COREG MR Versus TOPROL-XL On The Lipid Profile Of Normolipidemic Or Mildly Dyslipidemic Patients With Hypertension

This study has been completed.

Study NCT00273052 Information provided by GlaxoSmithKline

First Received on January 5, 2006. Last Updated on August 11, 2011 History of Changes

Results First Received: December 19, 2008

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Dyslipidaemia Hypertension
Interventions:	Drug: Carvedilol Phosphate modified release formulation Drug: metoprolol succinate

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

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

Participant Flow: Overall Study

	Coreg CR	Toprol XL
STARTED	290	278
COMPLETED	221	190
NOT COMPLETED	69	88
Withdrawal by Subject	16	19
Adverse Event	21	19
Protocol Violation	14	18
Lost to Follow-up	7	25
Lack of Efficacy	6	4
Non-Compliance	3	1
Not specified	2	0
Worsening serum lipid levels	0	2

Baseline Characteristics

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Reporting Groups

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

Baseline Measures

	Coreg CR	Toprol XL	Total
Number of Participants [units: participants]	290	278	568
Age, Customized [units: participants]
< 65 years	260	244	504
>=65 years	30	34	64
Gender [units: participants]
Female	137	133	270
Male	153	145	298
Race/Ethnicity, Customized [units: participants]
Black	24	28	52
White/Caucasian	239	226	465
Other	27	24	51

Outcome Measures

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1. Primary:

Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance Month 6 [ Time Frame: Baseline and Month 6 ]

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2. Primary:

Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Levels by Treatment Group at Maintenance Month 6 [ Time Frame: Baseline and Month 6 ]

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3. Secondary:

Change From Baseline in Log Transformed High Sensitivity C-reactive Protein (Hs-CRP) by Treatment Group at Maintenance Month 6 [ Time Frame: Baseline and Month 6 ]

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4. Secondary:

Change From Baseline in Log Transformed Lipoprotein-associated Phospholipase A2 (LpPLA2) by Treatment Group at Maintenance Month 6 [ Time Frame: Baseline and Month 6 ]

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5. Secondary:

Change From Baseline in Blood Pressure by Treatment Group at Maintenance Month 6 [ Time Frame: Baseline and Month 6 ]

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6. Secondary:

Change From Baseline in Heart Rate by Treatment Group at Maintenance Month 6 [ Time Frame: Baseline and Month 6 ]

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7. Secondary:

Change From Baseline in Weight by Treatment Group at Maintenance Month [ Time Frame: Baseline and Month 6 ]

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8. Secondary:

Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6 [ Time Frame: Baseline and Month 6 ]

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9. Secondary:

Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of g/L at Maintenance Month 6 [ Time Frame: Baseline and Month 6 ]

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10. Secondary:

Change From Baseline in Fasting Insulin (Glycemic Parameter) by Treatment Group at Maintenance Month 6 [ Time Frame: Baseline and Month 6 ]

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11. Secondary:

Change From Baseline in Hemoglobin A1c (HbA1c) (Glycemic Parameter) by Treatment Group at Maintenance Month 6 [ Time Frame: Baseline and Month 6 ]

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12. Secondary:

Change From Baseline in c-Peptide (Glycemic Parameter) by Treatment Group at Maintenance Month 6 [ Time Frame: Baseline and Month 6 ]

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13. Secondary:

Change From Baseline in Homeostasis Model Assessment (Glycemic Parameter) by Treatment Group at Maintenance Month 6 [ Time Frame: Baseline and Month 6 ]

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14. Secondary:

Change From Baseline in Fasting Plasma Glucose (FPG) (Glycemic Parameter) by Treatment Group at Maintenance Month 6 [ Time Frame: Baseline and Month 6 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centres of a multi-centre trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00273052 History of Changes
Other Study ID Numbers:	COR103561
Study First Received:	January 5, 2006
Results First Received:	December 19, 2008
Last Updated:	August 11, 2011
Health Authority:	United States: Food and Drug Administration