Clinical trial NCT00123903: COREG MR Versus TOPROL-XL On Reduction Of Microalbuminuria In Patients With Hypertension And Microalbuminuria
Official title: A Randomized, Double-blind, Positive-Controlled, Multicenter Study Comparing the Efficacy of Carvedilol Phosphate Modified Release Formulation (COREG MR) and Metoprolol Succinate Extended Release (TOPROL-XL) on the Reduction of Microalbuminuria in Patients With Hypertension and Microalbuminuria
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Heart Failure, Congestive and Microalbuminuria
Keywords: hypertension
urine albumin:creatinine ratio
microalbuminuria
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-07-26
Enrollment: 1220
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 COREG MR is more effective than TOPROL-XL in reducing microalbuminuria in type 2 diabetic or non-diabetic patients with high blood pressure and microalbuminuria.


Eligibility criteria: Inclusion criteria:

* Documented history of hypertension.
* Must have been taking an ACE (angiotensin converting enzyme) inhibitor either alone or as part of an antihypertensive regimen for at least 8 weeks.
* Persistent microalbuminuria.

Exclusion criteria:

* History of heart attack, stroke, congestive heart failure, arrhythmia, type 1 or uncontrolled type 2 diabetes mellitus, liver or renal disease.
* Has been taking any non-ocular beta-blockers for any indication within three months prior to Pre-screening.

Primary outcomes:
measure: Change from baseline in urine albumin: creatinine ratio (ACR) at six months of maintenance therapy.
timeFrame: Baseline (Randomization Visit) and Month 6
Secondary outcomes:
measure: Percentage of participants who achieved normoalbuminuria at 6 months of maintenance therapy.
timeFrame: Month 6
measure: Percentage of participants who progressed to macroalbuminuria after 6 months of maintenance therapy.
timeFrame: Month 6
measure: Change from baseline to month 6 LOCF in High-sensitivity C-reactive protein (hs-CRP)
timeFrame: Baseline (Randomization Visit) and Month 6
measure: Change from Pre-screening visit to month 6 LOCF in urine ACR.
timeFrame: Pre-screening Visit and Month 6
measure: Change from baseline to visit to month 6 LOCF in lipids including total cholesterol, low density lipid (LDL), high density lipid (HDL) and Triglycerides (TG)
timeFrame: Baseline (Randomization visit) and Month 6
measure: Changes from baseline in blood pressure (systolic and diastolic) at month 6 of treatment.
timeFrame: Baseline (Randomization Visit) and Month 6
measure: Changes from baseline in heart rate at month 6 of treatment.
timeFrame: Baseline (Randomization visit) and Month 6
measure: Percentage of participants who required add-on therapy to reach target blood pressure at any time during the study.
timeFrame: Up to 6 months
measure: Number of participants with clinical chemistry parameters and hematology parameters of potential clinical concern at any time on-treatment.
timeFrame: Up to 6 months
measure: Number of participants with vital signs of potential clinical concern at any time on-treatment.
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Mobile
country: United States
facility: GSK Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Fullerton
country: United States
facility: GSK Investigational Site
state: California
city: Inglewood
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: Oakland
country: United States
facility: GSK Investigational Site
state: California
city: Redondo Beach
country: United States
facility: GSK Investigational Site
state: California
city: Colorado Springs
country: United States
facility: GSK Investigational Site
state: Colorado
city: Hollywood
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: GSK Investigational Site
state: Florida
city: Sarasota
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Decatur
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Melrose Park
country: United States
facility: GSK Investigational Site
state: Illinois
city: Avon
country: United States
facility: GSK Investigational Site
state: Indiana
city: Elkhart
country: United States
facility: GSK Investigational Site
state: Indiana
city: Evansville
country: United States
facility: GSK Investigational Site
state: Indiana
city: Evansville
country: United States
facility: GSK Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Lafayette
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Ayer
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Worcester
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Voorhees
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Buffalo
country: United States
facility: GSK Investigational Site
state: New York
city: Camillus
country: United States
facility: GSK Investigational Site
state: New York
city: East Syracuse
country: United States
facility: GSK Investigational Site
state: New York
city: Kingston
country: United States
facility: GSK Investigational Site
state: New York
city: Port Chester
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Columbus
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: Oregon City
country: United States
facility: GSK Investigational Site
state: Oregon
city: Beaver
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Havertown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Reading
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: West Grove
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: East Providence
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Greer
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Orangeburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Johnson City
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Beaumont
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
city: Galveston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Midland
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: Burke
country: United States
facility: GSK Investigational Site
state: Virginia
city: Springfield
country: United States
facility: GSK Investigational Site
state: Virginia
city: Edmonds
country: United States
facility: GSK Investigational Site
state: Washington
city: Olympia
country: United States
facility: GSK Investigational Site
state: Washington
city: Spokane
country: United States
facility: GSK Investigational Site
state: Washington
city: Spokane
country: United States
facility: GSK Investigational Site
state: Washington
city: Spokane
country: United States
facility: GSK Investigational Site
state: Washington
city: Wenatchee
country: United States
facility: GSK Investigational Site
state: Washington
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: New Westminster
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Bay Roberts
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Kitchener
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Stoney Creek
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Charlottetown
country: Canada
facility: GSK Investigational Site
state: Prince Edward Island
city: Montague
country: Canada
facility: GSK Investigational Site
state: Prince Edward Island
city: Bonaventure
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Mirabel
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Saint-Romuald
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Trois Rivieres
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Rio Grande
country: Puerto Rico
facility: GSK Investigational Site
city: San Juan
country: Puerto Rico
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: