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

March 19, 2018 updated by: GlaxoSmithKline

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

514

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3C 3P1
        • GSK Investigational Site
      • Calgary, Alberta, Canada, T2E 7C5
        • GSK Investigational Site
      • Edmonton, Alberta, Canada, T5A 4L8
        • GSK Investigational Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1E 2E2
        • GSK Investigational Site
    • Nova Scotia
      • Truro, Nova Scotia, Canada, B2N 1L2
        • GSK Investigational Site
    • Ontario
      • Brampton, Ontario, Canada, L6T 3T1
        • GSK Investigational Site
      • London, Ontario, Canada, N5W 6A2
        • GSK Investigational Site
      • Newmarket, Ontario, Canada, L3Y 5G8
        • GSK Investigational Site
      • Peterborough, Ontario, Canada, K9J 7B3
        • GSK Investigational Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • GSK Investigational Site
      • Sudbury, Ontario, Canada, P3E 1H5
        • GSK Investigational Site
      • Sudbury, Ontario, Canada, P3C 5K7
        • GSK Investigational Site
    • Quebec
      • Gatineau, Quebec, Canada, J8Y 6S8
        • GSK Investigational Site
      • Mirabel, Quebec, Canada, J7J 2K8
        • GSK Investigational Site
      • Trois Rivieres, Quebec, Canada, G8T 7A1
        • GSK Investigational Site
  • Puerto Rico
      • Ponce, Puerto Rico, 731
        • GSK Investigational Site
      • Rio Grande, Puerto Rico, 00745
        • GSK Investigational Site
      • Rio Piedras, Puerto Rico, 00935
        • GSK Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • GSK Investigational Site
      • Birmingham, Alabama, United States, 35209
        • GSK Investigational Site
      • Birmingham, Alabama, United States, 35242
        • GSK Investigational Site
      • Birmingham, Alabama, United States, 35211
        • GSK Investigational Site
      • Montgomery, Alabama, United States, 36106
        • GSK Investigational Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • GSK Investigational Site
      • Mesa, Arizona, United States, 85201
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85014
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85029
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85723
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85741
        • GSK Investigational Site
    • Arkansas
      • Fayetteville, Arkansas, United States, 72701
        • GSK Investigational Site
      • Little Rock, Arkansas, United States, 72205
        • GSK Investigational Site
    • California
      • Carmichael, California, United States, 95608
        • GSK Investigational Site
      • Healdsburg, California, United States, 95448
        • GSK Investigational Site
      • Irvine, California, United States, 92618
        • GSK Investigational Site
      • La Jolla, California, United States, 92037
        • GSK Investigational Site
      • Los Angeles, California, United States, 90057
        • GSK Investigational Site
      • Los Angeles, California, United States, 90502
        • GSK Investigational Site
      • Mission Viejo, California, United States, 92691
        • GSK Investigational Site
      • Poway, California, United States, 92064
        • GSK Investigational Site
      • Sacramento, California, United States, 95816
        • GSK Investigational Site
      • San Diego, California, United States, 92177
        • GSK Investigational Site
      • Spring Valley, California, United States, 91978
        • GSK Investigational Site
      • Stockton, California, United States, 95204
        • GSK Investigational Site
      • Torrance, California, United States, 90503
        • GSK Investigational Site
      • Vista, California, United States, 92084
        • GSK Investigational Site
    • Connecticut
      • Avon, Connecticut, United States, 06001
        • GSK Investigational Site
    • Florida
      • Altamonte Springs, Florida, United States, 32714
        • GSK Investigational Site
      • Clearwater, Florida, United States, 33755
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33308
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32216
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32205
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32259
        • GSK Investigational Site
      • Pembroke Pines, Florida, United States, 33024
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • GSK Investigational Site
      • Marietta, Georgia, United States, 30067
        • GSK Investigational Site
      • Roswell, Georgia, United States, 30076
        • GSK Investigational Site
    • Illinois
      • Aurora, Illinois, United States, 60504
        • GSK Investigational Site
      • Chicago, Illinois, United States, 60611
        • GSK Investigational Site
      • Gillespie, Illinois, United States, 62033
        • GSK Investigational Site
      • Vernon Hills, Illinois, United States, 60061
        • GSK Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • GSK Investigational Site
      • Indianapolis, Indiana, United States, 46260
        • GSK Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67214
        • GSK Investigational Site
      • Wichita, Kansas, United States, 67205
        • GSK Investigational Site
    • Louisiana
      • Bossier City, Louisiana, United States, 71111
        • GSK Investigational Site
    • Maine
      • Auburn, Maine, United States, 04210
        • GSK Investigational Site
    • Massachusetts
      • Natick, Massachusetts, United States, 01760
        • GSK Investigational Site
      • Taunton, Massachusetts, United States, 02780.
        • GSK Investigational Site
      • West Yarmouth, Massachusetts, United States, 02673
        • GSK Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48235
        • GSK Investigational Site
    • Minnesota
      • Brooklyn Center, Minnesota, United States, 55430
        • GSK Investigational Site
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • GSK Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • GSK Investigational Site
      • Springfield, Missouri, United States, 65807
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • GSK Investigational Site
      • Omaha, Nebraska, United States, 68144
        • GSK Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89014
        • GSK Investigational Site
      • Las Vegas, Nevada, United States, 89119
        • GSK Investigational Site
      • Las Vegas, Nevada, United States, 89128
        • GSK Investigational Site
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • GSK Investigational Site
      • Elizabeth, New Jersey, United States, 07202
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • GSK Investigational Site
      • Albuquerque, New Mexico, United States, 87108
        • GSK Investigational Site
    • New York
      • East Syracuse, New York, United States, 13057
        • GSK Investigational Site
      • Endwell, New York, United States, 13760
        • GSK Investigational Site
      • Fishkill, New York, United States, 12524
        • GSK Investigational Site
      • New York, New York, United States, 10021
        • GSK Investigational Site
      • New York, New York, United States, 10016
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • GSK Investigational Site
      • Raleigh, North Carolina, United States, 27612
        • GSK Investigational Site
      • Statesville, North Carolina, United States, 28625
        • GSK Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • GSK Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45246
        • GSK Investigational Site
      • Cincinnati, Ohio, United States, 45245
        • GSK Investigational Site
      • Cleveland, Ohio, United States, 44195
        • GSK Investigational Site
      • Kettering, Ohio, United States, 45429
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • GSK Investigational Site
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16508
        • GSK Investigational Site
      • Warminster, Pennsylvania, United States, 18974
        • GSK Investigational Site
      • West Chester, Pennsylvania, United States, 19380
        • GSK Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • GSK Investigational Site
      • Greer, South Carolina, United States, 29651
        • GSK Investigational Site
      • Hartsville, South Carolina, United States, 29550
        • GSK Investigational Site
      • Simpsonville, South Carolina, United States, 29681
        • GSK Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • GSK Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • GSK Investigational Site
    • Texas
      • Corpus Christi, Texas, United States, 78404
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78258
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78237
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84109
        • GSK Investigational Site
    • Virginia
      • Burke, Virginia, United States, 22015
        • GSK Investigational Site
      • Galax, Virginia, United States, 24333
        • GSK Investigational Site
      • Manassas, Virginia, United States, 22015
        • GSK Investigational Site
      • Newport News, Virginia, United States, 23606
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23294
        • GSK Investigational Site
      • Springfield, Virginia, United States, 22151
        • GSK Investigational Site
      • Virginia Beach, Virginia, United States, 23451
        • GSK Investigational Site
    • Washington
      • Walla Walla, Washington, United States, 99362
        • GSK Investigational Site
    • West Virginia
      • Lewisburg, West Virginia, United States, 24901
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carvedilol Phosphate modified release formulation
Drug: Carvedilol Phosphate modified release formulation
Active Comparator: metoprolol succinate
Drug: metoprolol succinate
Other Names:
  • Carvedilol Phosphate modified release formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Month 6
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.
Baseline and Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Month 6
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.
Baseline and Month 6
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.
Baseline and Month 6
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)
Baseline and Month 6
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.
Baseline and Month 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.
Baseline and Month 6
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.
Baseline and Month 6
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.
Baseline and Month 6
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.
Baseline and Month 6
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.
Baseline and Month 6
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.
Baseline and Month 6
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.
Baseline and Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 5, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 28, 2007

Study Registration Dates

First Submitted

January 5, 2006

First Submitted That Met QC Criteria

January 5, 2006

First Posted (Estimate)

January 9, 2006

Study Record Updates

Last Update Posted (Actual)

June 25, 2018

Last Update Submitted That Met QC Criteria

March 19, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COR103561

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Statistical Analysis Plan
    Information identifier: COR103561
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Clinical Study Report
    Information identifier: COR103561
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Individual Participant Data Set
    Information identifier: COR103561
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Annotated Case Report Form
    Information identifier: COR103561
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Dataset Specification
    Information identifier: COR103561
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Informed Consent Form
    Information identifier: COR103561
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Study Protocol
    Information identifier: COR103561
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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