A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk
Summary
The purpose of this study is to investigate whether an aggressive multi-risk factor management strategy (Caduet plus therapeutic lifestyle changes (TLC) regimen) will result in greater percentage of patients achieving blood pressure and low density lipoprotein cholesterol (LDL-C) goals compared with a Joint National Committee 7/ National Cholesterol Education Program Adult Treatment Panel III (JNC 7/NCEP ATP III) guideline-based approach (Norvasc plus TLC regimen) after 6 weeks of treatment in primary prevention subjects with hypertension and additional risk factors, including dyslipidemia.
Timeline
- Start
- 2007-01
- Primary completion
- 2008-04
- Completion
- 2008-04
Outcome
Met primary endpoint
registry NUMBER Norvasc + TLC: 11 participants NUMBER Caduet + TLC: 80 participants NCT00412113 ↗
registry analysis (unspecified test); Norvasc + TLC vs Caduet + TLC; p <0.001; Odds Ratio (OR) 19.03 (95% CI 9.14 to 39.63) NCT00412113 ↗
registry LEAST_SQUARES_MEAN Norvasc + TLC: -0.1 (Standard Deviation 2.9) score on scale LEAST_SQUARES_MEAN Caduet + TLC: -2.9 (Standard Deviation 3.0) score on scale NCT00412113 ↗
registry analysis (unspecified test); Norvasc + TLC vs Caduet + TLC; p <0.001; Difference in LS Means -2.8 (95% CI -3.5 to -2.1); ANCOVA NCT00412113 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amlodipine | Other / unclassified | 5 mg | — |
| Subject | Amlodipine | Other / unclassified | 10 mg | — |
| Subject | Atorvastatin | Small molecule | 20 mg | — |