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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00123903
First received: July 22, 2005
Last updated: January 16, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Heart Failure, Congestive and Microalbuminuria
Drug: metoprolol xl
Drug: carvedilol MR
Drug: lisinopril
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in urine albumin: creatinine ratio (ACR) at six months of maintenance therapy. [ Time Frame: Baseline (Randomization Visit) and Month 6 ]

Secondary Outcome Measures:
  • Percentage of participants who achieved normoalbuminuria at 6 months of maintenance therapy. [ Time Frame: Month 6 ]
  • Percentage of participants who progressed to macroalbuminuria after 6 months of maintenance therapy. [ Time Frame: Month 6 ]
  • Change from baseline to month 6 LOCF in High-sensitivity C-reactive protein (hs-CRP) [ Time Frame: Baseline (Randomization Visit) and Month 6 ]
  • Change from Pre-screening visit to month 6 LOCF in urine ACR. [ Time Frame: Pre-screening Visit and Month 6 ]
  • 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) [ Time Frame: Baseline (Randomization visit) and Month 6 ]
  • Changes from baseline in blood pressure (systolic and diastolic) at month 6 of treatment. [ Time Frame: Baseline (Randomization Visit) and Month 6 ]
  • Changes from baseline in heart rate at month 6 of treatment. [ Time Frame: Baseline (Randomization visit) and Month 6 ]
  • Percentage of participants who required add-on therapy to reach target blood pressure at any time during the study. [ Time Frame: Up to 6 months ]
  • Number of participants with clinical chemistry parameters and hematology parameters of potential clinical concern at any time on-treatment. [ Time Frame: Up to 6 months ]
  • Number of participants with vital signs of potential clinical concern at any time on-treatment. [ Time Frame: Up to 6 months ]

Estimated Enrollment: 1220
Study Start Date: July 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: metoprolol xl Drug: carvedilol MR Drug: lisinopril
    Other Names:
    • carvedilol MR
    • metoprolol xl
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123903

  Show 94 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: COR103560
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: COR103560
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: COR103560
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: COR103560
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: COR103560
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: COR103560
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: COR103560
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00123903     History of Changes
Other Study ID Numbers: COR103560 
Study First Received: July 22, 2005
Last Updated: January 16, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
hypertension
urine albumin:creatinine ratio
microalbuminuria

Additional relevant MeSH terms:
Heart Failure
Hypertension
Albuminuria
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Lisinopril
Carvedilol
Metoprolol
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on January 24, 2017