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Completed

NCT Number: NCT00273052

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carvedilol Phosphate modified release formulation

Drug

Metoprolol succinate

Drug

Other names: Carvedilol Phosphate modified release formulation

Primary outcomes

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and Month 6

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

Secondary outcomes

  1. 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

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

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

    Time frame: Baseline and Month 6

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

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

    Time frame: Baseline and Month 6

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

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

    Time frame: Baseline and Month 6

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

  5. Change From Baseline in Weight by Treatment Group at Maintenance Month

    Time frame: Baseline and Month 6

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

  6. 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

    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.

  7. 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

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

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jan 9, 2006
Registry last updated
Jun 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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