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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Carvedilol Phosphate modified release formulation; Drug: metoprolol succinate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00273052

COR103561

Details and patient eligibility

About

This study was designed to determine whether treatment with COREG MR is more effective at maintaining a better lipid profile than treatment with TOPROL-XL for hypertension.

Enrollment: 514 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented history of hypertension
• Triglycerides of 120-400 mg/mL
• LDLc levels not requiring lipid lowering medication.

Exclusion criteria

• Has known contraindication to alpha- or beta-blocker therapy.
• Has taken any non-ocular beta-blockers within three months before screening.
• Has Type I or II diabetes.
• Taking lipid lowering medications.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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514 participants in 2 patient groups

Carvedilol Phosphate modified release formulation

Experimental group

Treatment:

Drug: Carvedilol Phosphate modified release formulation

metoprolol succinate

Active Comparator group

Treatment:

Drug: metoprolol succinate