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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

This trial is to compare the efficacy, safety and tolerability of Rosuvastatin  with Atorvastatin by assessing the change of LDL-C in patients with hypercholesterolemia and history of coronary heart disease (CHD) or risk equivalent, or a 10 year CHD risk of no less than 10%, following 6-week treatment and a possible 6 week extension treatment.

Compare the efficacy of rosuvastatin to atorvastatin in high risk patients with hypercholesterolemia

Research Site

A randomised, double-blind trial to compare the efficacy of rosuvastatin 5 and 10 mg to atorvastatin 10 mg in the treatment of high risk patients with hypercholesterolemia followed by an open label treatment period with rosuvastatin up-titrated to the maximum dose of 20 mg for those patients who do not achieve goal

Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a two-sided significance level of 0.025 on ITT population.

Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.025 on ITT population.

Age Continuous

Gender, Male/Female

Race/Ethnicity, Customized

Low density lipoprotein cholesterol (LDL-C level)

Study Specific Characteristic

triglyceride (TG)  level

Percentage change from baseline in Low density lipoprotein cholesterol (LDL-C) concentration after 6 weeks of treatment comparing rosuvastatin  5mg with atorvastatin 10mg

Percentage change from baseline in Low density lipoprotein cholesterol (LDL-C) concentration after 6 weeks of treatment comparing rosuvastatin 10mg with atorvastatin 10mg

Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.

Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.

Percentage change from baseline in High Density Lipoprotein-Cholesterol (HDL-C) at week 6

Percentage change from baseline in total cholesterol  (TC ) at week 6

Percentage change from baseline in triglycerides (TG) at week 6

Percentage change from baseline in non High Density Lipoprotein-Cholesterol (nonHDL-C) at week 6

Percentage change from baseline in Apolipoprotein B  (ApoB) at week 6

Percentage change from baseline in Apolipoprotein A-I (ApoA-I) at week 6

Percentage change from baseline in total cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at week 6

Percentage change from baseline in Low density lipoprotein cholesterol/High density lipoprotein cholesterol (LDL-C/HDL-C) at week 6

Percentage change from baseline in non High Density lipoprotein cholesterol/High Density lipoprotein cholesterol (nonHDL-C/HDL-C) at week 6

Percentage change from baseline in apolipoprotein B/apolipoprotein A I (ApoB/ApoA-I) at week 6

The percentage of patients achieved LDL-C goal is done in ITT population.
National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:
Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal < 3.36mmol/L(130mg/dL), non-HDL-C goal < 4.14mmol/L (160mg/dL) ;
High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk >20%): LDL-C goal< 2.60mmol/L (100mg/dL), non-HDL-C goal < 3.36mmol/L (130mg/dL)

Percentage of patients achieved ATP III guideline (2001) Low density lipoprotein cholesterol  (LDL-C) goal at week 6

The percentage of patients achieved LDL-C goal is done in ITT population.
National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:
Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal < 3.36mmol/L(130mg/dL); non-HDL-C goal < 4.14mmol/L (160mg/dL) ;
High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk >20%): LDL-C goal< 2.60mmol/L (100mg/dL),non-HDL-C goal < 3.36mmol/L (130mg/dL)

6 weeksPercentage of patients achieved ATP III guideline (2001) non High Density Lipoprotein-Cholesterol (nonHDL-C) goal at week 6

Patients did not achieve NCEP ATP III LDL-C goal at the end of 6 weeks randomised
treatment period, they entered into extension treatment period upon investigator’s discretion.

Percentage of patients achieved National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III guideline (2001) Low Density Lipoprotein-Cholesterol  (LDL-C) goal after titration

Randomised treatment period

Extension treatment period

There is a dietary lead in period before randomization. 934 patients started the dietary lead in period. 436 patients completed this period. The baseline measurement is based on the ITT population. Patients included in ITT population in each arm is : Rosuvastatin 5mg 136, Rosuvastatin 10mg 139 and Atorvastatin 10mg 139.

Arms	Assigned Interventions
Experimental: 1 Rosuvastatin 5mg qd	Drug: Rosuvastatin Capsule/Tablet, oral, qd, 6 or 12 weeks Other Name: Crestor
Experimental: 2 Rosuvastatin 10mg qd	Drug: Rosuvastatin Capsule/Tablet, oral, qd, 6 or 12 weeks Other Name: Crestor
Active Comparator: 3 Atorvastatin 10mg qd	Drug: Atorvastatin Capsule/Tablet, 10mg, oral, qd, 6 weeks Other Name: Lipitor

Compare the efficacy of rosuvastatin to atorvastatin in high risk patients with hypercholesterolemia

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=328&filename=CSR-D356FC00007.pdf

CSR-D356FC00007.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator