COREG MR Versus TOPROL-XL On The Lipid Profile Of Normolipidemic Or Mildly Dyslipidemic Patients With Hypertension
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
1 other identifier
interventional
514
3 countries
120
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hypertension
Started Jan 2006
Typical duration for phase_3 hypertension
120 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2006
CompletedStudy Start
First participant enrolled
January 5, 2006
CompletedFirst Posted
Study publicly available on registry
January 9, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2007
CompletedResults Posted
Study results publicly available
February 1, 2010
CompletedJune 25, 2018
March 1, 2018
1.9 years
January 5, 2006
December 19, 2008
March 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance 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
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 Outcomes (12)
Change From Baseline in Log Transformed High Sensitivity C-reactive Protein (Hs-CRP) by Treatment Group at Maintenance Month 6
Baseline and Month 6
Change From Baseline in Log Transformed Lipoprotein-associated Phospholipase A2 (LpPLA2) by Treatment Group at Maintenance Month 6
Baseline and Month 6
Change From Baseline in Blood Pressure by Treatment Group at Maintenance Month 6
Baseline and Month 6
Change From Baseline in Heart Rate by Treatment Group at Maintenance Month 6
Baseline and Month 6
Change From Baseline in Weight by Treatment Group at Maintenance Month
Baseline and Month 6
- +7 more secondary outcomes
Study Arms (2)
Carvedilol Phosphate modified release formulation
EXPERIMENTALmetoprolol succinate
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Documented history of hypertension
- Triglycerides of 120-400 mg/mL
- LDLc levels not requiring lipid lowering medication.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (120)
GSK Investigational Site
Birmingham, Alabama, 35205, United States
GSK Investigational Site
Birmingham, Alabama, 35209, United States
GSK Investigational Site
Birmingham, Alabama, 35211, United States
GSK Investigational Site
Birmingham, Alabama, 35242, United States
GSK Investigational Site
Montgomery, Alabama, 36106, United States
GSK Investigational Site
Chandler, Arizona, 85224, United States
GSK Investigational Site
Mesa, Arizona, 85201, United States
GSK Investigational Site
Phoenix, Arizona, 85014, United States
GSK Investigational Site
Phoenix, Arizona, 85029, United States
GSK Investigational Site
Tucson, Arizona, 85723, United States
GSK Investigational Site
Tucson, Arizona, 85741, United States
GSK Investigational Site
Fayetteville, Arkansas, 72701, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Carmichael, California, 95608, United States
GSK Investigational Site
Healdsburg, California, 95448, United States
GSK Investigational Site
Irvine, California, 92618, United States
GSK Investigational Site
La Jolla, California, 92037, United States
GSK Investigational Site
Los Angeles, California, 90057, United States
GSK Investigational Site
Los Angeles, California, 90502, United States
GSK Investigational Site
Mission Viejo, California, 92691, United States
GSK Investigational Site
Poway, California, 92064, United States
GSK Investigational Site
Sacramento, California, 95816, United States
GSK Investigational Site
San Diego, California, 92177, United States
GSK Investigational Site
Spring Valley, California, 91978, United States
GSK Investigational Site
Stockton, California, 95204, United States
GSK Investigational Site
Torrance, California, 90503, United States
GSK Investigational Site
Vista, California, 92084, United States
GSK Investigational Site
Avon, Connecticut, 06001, United States
GSK Investigational Site
Altamonte Springs, Florida, 32714, United States
GSK Investigational Site
Clearwater, Florida, 33755, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33308, United States
GSK Investigational Site
Jacksonville, Florida, 32205, United States
GSK Investigational Site
Jacksonville, Florida, 32216, United States
GSK Investigational Site
Jacksonville, Florida, 32259, United States
GSK Investigational Site
Pembroke Pines, Florida, 33024, United States
GSK Investigational Site
Atlanta, Georgia, 30308, United States
GSK Investigational Site
Marietta, Georgia, 30067, United States
GSK Investigational Site
Roswell, Georgia, 30076, United States
GSK Investigational Site
Aurora, Illinois, 60504, United States
GSK Investigational Site
Chicago, Illinois, 60611, United States
GSK Investigational Site
Gillespie, Illinois, 62033, United States
GSK Investigational Site
Vernon Hills, Illinois, 60061, United States
GSK Investigational Site
Evansville, Indiana, 47714, United States
GSK Investigational Site
Indianapolis, Indiana, 46260, United States
GSK Investigational Site
Wichita, Kansas, 67205, United States
GSK Investigational Site
Wichita, Kansas, 67214, United States
GSK Investigational Site
Bossier City, Louisiana, 71111, United States
GSK Investigational Site
Auburn, Maine, 04210, United States
GSK Investigational Site
Natick, Massachusetts, 01760, United States
GSK Investigational Site
Taunton, Massachusetts, 02780., United States
GSK Investigational Site
West Yarmouth, Massachusetts, 02673, United States
GSK Investigational Site
Detroit, Michigan, 48235, United States
GSK Investigational Site
Brooklyn Center, Minnesota, 55430, United States
GSK Investigational Site
Olive Branch, Mississippi, 38654, United States
GSK Investigational Site
Springfield, Missouri, 65807, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Omaha, Nebraska, 68134, United States
GSK Investigational Site
Omaha, Nebraska, 68144, United States
GSK Investigational Site
Henderson, Nevada, 89014, United States
GSK Investigational Site
Las Vegas, Nevada, 89119, United States
GSK Investigational Site
Las Vegas, Nevada, 89128, United States
GSK Investigational Site
Brick, New Jersey, 08724, United States
GSK Investigational Site
Elizabeth, New Jersey, 07202, United States
GSK Investigational Site
Albuquerque, New Mexico, 87102, United States
GSK Investigational Site
Albuquerque, New Mexico, 87108, United States
GSK Investigational Site
East Syracuse, New York, 13057, United States
GSK Investigational Site
Endwell, New York, 13760, United States
GSK Investigational Site
Fishkill, New York, 12524, United States
GSK Investigational Site
New York, New York, 10016, United States
GSK Investigational Site
New York, New York, 10021, United States
GSK Investigational Site
Charlotte, North Carolina, 28207, United States
GSK Investigational Site
Raleigh, North Carolina, 27612, United States
GSK Investigational Site
Statesville, North Carolina, 28625, United States
GSK Investigational Site
Wilmington, North Carolina, 28401, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Cincinnati, Ohio, 45245, United States
GSK Investigational Site
Cincinnati, Ohio, 45246, United States
GSK Investigational Site
Cleveland, Ohio, 44195, United States
GSK Investigational Site
Kettering, Ohio, 45429, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73112, United States
GSK Investigational Site
Erie, Pennsylvania, 16508, United States
GSK Investigational Site
Warminster, Pennsylvania, 18974, United States
GSK Investigational Site
West Chester, Pennsylvania, 19380, United States
GSK Investigational Site
Columbia, South Carolina, 29201, United States
GSK Investigational Site
Greer, South Carolina, 29651, United States
GSK Investigational Site
Hartsville, South Carolina, 29550, United States
GSK Investigational Site
Simpsonville, South Carolina, 29681, United States
GSK Investigational Site
Bristol, Tennessee, 37620, United States
GSK Investigational Site
Kingsport, Tennessee, 37660, United States
GSK Investigational Site
Corpus Christi, Texas, 78404, United States
GSK Investigational Site
San Antonio, Texas, 78237, United States
GSK Investigational Site
San Antonio, Texas, 78258, United States
GSK Investigational Site
Salt Lake City, Utah, 84109, United States
GSK Investigational Site
Burke, Virginia, 22015, United States
GSK Investigational Site
Galax, Virginia, 24333, United States
GSK Investigational Site
Manassas, Virginia, 22015, United States
GSK Investigational Site
Newport News, Virginia, 23606, United States
GSK Investigational Site
Richmond, Virginia, 23294, United States
GSK Investigational Site
Springfield, Virginia, 22151, United States
GSK Investigational Site
Virginia Beach, Virginia, 23451, United States
GSK Investigational Site
Walla Walla, Washington, 99362, United States
GSK Investigational Site
Lewisburg, West Virginia, 24901, United States
GSK Investigational Site
Calgary, Alberta, T2E 7C5, Canada
GSK Investigational Site
Calgary, Alberta, T3C 3P1, Canada
GSK Investigational Site
Edmonton, Alberta, T5A 4L8, Canada
GSK Investigational Site
St. John's, Newfoundland and Labrador, A1E 2E2, Canada
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2, Canada
GSK Investigational Site
Brampton, Ontario, L6T 3T1, Canada
GSK Investigational Site
Greater Sudbury, Ontario, P3C 5K7, Canada
GSK Investigational Site
Greater Sudbury, Ontario, P3E 1H5, Canada
GSK Investigational Site
London, Ontario, N5W 6A2, Canada
GSK Investigational Site
Newmarket, Ontario, L3Y 5G8, Canada
GSK Investigational Site
Peterborough, Ontario, K9J 7B3, Canada
GSK Investigational Site
Sarnia, Ontario, N7T 4X3, Canada
GSK Investigational Site
Gatineau, Quebec, J8Y 6S8, Canada
GSK Investigational Site
Mirabel, Quebec, J7J 2K8, Canada
GSK Investigational Site
Trois-Rivières, Quebec, G8T 7A1, Canada
GSK Investigational Site
Ponce, 731, Puerto Rico
GSK Investigational Site
Rio Piedras, 00935, Puerto Rico
GSK Investigational Site
Río Grande, 00745, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2006
First Posted
January 9, 2006
Study Start
January 5, 2006
Primary Completion
December 1, 2007
Study Completion
December 28, 2007
Last Updated
June 25, 2018
Results First Posted
February 1, 2010
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.