 patients in the Pravastatin arm due to one missing data in this group
To compare the percentages of LDL-C level variation. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data
Outcome measures
| Measure |
Initial Phase
Initial phase (between V1 and V2)
|
Atorvastatin
n=97 Participants
Atorvastatin 10 mg
|
Pravastatin
n=91 Participants
Pravastatin 40 mg
|
Rosuvastatin
n=103 Participants
Rosuvastatin 5 mg
|
|---|---|---|---|---|
|
Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks
|
—
|
-39.4 percentage of LDL-C decrease
Standard Deviation 13.77 • Interval -13.77 to 13.77
|
-30.3 percentage of LDL-C decrease
Standard Deviation 15.43 • Interval -15.43 to 15.43
|
-37.6 percentage of LDL-C decrease
Standard Deviation 17.96 • Interval -17.96 to 17.96
|
SECONDARY outcome
Timeframe: Not doneNot done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Not doneNot done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline and after 8 weeks of treatmentTo compare the percentage of total cholesterol variation taking baseline value as a reference. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data
Outcome measures
| Measure |
Initial Phase
Initial phase (between V1 and V2)
|
Atorvastatin
n=97 Participants
Atorvastatin 10 mg
|
Pravastatin
n=91 Participants
Pravastatin 40 mg
|
Rosuvastatin
n=103 Participants
Rosuvastatin 5 mg
|
|---|---|---|---|---|
|
Compare the Percentage of Total Cholesterol Variation From Baseline and After 8 Weeks of Treatment
|
—
|
-28.6 percentage of total cholesterol decrease
Standard Deviation 11.0
|
-20.4 percentage of total cholesterol decrease
Standard Deviation 11.7
|
-25.2 percentage of total cholesterol decrease
Standard Deviation 14.0
|
SECONDARY outcome
Timeframe: After 8 weeks of treatmentCompare the percentage of HDL-C (High Density Lipoprotein Cholesterol) variation taking baseline value as a reference and after 8 weeks of treatment. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data
Outcome measures
| Measure |
Initial Phase
Initial phase (between V1 and V2)
|
Atorvastatin
n=97 Participants
Atorvastatin 10 mg
|
Pravastatin
n=91 Participants
Pravastatin 40 mg
|
Rosuvastatin
n=103 Participants
Rosuvastatin 5 mg
|
|---|---|---|---|---|
|
Compare the Percentage of HDL-C (High Density Lipoprotein Cholesterol) Variation From Baseline and After 8 Weeks of Treatment
|
—
|
4.4 percentage of HDL-C increase
Standard Deviation 14.3
|
7.9 percentage of HDL-C increase
Standard Deviation 19.2
|
11.3 percentage of HDL-C increase
Standard Deviation 20.6
|
SECONDARY outcome
Timeframe: Baseline and after 8 weeks of treatmentTo compare the percentage of variation from baseline triglycerides values and after 8 weeks. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data
Outcome measures
| Measure |
Initial Phase
Initial phase (between V1 and V2)
|
Atorvastatin
n=97 Participants
Atorvastatin 10 mg
|
Pravastatin
n=91 Participants
Pravastatin 40 mg
|
Rosuvastatin
n=103 Participants
Rosuvastatin 5 mg
|
|---|---|---|---|---|
|
Compare the Percentage of Variation From Baseline Triglycerides Values and After 8 Weeks
|
—
|
-19.2 percentage of triglycerides decrease
Standard Deviation 25
|
-6.1 percentage of triglycerides decrease
Standard Deviation 31.6
|
-8.7 percentage of triglycerides decrease
Standard Deviation 37
|
SECONDARY outcome
Timeframe: baseline and after 8 weeks of treatmentTo Compare the percentage of variation from baseline Apolipoprotein B/Apolipoprotein A1 ratio and after 8 weeks of treatment. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data
Outcome measures
| Measure |
Initial Phase
Initial phase (between V1 and V2)
|
Atorvastatin
n=97 Participants
Atorvastatin 10 mg
|
Pravastatin
n=91 Participants
Pravastatin 40 mg
|
Rosuvastatin
n=103 Participants
Rosuvastatin 5 mg
|
|---|---|---|---|---|
|
Compare the Percentage of Variation From Baseline Apolipoprotein B/Apolipoprotein A1 Ratio and After 8 Weeks of Treatment
|
—
|
-30.9 percent. Apolipoprotein B/A1 decrease
Standard Deviation 14.7
|
-26 percent. Apolipoprotein B/A1 decrease
Standard Deviation 13.5
|
-31.9 percent. Apolipoprotein B/A1 decrease
Standard Deviation 17
|
SECONDARY outcome
Timeframe: baseline and after 8 weeks of treatmentTo compare the percentage of variation of C-reactive protein (CRP) taking baseline values as reference. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data
Outcome measures
| Measure |
Initial Phase
Initial phase (between V1 and V2)
|
Atorvastatin
n=97 Participants
Atorvastatin 10 mg
|
Pravastatin
n=91 Participants
Pravastatin 40 mg
|
Rosuvastatin
n=103 Participants
Rosuvastatin 5 mg
|
|---|---|---|---|---|
|
Compare the Percentage of Variation of C-reactive Protein (CRP)
|
—
|
37.3 percent of variation of C-reactive prot.
Standard Deviation 187.4
|
33.1 percent of variation of C-reactive prot.
Standard Deviation 184.2
|
15.2 percent of variation of C-reactive prot.
Standard Deviation 104.9
|
SECONDARY outcome
Timeframe: from baseline and after 8 weeks of treatmentTo Compare the percentage of variation of phospholipase A2 (PLA2) taking baseline value as a reference. As the recruitment target was not reached at the date initially planned, and view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data
Outcome measures
| Measure |
Initial Phase
Initial phase (between V1 and V2)
|
Atorvastatin
n=84 Participants
Atorvastatin 10 mg
|
Pravastatin
n=78 Participants
Pravastatin 40 mg
|
Rosuvastatin
n=83 Participants
Rosuvastatin 5 mg
|
|---|---|---|---|---|
|
Compare the Percentage of Variation of Phospholipase A2 (PLA2)
|
—
|
5.6 percent of variation of phospholipase A2
Standard Deviation 46.4
|
13 percent of variation of phospholipase A2
Standard Deviation 73.6
|
2.9 percent of variation of phospholipase A2
Standard Deviation 24.2
|
SECONDARY outcome
Timeframe: from baseline and after 8 weeks of treatmentTo Compare numbers of patients achieving the LDL-C goal according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP). As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data. The percentage of patients achieving the NCEP-ATP III LDL-C goal. ATP III is categorized into 3 risk categories:(1) established CHD and CHD risk equivalents(2) multiple risk factors(3) zero to one (0-1) risk factor
Outcome measures
| Measure |
Initial Phase
Initial phase (between V1 and V2)
|
Atorvastatin
n=97 Participants
Atorvastatin 10 mg
|
Pravastatin
n=91 Participants
Pravastatin 40 mg
|
Rosuvastatin
n=103 Participants
Rosuvastatin 5 mg
|
|---|---|---|---|---|
|
Compare the Numbers of Patients Achieving the LDL-C Goal According to the National Cholesterol Education Program Adult Treatment Panel III (NCEP) ATP III) Guidelines for the Management of Dyslipidaemic Patients
|
—
|
42 Participants
|
22 Participants
|
38 Participants
|
SECONDARY outcome
Not done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: duration of studySerious Adverse Event and Adverse Event reported throughout the study
Outcome measures
| Measure |
Initial Phase
n=317 Participants
Initial phase (between V1 and V2)
|
Atorvastatin
n=97 Participants
Atorvastatin 10 mg
|
Pravastatin
n=92 Participants
Pravastatin 40 mg
|
Rosuvastatin
n=103 Participants
Rosuvastatin 5 mg
|
|---|---|---|---|---|
|
To Evaluate Clinical and Laboratory Safety
|
8 Adverse Events
|
9 Adverse Events
|
8 Adverse Events
|
5 Adverse Events
|
Adverse Events
Initial Phase
Atorvastatin
Pravastatin
Rosuvastatin
Serious adverse events
| Measure |
Initial Phase
n=317 participants at risk
Initial phase (between V1 and V2)
|
Atorvastatin
n=97 participants at risk
Atorvastatin 10 mg
|
Pravastatin
n=92 participants at risk
Pravastatin 40 mg
|
Rosuvastatin
n=103 participants at risk
Rosuvastatin 5 mg
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Coxarthrosisaggravation
|
0.32%
1/317
|
0.00%
0/97
|
0.00%
0/92
|
0.00%
0/103
|
|
Reproductive system and breast disorders
Benign prostatic nodular hyperplasia
|
0.00%
0/317
|
0.00%
0/97
|
1.1%
1/92
|
0.00%
0/103
|
|
Nervous system disorders
Carotid thrombosis
|
0.32%
1/317
|
0.00%
0/97
|
0.00%
0/92
|
0.00%
0/103
|
|
Nervous system disorders
Left Lumbar Cruralgia
|
0.00%
0/317
|
1.0%
1/97
|
0.00%
0/92
|
0.00%
0/103
|
|
Gastrointestinal disorders
VIiolent abdominal pain
|
0.00%
0/317
|
1.0%
1/97
|
0.00%
0/92
|
0.00%
0/103
|
|
Musculoskeletal and connective tissue disorders
Worsening of gonalgia
|
0.00%
0/317
|
1.0%
1/97
|
0.00%
0/92
|
0.00%
0/103
|
|
Nervous system disorders
Morton syndrome
|
0.00%
0/317
|
1.0%
1/97
|
0.00%
0/92
|
0.00%
0/103
|
Other adverse events
| Measure |
Initial Phase
n=317 participants at risk
Initial phase (between V1 and V2)
|
Atorvastatin
n=97 participants at risk
Atorvastatin 10 mg
|
Pravastatin
n=92 participants at risk
Pravastatin 40 mg
|
Rosuvastatin
n=103 participants at risk
Rosuvastatin 5 mg
|
|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/317
|
0.00%
0/97
|
0.00%
0/92
|
0.97%
1/103
|
|
Gastrointestinal disorders
gingival hypoplasia
|
0.00%
0/317
|
1.0%
1/97
|
0.00%
0/92
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
skin discolouration
|
0.00%
0/317
|
0.00%
0/97
|
1.1%
1/92
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
erythema
|
0.00%
0/317
|
0.00%
0/97
|
0.00%
0/92
|
0.97%
1/103
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/317
|
0.00%
0/97
|
0.00%
0/92
|
0.97%
1/103
|
|
Reproductive system and breast disorders
benign prostatic hyperplasia
|
0.00%
0/317
|
0.00%
0/97
|
1.1%
1/92
|
0.00%
0/103
|
|
Immune system disorders
hypersensitivity
|
0.32%
1/317
|
0.00%
0/97
|
0.00%
0/92
|
0.00%
0/103
|
|
Nervous system disorders
Headache
|
0.32%
1/317
|
0.00%
0/97
|
0.00%
0/92
|
0.00%
0/103
|
|
Nervous system disorders
Morton's neuralgia
|
0.32%
1/317
|
0.00%
0/97
|
0.00%
0/92
|
0.00%
0/103
|
|
Nervous system disorders
Sciatica
|
0.32%
1/317
|
0.00%
0/97
|
0.00%
0/92
|
0.00%
0/103
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/317
|
0.00%
0/97
|
0.00%
0/92
|
0.97%
1/103
|
|
Gastrointestinal disorders
abdominal distension
|
0.00%
0/317
|
0.00%
0/97
|
1.1%
1/92
|
0.00%
0/103
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/317
|
1.0%
1/97
|
0.00%
0/92
|
0.00%
0/103
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/317
|
0.00%
0/97
|
2.2%
2/92
|
0.00%
0/103
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/317
|
0.00%
0/97
|
3.3%
3/92
|
0.00%
0/103
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/317
|
0.00%
0/97
|
2.2%
2/92
|
0.00%
0/103
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/317
|
1.0%
1/97
|
1.1%
1/92
|
0.00%
0/103
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/317
|
0.00%
0/97
|
1.1%
1/92
|
1.9%
2/103
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.32%
1/317
|
0.00%
0/97
|
1.1%
1/92
|
0.00%
0/103
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/317
|
1.0%
1/97
|
0.00%
0/92
|
1.9%
2/103
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/317
|
0.00%
0/97
|
1.1%
1/92
|
0.00%
0/103
|
|
Eye disorders
visual impairment
|
0.00%
0/317
|
0.00%
0/97
|
0.00%
0/92
|
0.97%
1/103
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis
|
0.32%
1/317
|
0.00%
0/97
|
0.00%
0/92
|
0.00%
0/103
|
|
Vascular disorders
venous insufficiency
|
0.00%
0/317
|
1.0%
1/97
|
0.00%
0/92
|
0.00%
0/103
|
|
Vascular disorders
deep vein thrombosis
|
0.00%
0/317
|
1.0%
1/97
|
0.00%
0/92
|
0.00%
0/103
|
|
Musculoskeletal and connective tissue disorders
knee arthroplasty joint prosthesis user
|
0.32%
1/317
|
0.00%
0/97
|
0.00%
0/92
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Ear Infection
|
0.32%
1/317
|
0.00%
0/97
|
0.00%
0/92
|
0.00%
0/103
|
|
Infections and infestations
fungal infection
|
0.00%
0/317
|
0.00%
0/97
|
1.1%
1/92
|
0.00%
0/103
|
|
Infections and infestations
lung infection
|
0.00%
0/317
|
0.00%
0/97
|
1.1%
1/92
|
0.00%
0/103
|
|
Infections and infestations
vaginal infection
|
0.00%
0/317
|
0.00%
0/97
|
0.00%
0/92
|
0.97%
1/103
|
|
Infections and infestations
Laryngitis
|
0.32%
1/317
|
0.00%
0/97
|
0.00%
0/92
|
0.00%
0/103
|
|
Infections and infestations
Otitis externa
|
0.32%
1/317
|
0.00%
0/97
|
0.00%
0/92
|
0.00%
0/103
|
|
Infections and infestations
Rhinitis
|
0.32%
1/317
|
0.00%
0/97
|
0.00%
0/92
|
0.00%
0/103
|
|
Infections and infestations
sinusitis
|
0.32%
1/317
|
0.00%
0/97
|
0.00%
0/92
|
0.00%
0/103
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.32%
1/317
|
0.00%
0/97
|
0.00%
0/92
|
0.00%
0/103
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/317
|
1.0%
1/97
|
0.00%
0/92
|
0.00%
0/103
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If the PI wants to discuss or publish results after the trial is completed he must obtain writing authorization from AstraZeneca
- Publication restrictions are in place
Restriction type: OTHER