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 purpose of this study is to compare the effectiveness and safety of rosuvastatin 5mg in lowering blood cholesterol, compared to one other medicine, atorvastatin 10mg in Asian patients in the UK.

Study of Asian patients with Hypercholesterolaemia in the UK - Rosuvastatin 5mg versus Atorvastatin 10mg

Research Site

Research SIte

A phase IV, 6-week, randomised, double-blind, multicentre, parallel group, comparative study to evaluate the efficacy of rosuvastatin 5mg and atorvastatin 10mg in UK Asian subjects with primary hypercholesterolaemia

Calculated as LDL-C at Week 6 - LDL-C at Week 12] * 100

Age Continuous

Gender, Male/Female

The study achieved only 8% of the randomised target number of patients and for this reason alone was terminated early.  Planned statistical analyses could not be performed. No scientifically valid conclusions can be drawn from the limited study data.

Intention to treat (ITT) population (all randomized patients).

Percentage change in Low Density Lipoprotein - Cholesterol (LDL-C)

The percentage of participants reaching the General Medical Services (GMS) contract target of total cholesterol (TC) <5 mmol/L

The percentage of participants reaching the Joint British Societies’ Guideline (JBS 2) targets of TC <4 mmol/L and LDL-C <2 mmol/L

Risk categories are:
Symptomatic
Asymptomatic, total risk <5%
Asymptomatic, total risk ≥5%, baseline LDL-C<3 mmol/L and baseline TC<5 mmol/L
Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L

Patients are defined as symptomatic if they meet at least 1 of the following criteria:
History of cardiovascular disease
Type II diabetes or diabetes of unknown type
Baseline TC ≥8 mmol/l
Baseline LDL-C ≥6 mmol/l
Baseline systolic BP ≥180 mmHg
Baseline diastolic BP ≥110 mmHg

Total risk is derived from age, sex, TC, systolic BP and smoking status.

The percentage of participants reaching the European (EAS) targets of LDL-C<2.5 or 3.00 mmol/L, depending on risk category, and the combined LDL-C and TC target of LDL-C<2.5 or 3.0 mmol/L and TC<4.5 or 5.0 mmol/L, both depending on risk category.

Derived according to the following formula:  100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6

The percentage change from baseline(week6) in TC

The percentage change from baseline (week 6) in high-density lipoprotein cholesterol (HDL-C)

The percentage of participants reaching the Joint British Societies Guideline (JBS 2) target of TC <4 mmol/L

The percentage change from baseline (week 6)in non-HDL-C

The percentage change from baseline (week 6) in apolipoprotein-B (ApoB)

The percentage change from baseline (week 6) in apolipoprotein-A1 (ApoA1)

The percentage change from baseline (week 6)in LDL-C/HDL-C ratio

The percentage change from baseline (week 6) in TC/HDL-C ratio

The percentage change from baseline(week 6) in non-HDL-C/HDL-C ratio

The percentage change from baseline (week 6) in ApoB/ApoA1 ratio

The percentage of participants reaching the European (EAS) targets of LDL-C<2.5 or 3.00 mmol/L, depending on risk category.

Overall Study

Participants entered an initial 6-week dietary run-in/ wash-out period, after which those with a fasting low density lipoprotein cholesterol (LDL-C) of greater than or equal to 4.00 mmol/L and triglycerides (TG) less than 4.52 mmol/L, were randomised to receive treatment with either rosuvastatin 5 mg plus atorvatstatin , or atorvastatin 10mg

Arms	Assigned Interventions
Active Comparator: rosuvastatin rosuvastatin 5 mg	Drug: rosuvastatin rosuvastatin 5 mg Other Name: Crestor
Active Comparator: atorvastatin atorvastatin 10 mg	Drug: atorvastatin atorvastatin 10 mg

Study of Asian patients with Hypercholesterolaemia in the UK - Rosuvastatin 5mg versus Atorvastatin 10mg

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Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=318&filename=CSR-D3560L00060.pdf

CSR-D3560L00060.pdf

Trial Results Summaries

Contacts

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Investigators

Principal Investigator