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

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

Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Dyslipidemia

Intervention: Carvedilol Phosphate modified release formulation (Drug); metoprolol succinate (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

Summary

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.

Clinical Details

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline to 6 months in HDL-C or triglycerides levels.

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

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

GSK Clinical Trials Call Center, Rio Piedras 00935, Puerto Rico
GSK Clinical Trials Call Center, Ponce 00717, Puerto Rico
GSK Clinical Trials Call Center, Rio Grande 00745, Puerto Rico
GSK Clinical Trials Call Center, Birmingham, Alabama 35211, United States
GSK Clinical Trials Call Center, Birmingham, Alabama 35209, United States
GSK Clinical Trials Call Center, Birmingham, Alabama 35242, United States
GSK Clinical Trials Call Center, Montgomery, Alabama 36109, United States
GSK Clinical Trials Call Center, Birmingham, Alabama 35205, United States
GSK Clinical Trials Call Center, Calgary, Alberta T3E 0C5, Canada
GSK Clinical Trials Call Center, Calgary, Alberta T2E 7C5, Canada
GSK Clinical Trials Call Center, Edmonton, Alberta T5A 0A3, Canada
GSK Clinical Trials Call Center, Scottsdale, Arizona 85251, United States
GSK Clinical Trials Call Center, Chandler, Arizona 85224, United States
GSK Clinical Trials Call Center, Phoenix, Arizona 85014, United States
GSK Clinical Trials Call Center, Tucson, Arizona 85723, United States
GSK Clinical Trials Call Center, Phoenix, Arizona 85209, United States
GSK Clinical Trials Call Center, Tucson, Arizona 85741, United States
GSK Clinical Trials Call Center, Mesa, Arizona 85213, United States
GSK Clinical Trials Call Center, Mesa, Arizona 85201, United States
GSK Clinical Trials Call Center, Fayetteville, Arkansas 72701, United States
GSK Clinical Trials Call Center, Little Rock, Arkansas 72205, United States
GSK Clinical Trials Call Center, Little Rock, Arkansas 72205, United States
GSK Clinical Trials Call Center, San Diego, California 92128, United States
GSK Clinical Trials Call Center, Los Angeles, California 90057, United States
GSK Clinical Trials Call Center, Mission Viejo, California 92691, United States
GSK Clinical Trials Call Center, Healdsburg, California 95448, United States
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GSK Clinical Trials Call Center, Irvine, California 92618, United States
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GSK Clinical Trials Call Center, Jacksonville, Florida 32259, United States
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GSK Clinical Trials Call Center, Lewisburg, West Virginia 24901, United States

Additional Information

Starting date: December 2005
Last updated: June 26, 2007

Page last updated: June 20, 2008

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