Last updated: 11/04/2018 05:58:08

COREG MR Versus TOPROL-XL On Reduction Of Microalbuminuria In Patients With Hypertension And Microalbuminuria

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GSK study ID
COR103560
See study documents
Clinicaltrials.gov ID
NCT00123903
See results summary
EudraCT ID
2006-000034-12
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Change from baseline in urine albumin: creatinine ratio (ACR) at six months of maintenance therapy

Timeframe: Baseline (Randomization Visit) and Month 6

Secondary outcomes:

Percentage of par who achieved normoalbuminuria at 6 months of maintenance therapy

Timeframe: Month 6

Percentage of par who progressed to macroalbuminuria after 6 months of maintenance therapy

Timeframe: Month 6 to Month 7

Change from baseline to month 6 LOCF in High-sensitivity C-reactive protein (hs-CRP)

Timeframe: Baseline (Randomization Visit) and Month 6

Change from Pre-screening visit to month 6 LOCF in urine ACR

Timeframe: Pre-screening Visit and Month 6

Change from Baseline visit to month 6 (LOCF) in lipids including total cholesterol, low density lipid, high density lipid and Triglycerides

Timeframe: Baseline (Randomization visit) and Month 6

Percentage of par with occurrence of new onset diabetes mellitus at month 6 LOCF

Timeframe: Baseline (Randomization visit) and Month 6

Changes from baseline in blood pressure (systolic and diastolic) at month 6 of treatment

Timeframe: Baseline (Randomization Visit) and Month 6

Changes from baseline in heart rate at month 6 of treatment

Timeframe: Baseline (Randomization visit) and Month 6

Percentage of par who required add-on therapy to reach target blood pressure at any time during the study

Timeframe: Up to 6 months

Number of par with clinical chemistry parameters and hematology parameters of potential clinical concern (PCC) at any time on-treatment

Timeframe: Up to 6 months

Number of par with vital signs of PCC at any time on-treatment

Timeframe: Up to 6 months

Interventions:
  • Drug: metoprolol xl
  • Drug: carvedilol MR
  • Drug: lisinopril
    • Enrollment:
    107
    Primary completion date:
    2006-09-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Heart failure, Congestive and Microalbuminuria
    Product
    carvedilol
    Collaborators
    Not applicable
    Study date(s)
    July 2005 to May 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 80 years
    Accepts healthy volunteers
    No
    • 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.
    • 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.
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    London, Ontario, Canada, N5W 6A2
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19152
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Toronto, Ontario, Canada, M9W 4L6
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75231
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Houston, Texas, United States, 77024
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Evansville, Indiana, United States, 47714
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 94 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Other
    Actual primary completion date
    2006-09-05
    Actual study completion date
    2006-09-05

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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