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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Carvedilol Phosphate modified release formulation
• Drug: metoprolol succinate

Primary Measures

• Change from baseline to 6 months in HDL-C or triglycerides levels.
  • Time Frame: 6 Months
    

Secondary Measures

• Change from baseline to 6 months in lipid profile, glycemic parameters, C-reactive protein, LpPLA2, blood pressure and heart rate.
  • Time Frame: 6 months
    

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00273052

Study ID Number: COR103561

ClinicalTrials.gov Identifier: NCT00273052

Health Authority: United States: Food and Drug Administration