Phase 3
Completed N=568
COREG MR Versus TOPROL-XL On The Lipid Profile Of Normolipidemic Or Mildly Dyslipidemic Patients With Hypertension
Source: ClinicalTrials.gov NCT00273052 ↗Enrolled (actual)
568
Serious AEs
—
Results posted
Feb 2010
Primary outcomePrimary: Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance Month 6 — 2.65; 10.39 mg/dL — p=0.0141
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance Month 6 |
2.65; 10.39 | 0.0141 sig |
| PRIMARY Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Levels by Treatment Group at Maintenance Month 6 |
-4.4; -5.1 | 0.6068 |
| SECONDARY Change From Baseline in Log Transformed High Sensitivity C-reactive Protein (Hs-CRP) by Treatment Group at Maintenance Month 6 |
-1.76; 0.49 | — |
| SECONDARY Change From Baseline in Log Transformed Lipoprotein-associated Phospholipase A2 (LpPLA2) by Treatment Group at Maintenance Month 6 |
-2.38; -2.23 | — |
| SECONDARY Change From Baseline in Blood Pressure by Treatment Group at Maintenance Month 6 |
-15.90; -16.23; -10.89; -11.06 | — |
| SECONDARY Change From Baseline in Heart Rate by Treatment Group at Maintenance Month 6 |
-5.98; -6.07 | — |
| SECONDARY Change From Baseline in Weight by Treatment Group at Maintenance Month |
1.01; 0.73 | — |
| SECONDARY Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6 |
0.1; -0.7; -1.1; -1.7; 0.9; 0.4 | — |
| SECONDARY Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of g/L at Maintenance Month 6 |
-1.82; -3.45; -1.16; 0.81 | — |
| SECONDARY Change From Baseline in Fasting Insulin (Glycemic Parameter) by Treatment Group at Maintenance Month 6 |
-1.21; 1.35 | — |
| SECONDARY Change From Baseline in Hemoglobin A1c (HbA1c) (Glycemic Parameter) by Treatment Group at Maintenance Month 6 |
0.01; 0.04 | — |
| SECONDARY Change From Baseline in c-Peptide (Glycemic Parameter) by Treatment Group at Maintenance Month 6 |
-0.23; 0.20 | — |
| SECONDARY Change From Baseline in Homeostasis Model Assessment (Glycemic Parameter) by Treatment Group at Maintenance Month 6 |
2.05; -4.14 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) (Glycemic Parameter) by Treatment Group at Maintenance Month 6 |
0.94; 1.20 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00273052). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.