EU Clinical Trial Information System (CTIS)

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

The primary objective of this study is to compare the effect of rosuvastatin 10mg with atorvastatin 10mg after 6 weeks of treatment in the ratio of ApoB/ApoA1 in subjects with metabolic syndrome.

ROMEO (Rosuvastatin in Metabolic syndrOme)

Research Site

A 6-week, randomised, open-label, parallel group, multi-centre study to compare the efficacy of rosuvastatin 10mg with atorvastatin 10mg in the treatment of metabolic syndrome subjects with raised LDL-C

Samples for evaluation from all investigational sites will be delivered by courier to the central laboratory within 24 hours of blood being drawn. This outcome will be calculated by using the result of ApoB and ApoA1.

Age Continuous

Gender, Male/Female

Percentage change from baseline in ratio of Apolipoprotein (ApoB/ApoA1) at Week 6

Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C target goal. LDL-C target goals are <70mg/dl, <100mg/dl and <130mg/dl according to their baseline conditions (presence of Coronary heart disease and risk factors and grade of Framingham 10-Year risk).

Percentage of subjects reaching their LDL-C target goal

Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C & non HDL-C target goal.

Percentage of subjects reaching their Low-Density Lipoprotein-C (LDL-C) and non High-Density Lipoprotein-C (HDL-C) target goal

Using laboratory test, mean change of glucose level was investigated.

Percentage change of Glucose level

HOMA-R was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: HOMA-R = insulin* glucose/22.5

Percentage change of Insulin resistance using HOMA-R

QUICKI was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: QUICKI = 1/[log(insulin) + log(glucose)].

Percentage change of insulin resistance using QUICKI

Calculate the percentage reduction of LDL-C

Percentage reduction of Low-Density Lipoprotein-C (LDL-C)

Calculate the percentage change of total cholesterol level

Percentage change of Total Cholesterol (TC)

Calculate the percentage change of HDL-C level

Percentage change of High-Density Lipoprotein-C (HDL-C)

Calculate the percentage change of Triglycerides.

Percentage change of Triglycerides (TG)

Calculate the percentage change of Apolipoprotein A1

Percentage change of Apolipoprotein A1 (ApoA1)

Calculate the percentage change of apolipoprotein B

Percentage change of apolipoprotein B (ApoB)

Overall Study

Enrolled patients to be randomized should complete 6-week dietary run-in periods. Also, LDL level should be ≥ 130mg/dl &  < 220mg/dl and triglyceride should be < 500mg/dl.

Arms	Assigned Interventions
Experimental: Rosuvastatin	Drug: Rosuvastatin 10mg Other Name: Crestor
Active Comparator: Atorvastatin	Drug: Atorvastatin 10mg

ROMEO (Rosuvastatin in Metabolic syndrOme)

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Research Site

Research Site

Research Site

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=319&filename=CSR-D3560L00061.pdf

CSR-D3560L00061.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator