Phase 3
Completed N=165
A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin
Source: ClinicalTrials.gov NCT00530946 ↗Enrolled (actual)
165
Serious AEs
0.0%
Results posted
Apr 2009
Primary outcomePrimary: Change in Systolic Blood Pressure — -16.6; -15.9; -21.8; -18.9 mm Hg
Summary
To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Systolic Blood Pressure |
-16.6; -15.9; -21.8; -18.9 | — |
| PRIMARY Percent Change in Low Density Lipoprotein-Cholesterol |
-37.2; -42.5; -34.3; -40.6 | — |
| SECONDARY Change in Systolic Blood Pressure From Baseline to Each Observation Point |
-12.8; -13.5; -19.2; -16.0; -14.2; -14.6 | — |
| SECONDARY Change in Diastolic Blood Pressure From Baseline to Each Observation Point |
-4.9; -6.0; -8.1; -8.2; -5.3; -8.2 | — |
| SECONDARY Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point |
-34.8; -42.5; -32.8; -40.2; -37.4; -43.8 | — |
| SECONDARY Percent Change in Total Cholesterol From Baseline to Each Observation Point |
-24.2; -30.5; -23.0; -28.3; -26.6; -31.5 | — |
| SECONDARY Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point |
7.7; 8.3; 6.6; 9.9; 7.2; 7.9 | — |
| SECONDARY Percent Change in Triglycerides From Baseline to Each Observation Point |
-15.1; -27.4; -16.2; -23.9; -14.2; -25.7 | — |
| SECONDARY Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point |
-1.2; -1.4; -1.1; -1.3; -1.3; -1.4 | — |
| SECONDARY Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point |
-1.3; -1.6; -1.2; -1.5; -1.4; -1.6 | — |
| SECONDARY Change in Apolipoprotein B From Baseline to Each Observation Point |
-36.6; -45.8; -33.5; -44.4; -40.1; -47.2 | — |
Eligibility Criteria
Inclusion Criteria
- The out-patient with concurrent hypertension and hyper-LDL-cholesterolemia is a male or female >=20 to =140 mmHg and =140 mg/dL and <250 mg/dL at Visit 3 (Week -2) and 4 (Week -1).
Exclusion Criteria
- Subjects who had experienced the following coronary artery disease within the past 3 months.
- Myocardial infarction
- Receiving PCI（percutaneous coronary intervention）or CABG (coronary artery bypass grafting)
- Any clinically meaningful valvular disease
- Subjects with a history of cerebrovascular diseases such as stroke or transient ischemic attack within the past 3 months.
Data sourced from ClinicalTrials.gov (NCT00530946). 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.