A Diabetes Study to Treat A Population Previously Not at... | NCT00747149

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Rosuvastatin 1	Experimental	titrated	Drug: Rosuvastatin
Rosuvastatin 2	Experimental	Non-titrated	Drug: Rosuvastatin

Name	Type	Description	Arm Group Labels	Other Names
Rosuvastatin	Drug	Oral	Rosuvastatin 1 Rosuvastatin 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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	12 Weeks

Secondary Outcomes

Measure	Description	Time Frame
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	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	6 and 12 Weeks

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Davide Meani	AstraZeneca	Study Director
David Lau, MD	Private Practice	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Calgary	Alberta		Canada
Research Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Rosuvastatin Titrated	10 mg rosuvastatin (RSV) as initial dose followed by 20 mg RSV as titrated dose or 20 mg rosuvastatin (RSV) as initial dose followed by 40 mg RSV as titrated dose
FG001	Rosuvastatin Non-titrated

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Rosuvastatin 10 mg (Initial)	10 mg rosuvastatin (RSV) as initial dose
BG001	Rosuvastatin 20 mg (Initial)	20 mg RSV as initial dose
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00063.2± 10.9 BG00162.6± 10.5 BG00262.9± 10.7

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000150 BG001145 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG000288 BG001245 BG002

Body Mass Index

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

BMI

Title	Measurements
	BG00032.50± 6.89 BG00132.27± 6.72 BG002

Waistline circumference

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG000106.7± 14.9 BG001106.7± 15.9 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

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

Posted

Mean

95% Confidence Interval

Percentage

12 Weeks

ID	Title	Description
OG000	Rosuvastatin 10 mg (Initial)	At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
OG001	Rosuvastatin 20 mg (Initial)	At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
OG002	Rosuvastatin 20 mg (Titrated)	At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
OG003	Rosuvastatin 40 mg (Titrated)	At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.

Units	Counts
Participants	OG000225 OG001176 OG00275 OG003

Title

Denominators

Categories

Title	Measurements
	OG00087± 82(82 to 91) OG00187± 81(81 to 91) OG00276± 65(65 to 84)

Secondary

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

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

Not Posted

Mean

95% Confidence Interval

Percentage of participants

6 and 12 Weeks

Secondary

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

Not Posted

Mean

95% Confidence Interval

Percentage

6 and 12 Weeks

Secondary

Mean High Sensitivity C-reactive Protein (hsCRP) Value at Week 6 and 12

Not Posted

Mean

95% Confidence Interval

value mg/L

6 and 12 Weeks

Secondary

Incidence of Adverse Events and Abnormal Laboratory Values After 12 Weeks of Therapy

Not Posted

Number

Participants

6 and 12 Weeks

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Rosuvastatin 10 mg (Initial)	10 mg rosuvastatin (RSV) as initial dose	4	319	14	319
EG001	Rosuvastatin 10 mg (Continued, Non-titrated)	10 mg RSV as a continued, non-titrated dose	2	232	4	232
EG002	Rosuvastatin 20 mg (Initial)	20 mg RSV as initial dose	0	279	9	279
EG003	Rosuvastatin 20 mg (Continued, Non-titrated)	20 mg RSV as continued, non-titrated dose	0	182	3	182
EG004	Rosuvastatin 20 mg (Titrated)	20 mg RSV as titrated dose	1	75	2	75
EG005	Rosuvastatin 40 mg (Titrated)	20 mg RSV as titrated dose	1	78	0	78

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Labyrinthitis	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected319 at risk EG0011 affected232 at risk EG0020 affected279 at risk EG0030 affected182 at risk EG0040 affected75 at risk EG0050 affected78 at risk
Cellulitis	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected319 at risk EG0010 affected232 at risk EG0020 affected279 at risk EG003
Renal Colic	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected319 at risk EG0010 affected232 at risk EG0020 affected279 at risk EG003
Chemical Poisoning	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected319 at risk EG0011 affected232 at risk EG0020 affected279 at risk EG003
Urinary Tract Infection	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected319 at risk EG0010 affected232 at risk EG0020 affected279 at risk EG003
Aortic Aneurysm Rupture	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected319 at risk EG0010 affected232 at risk EG0020 affected279 at risk EG003
Cerebrovascular Accident	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected319 at risk EG0010 affected232 at risk EG0020 affected279 at risk EG003
Urinary Retention	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected319 at risk EG0010 affected232 at risk EG0020 affected279 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected319 at risk EG0010 affected232 at risk EG0026 affected279 at risk EG0032 affected182 at risk EG0040 affected75 at risk EG0050 affected78 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected319 at risk EG0011 affected232 at risk EG0022 affected279 at risk EG003
Bronchitis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected319 at risk EG0013 affected232 at risk EG0021 affected279 at risk EG003

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes
D006845	Hydrocarbons, Fluorinated
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D013450	Sulfones
D013457	Sulfur Compounds
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds