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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Carvedilol Phosphate modified release formulation (Drug); metoprolol succinate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance Month 6

Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Levels by Treatment Group at Maintenance Month 6

Secondary outcome:

Change From Baseline in Log Transformed High Sensitivity C-reactive Protein (Hs-CRP) by Treatment Group at Maintenance Month 6

Change From Baseline in Log Transformed Lipoprotein-associated Phospholipase A2 (LpPLA2) by Treatment Group at Maintenance Month 6

Change From Baseline in Blood Pressure by Treatment Group at Maintenance Month 6

Change From Baseline in Heart Rate by Treatment Group at Maintenance Month 6

Change From Baseline in Weight by Treatment Group at Maintenance Month

Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6

Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of g/L at Maintenance Month 6

Change From Baseline in Fasting Insulin (Glycemic Parameter) by Treatment Group at Maintenance Month 6

Change From Baseline in Hemoglobin A1c (HbA1c) (Glycemic Parameter) by Treatment Group at Maintenance Month 6

Change From Baseline in c-Peptide (Glycemic Parameter) by Treatment Group at Maintenance Month 6

Change From Baseline in Homeostasis Model Assessment (Glycemic Parameter) by Treatment Group at Maintenance Month 6

Change From Baseline in Fasting Plasma Glucose (FPG) (Glycemic Parameter) by Treatment Group at Maintenance Month 6

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: January 2006
Last updated: July 11, 2013

Page last updated: August 23, 2015

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