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

This study will assess if customizing the start dose of rosuvastatin appropriate for the degree of LDL-C reduction required, would achieve LDL-C target of ≤ 2.0 mmol/L quickly with either no titration or just one titration step after 6 weeks of therapy in type 2 diabetic patients previously treated with another statin and not at LDL-C targets.

A Diabetes Study to Treat A Population previously Not at Target

Research Site

12-week, open-label, multi-center, prospective study evaluating the effect of individualizing starting doses of rosuvastatin according to baseline LDL (low density lipoprotein)-cholesterol levels on achieving cholesterol targets in type 2 diabetic patients

The number of subjects achieving Canadian  Low density lipoprotein cholesterol (LDL-C) target goals (i.e. LDL-C ≤ 2.0 mmol/L) over the total number subjects treated after 12 weeks of rosuvastatin therapy multiplied by 100

Age Continuous

Gender, Male/Female

Race, Customized

Body Mass Index

Study Specific Characteristic

Waistline circumference

Percentage of subjects achieving Canadian Low density lipoprotein cholesterol (LDL-C)  target goals (i.e. LDL-C ≤ 2.0 mmol/L) after 12 weeks of rosuvastatin therapy

Proportion of subjects achieving  total cholesterol (TC)/ High-density lipoprotein cholesterol (HDLC)  ratio (i.e. TC/HDL < 4.0 mmol/L) at 6 and 12 weeks of treatment

Percentage of subjects achieving total cholesterol (TC)/ High-density lipoprotein cholesterol (HDLC)  ratio (i.e. TC/HDL < 4.0 mmol/L) at 6 and 12 weeks of treatment

Mean percent change in total cholesterol (TC),  Low density lipoprotein cholesterol (LDL-C), High-density lipoprotein cholesterol (HDLC) , TC/HDL-C ratio, Non-HDL-C, Triglycerides and Apolipoprotein B (ApoB) /Apolipoprotein A1 (ApoA-1) ratio

Mean high sensitivity C-reactive protein (hsCRP)  value at week 6 and 12

Incidence of adverse events and abnormal laboratory values after 12 weeks of therapy

Overall Study

Following enrolment, at Visit 1 the patients' Low Density Lipoprotein Cholesterol (LDL-C) value was baselined. If LDL-C value from Visit 1 was > 2.00, but ≤ 2.50 mmol/L:  patients received Rosuvastatin (RSV)10 mg under the RSV 10 mg arm. If LDL-C value from Visit 1 was > 2.50 mmol/L:  patients received Rosuvastatin 20 mg under the RSV 20 mg arm.

Arms	Assigned Interventions
Experimental: Rosuvastatin 1 titrated	Drug: Rosuvastatin Oral Other Name: Crestor
Experimental: Rosuvastatin 2 Non-titrated	Drug: Rosuvastatin Oral Other Name: Crestor

A Diabetes Study to Treat A Population previously Not at Target - ADAPT

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Documents available

http://www.clinicalstudypatient.ca

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=321&filename=CSR-D3560L00072.pdf

CSR-D3560L00072.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator