Clinical trial NCT00273052: COREG MR Versus TOPROL-XL On The Lipid Profile Of Normolipidemic Or Mildly Dyslipidemic Patients With Hypertension
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: hypertension
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-01-09
Enrollment: 514
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Levels by Treatment Group at Maintenance Month 6
timeFrame: Baseline and Month 6
Secondary outcomes:
measure: Change From Baseline in Log Transformed High Sensitivity C-reactive Protein (Hs-CRP) by Treatment Group at Maintenance Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Log Transformed Lipoprotein-associated Phospholipase A2 (LpPLA2) by Treatment Group at Maintenance Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Blood Pressure by Treatment Group at Maintenance Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Heart Rate by Treatment Group at Maintenance Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Weight by Treatment Group at Maintenance Month
timeFrame: Baseline and Month 6
measure: Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of g/L at Maintenance Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Fasting Insulin (Glycemic Parameter) by Treatment Group at Maintenance Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Hemoglobin A1c (HbA1c) (Glycemic Parameter) by Treatment Group at Maintenance Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in c-Peptide (Glycemic Parameter) by Treatment Group at Maintenance Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Homeostasis Model Assessment (Glycemic Parameter) by Treatment Group at Maintenance Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Fasting Plasma Glucose (FPG) (Glycemic Parameter) by Treatment Group at Maintenance Month 6
timeFrame: Baseline and Month 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Montgomery
country: United States
facility: GSK Investigational Site
state: Alabama
city: Chandler
country: United States
facility: GSK Investigational Site
state: Arizona
city: Mesa
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
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facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Fayetteville
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Carmichael
country: United States
facility: GSK Investigational Site
state: California
city: Healdsburg
country: United States
facility: GSK Investigational Site
state: California
city: Irvine
country: United States
facility: GSK Investigational Site
state: California
city: La Jolla
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Mission Viejo
country: United States
facility: GSK Investigational Site
state: California
city: Poway
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Spring Valley
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facility: GSK Investigational Site
state: California
city: Stockton
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facility: GSK Investigational Site
state: California
city: Torrance
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facility: GSK Investigational Site
state: California
city: Vista
country: United States
facility: GSK Investigational Site
state: California
city: Avon
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facility: GSK Investigational Site
state: Connecticut
city: Altamonte Springs
country: United States
facility: GSK Investigational Site
state: Florida
city: Clearwater
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facility: GSK Investigational Site
state: Florida
city: Fort Lauderdale
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facility: GSK Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Jacksonville
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facility: GSK Investigational Site
state: Florida
city: Pembroke Pines
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facility: GSK Investigational Site
state: Florida
city: Atlanta
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facility: GSK Investigational Site
state: Georgia
city: Marietta
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facility: GSK Investigational Site
state: Georgia
city: Roswell
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facility: GSK Investigational Site
state: Georgia
city: Aurora
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state: Illinois
city: Chicago
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facility: GSK Investigational Site
state: Illinois
city: Gillespie
country: United States
facility: GSK Investigational Site
state: Illinois
city: Vernon Hills
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facility: GSK Investigational Site
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city: Evansville
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facility: GSK Investigational Site
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city: Indianapolis
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facility: GSK Investigational Site
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city: Wichita
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state: Kansas
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facility: GSK Investigational Site
state: Louisiana
city: Auburn
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facility: GSK Investigational Site
state: Maine
city: Natick
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facility: GSK Investigational Site
state: Massachusetts
city: Taunton
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facility: GSK Investigational Site
state: Massachusetts
city: West Yarmouth
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facility: GSK Investigational Site
state: Massachusetts
city: Detroit
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facility: GSK Investigational Site
state: Michigan
city: Brooklyn Center
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facility: GSK Investigational Site
state: Minnesota
city: Olive Branch
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facility: GSK Investigational Site
state: Mississippi
city: Saint Louis
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facility: GSK Investigational Site
state: Missouri
city: Springfield
country: United States
facility: GSK Investigational Site
state: Missouri
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Henderson
country: United States
facility: GSK Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Brick
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facility: GSK Investigational Site
state: New Jersey
city: Elizabeth
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Albuquerque
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facility: GSK Investigational Site
state: New Mexico
city: Albuquerque
country: United States
facility: GSK Investigational Site
state: New Mexico
city: East Syracuse
country: United States
facility: GSK Investigational Site
state: New York
city: Endwell
country: United States
facility: GSK Investigational Site
state: New York
city: Fishkill
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Statesville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cincinnati
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facility: GSK Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Kettering
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Warminster
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: West Chester
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Greer
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Hartsville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Simpsonville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Corpus Christi
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Burke
country: United States
facility: GSK Investigational Site
state: Virginia
city: Galax
country: United States
facility: GSK Investigational Site
state: Virginia
city: Manassas
country: United States
facility: GSK Investigational Site
state: Virginia
city: Newport News
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Springfield
country: United States
facility: GSK Investigational Site
state: Virginia
city: Virginia Beach
country: United States
facility: GSK Investigational Site
state: Virginia
city: Walla Walla
country: United States
facility: GSK Investigational Site
state: Washington
city: Lewisburg
country: United States
facility: GSK Investigational Site
state: West Virginia
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: St. John's
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Truro
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Newmarket
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Peterborough
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Gatineau
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Mirabel
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Trois Rivieres
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Ponce
country: Puerto Rico
facility: GSK Investigational Site
city: Rio Grande
country: Puerto Rico
facility: GSK Investigational Site
city: Rio Piedras
country: Puerto Rico
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: