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

NCT ID: NCT00273052

Last Updated: 2018-06-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

514 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-05

Study Completion Date

2007-12-28

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Carvedilol Phosphate modified release formulation

Group Type EXPERIMENTAL

Carvedilol Phosphate modified release formulation

Intervention Type DRUG

metoprolol succinate

Group Type ACTIVE_COMPARATOR

metoprolol succinate

Intervention Type DRUG

Interventions

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Carvedilol Phosphate modified release formulation

Intervention Type DRUG

metoprolol succinate

Intervention Type DRUG

Other Intervention Names

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Carvedilol Phosphate modified release formulation

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Montgomery, Alabama, United States

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Chandler, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Fayetteville, Arkansas, United States

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Little Rock, Arkansas, United States

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Carmichael, California, United States

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Healdsburg, California, United States

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Irvine, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Mission Viejo, California, United States

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Poway, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Spring Valley, California, United States

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Stockton, California, United States

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Torrance, California, United States

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Vista, California, United States

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Avon, Connecticut, United States

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Altamonte Springs, Florida, United States

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Clearwater, Florida, United States

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Fort Lauderdale, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Pembroke Pines, Florida, United States

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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Roswell, Georgia, United States

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Aurora, Illinois, United States

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Chicago, Illinois, United States

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Gillespie, Illinois, United States

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Vernon Hills, Illinois, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Wichita, Kansas, United States

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Wichita, Kansas, United States

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Bossier City, Louisiana, United States

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Auburn, Maine, United States

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Natick, Massachusetts, United States

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Taunton, Massachusetts, United States

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West Yarmouth, Massachusetts, United States

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Detroit, Michigan, United States

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Brooklyn Center, Minnesota, United States

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Olive Branch, Mississippi, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Brick, New Jersey, United States

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Elizabeth, New Jersey, United States

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Albuquerque, New Mexico, United States

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Albuquerque, New Mexico, United States

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East Syracuse, New York, United States

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Endwell, New York, United States

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Fishkill, New York, United States

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New York, New York, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, United States

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Statesville, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Kettering, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Erie, Pennsylvania, United States

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Warminster, Pennsylvania, United States

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West Chester, Pennsylvania, United States

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Columbia, South Carolina, United States

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Greer, South Carolina, United States

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Hartsville, South Carolina, United States

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Simpsonville, South Carolina, United States

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Bristol, Tennessee, United States

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Kingsport, Tennessee, United States

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Corpus Christi, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Burke, Virginia, United States

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Galax, Virginia, United States

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Manassas, Virginia, United States

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Newport News, Virginia, United States

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Richmond, Virginia, United States

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Springfield, Virginia, United States

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Virginia Beach, Virginia, United States

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Walla Walla, Washington, United States

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Lewisburg, West Virginia, United States

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Calgary, Alberta, Canada

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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St. John's, Newfoundland and Labrador, Canada

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Truro, Nova Scotia, Canada

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Brampton, Ontario, Canada

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Greater Sudbury, Ontario, Canada

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Greater Sudbury, Ontario, Canada

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London, Ontario, Canada

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Newmarket, Ontario, Canada

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Peterborough, Ontario, Canada

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Sarnia, Ontario, Canada

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Gatineau, Quebec, Canada

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Mirabel, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Ponce, , Puerto Rico

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Rio Piedras, , Puerto Rico

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Río Grande, , Puerto Rico

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Countries

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United States Canada Puerto Rico

Study Documents

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Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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COR103561

Identifier Type: -

Identifier Source: org_study_id

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