COREG MR Versus TOPROL-XL On The Lipid Profile Of Normoli... | NCT00273052

Official Title

A Randomized, Double-Blind, Multi-Center Study Comparing the Effects of Carvedilol Phosphate Modified Release Formulation (COREG- MR) With Metoprolol Succinate (TOPROL XL) on the Lipid Profile in Normolipidemic, or Mildly Dyslipidemic Hypertensive Patients

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

Arm Groups

Label	Type	Description	Intervention Names
Carvedilol Phosphate modified release formulation	Experimental		Drug: Carvedilol Phosphate modified release formulation
metoprolol succinate	Active Comparator		Drug: metoprolol succinate

Name	Type	Description	Arm Group Labels	Other Names
Carvedilol Phosphate modified release formulation	Drug		Carvedilol Phosphate modified release formulation
metoprolol succinate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance Month 6	Blood draw for triglyceride levels. Full beta quantification test performed which uses ultracentrifugation to partially separate lipoprotein classes and is the basis for the reference methods. Change = Month 6 value minus Baseline value.	Baseline and Month 6
Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Levels by Treatment Group at Maintenance Month 6	Blood draw for HDL-C levels. Full beta Quant test performed with HDL subclasses. Change = Month 6 value minus Baseline value.	Baseline and Month 6

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Log Transformed High Sensitivity C-reactive Protein (Hs-CRP) by Treatment Group at Maintenance Month 6	Blood draw for hs-CRP. Change = Month 6 value minus Baseline value.	Baseline and Month 6
Change From Baseline in Log Transformed Lipoprotein-associated Phospholipase A2 (LpPLA2) by Treatment Group at Maintenance Month 6

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Birmingham	Alabama	35205	United States
GSK Investigational Site

References Module

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
COR103561	Statistical Analysis Plan	View IPD

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Coreg CR	Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
FG001	Toprol XL	Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Coreg CR	Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
BG001	Toprol XL	Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
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, Customized

Number

participants

Title

Denominators

Categories

< 65 years

Title	Measurements
	BG000260 BG001244 BG002504

>=65 years

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000137 BG001133 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Black

Title	Measurements
	BG00024 BG00128 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

Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance Month 6

Blood draw for triglyceride levels. Full beta quantification test performed which uses ultracentrifugation to partially separate lipoprotein classes and is the basis for the reference methods. Change = Month 6 value minus Baseline value.

The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).

Posted

Number

mg/dL

Baseline and Month 6

ID	Title	Description
OG000	Coreg CR	Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
OG001	Toprol XL	Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)

Units	Counts
Participants	OG000235 OG001206

Title

Denominators

Categories

Title	Measurements
	OG0002.65 OG00110.39

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.0141		Median Difference (Net)	-8.026				95	-15.35	-0.67			Median difference = Coreg CR - Toprol XL		Superiority or Other

Primary

Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Levels by Treatment Group at Maintenance Month 6

Blood draw for HDL-C levels. Full beta Quant test performed with HDL subclasses. Change = Month 6 value minus Baseline value.

Posted

Number

mg/dL

Baseline and Month 6

ID	Title	Description
OG000	Coreg CR	Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
OG001	Toprol XL	Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Log Transformed High Sensitivity C-reactive Protein (Hs-CRP) by Treatment Group at Maintenance Month 6

Blood draw for hs-CRP. Change = Month 6 value minus Baseline value.

Posted

Number

mg/dL

Baseline and Month 6

ID	Title	Description
OG000	Coreg CR	Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
OG001	Toprol XL	Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Log Transformed Lipoprotein-associated Phospholipase A2 (LpPLA2) by Treatment Group at Maintenance Month 6

Blood draw for LpPLA2 activity. Change = Month 6 value minus Baseline value.

Posted

Number

mcmol/min/L

Baseline and Month 6

ID	Title	Description
OG000	Coreg CR	Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
OG001	Toprol XL	Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Blood Pressure by Treatment Group at Maintenance Month 6

Manual physical examination (cuff blood pressure). Change = Month 6 value minus Baseline value.

Posted

Number

mm Hg

Baseline and Month 6

ID	Title	Description
OG000	Coreg CR	Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
OG001	Toprol XL	Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Heart Rate by Treatment Group at Maintenance Month 6

Manual physical examination. Change = Month 6 value minus Baseline value. (BPM=beats per minute)

Posted

Number

bpm

Baseline and Month 6

ID	Title	Description
OG000	Coreg CR	Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
OG001	Toprol XL	Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Weight by Treatment Group at Maintenance Month

Manual physical examination. Change = Month 6 value minus Baseline value.

Posted

Number

Baseline and Month 6

ID	Title	Description
OG000	Coreg CR	Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
OG001	Toprol XL	Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6

Blood draw for lipid levels. Full beta Quant test performed with HDL subclasses and IDL. IDL=Intermediate density lipoproteins, LDL=Low-density lipoprotein, VLDL=Very Low density lipoprotein, HDL=High-density lipoprotein. Change = Month 6 value minus Baseline value.

Posted

Number

mg/dL

Baseline and Month 6

ID	Title	Description
OG000	Coreg CR	Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
OG001	Toprol XL	Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)

Units	Counts
Participants

Secondary

Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of g/L at Maintenance Month 6

Blood draw for lipid levels. Full beta Quant test performed. Change = Month 6 value minus Baseline value.

Posted

Number

g/L

Baseline and Month 6

ID	Title	Description
OG000	Coreg CR	Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
OG001	Toprol XL	Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Fasting Insulin (Glycemic Parameter) by Treatment Group at Maintenance Month 6

Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.

Posted

Number

uIU/mL

Baseline and Month 6

ID	Title	Description
OG000	Coreg CR	Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
OG001	Toprol XL	Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)

Units	Counts

Secondary

Change From Baseline in Hemoglobin A1c (HbA1c) (Glycemic Parameter) by Treatment Group at Maintenance Month 6

Posted

Number

Percent Change

Baseline and Month 6

ID	Title	Description
OG000	Coreg CR	Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
OG001	Toprol XL	Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)

Units	Counts

Secondary

Change From Baseline in c-Peptide (Glycemic Parameter) by Treatment Group at Maintenance Month 6

Posted

Number

ng/mL

Baseline and Month 6

ID	Title	Description
OG000	Coreg CR	Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
OG001	Toprol XL	Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)

Units	Counts

Secondary

Change From Baseline in Homeostasis Model Assessment (Glycemic Parameter) by Treatment Group at Maintenance Month 6

Posted

Number

Percent Change

Baseline and Month 6

ID	Title	Description
OG000	Coreg CR	Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
OG001	Toprol XL	Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)

Units	Counts

Secondary

Change From Baseline in Fasting Plasma Glucose (FPG) (Glycemic Parameter) by Treatment Group at Maintenance Month 6

Posted

Number

mg/dL

Baseline and Month 6

ID	Title	Description
OG000	Coreg CR	Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
OG001	Toprol XL	Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Coreg CR	Results include only treatment emergent events.			8		186
EG001	Toprol XL	Results include only treatment emergent events.			5		160

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected290 at risk EG0011 affected278 at risk
Chest discomfort	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected290 at risk EG0010 affected278 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected290 at risk EG0010 affected278 at risk
Depression suicidal	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected290 at risk EG0010 affected278 at risk
Gastroesophagael reflux disease	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected290 at risk EG0010 affected278 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected290 at risk EG0011 affected278 at risk
Hypertension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected290 at risk EG0010 affected278 at risk
Myocardial Infarction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected290 at risk EG0010 affected278 at risk
Orthostatic hypotension	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected290 at risk EG0011 affected278 at risk
Palpitations	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected290 at risk EG0010 affected278 at risk
Peridiverticular abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected290 at risk EG0011 affected278 at risk
Presyncope	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected290 at risk EG0011 affected278 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected290 at risk EG0010 affected278 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Headache	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00042 affected290 at risk EG00133 affected278 at risk
Edema Peripheral	General disorders	MedDRA 10.0	Systematic Assessment	EG00029 affected290 at risk EG00125 affected278 at risk
Fatigue	General disorders	MedDRA 10.0	Systematic Assessment	EG00022 affected290 at risk EG00129 affected278 at risk
Dizziness	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00028 affected290 at risk EG00118 affected278 at risk
Nasopharyngitis	Infections and infestations		Systematic Assessment	EG00016 affected290 at risk EG00117 affected278 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00019 affected290 at risk EG00112 affected278 at risk
Nausea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00018 affected290 at risk EG00111 affected278 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00012 affected290 at risk EG00115 affected278 at risk

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D050198	Phenoxypropanolamines
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D020005	Propanols
D000588	Amines