Concurrent hypertension (ICD code 80011/MedDRA: coded under preferred term "vascular system order", code 10020772) and dyslipidaemia (ICD code 89212/MedDRA: coded under preferred term "metabolism and nutrition disorder", code 10058108).
Conditions
Interventions
Pharmaceutical Form:
INN or Proposed INN: atorvastatin calcium
Concentration unit: mg milligram(s)
Concentration number: 10-
INN or Proposed INN: amlodipine besilate
Concentration unit: mg milligram
Sponsors
Pfizer Healthcare Ireland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Treated or untreated subjects diagnosed with concurrent hypertension and dyslipidaemia, qualifying for drug treatment according to the governing guidelines. • The BP level to be used for eligibility assessment will be the average of the levels obtained at the qualifying visits. Blood pressure must be not at target as defined by governing guidelines. • The LDL-C level to be used for eligibility assessment is a single value obtained at screening. LDL-C may be at target on medication or not at target with or without medication as defined by governing guidelines. • For subjects receiving dyslipidaemia and/or antihypertensive therapy at screening, the doses of medication must be stable for at least 6 weeks prior to baseline assessments. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Subjects whose BP is adequately maintained at target with or without medication; • Subjects who are currently treated with both amlodipine and atorvastatin; • Subjects who are being treated with amlodipine 10 mg or other maximum dose calcium channel blockade therapy, or have a serum LDL-C concentration = 2.5mmol/L(100 mg/dL) while being treated with atorvastatin 80 mg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of amlodipine/atorvastatin therapy by assessing the percentage of subjects who reach target blood pressure (BP) and lowdensity lipoprotein cholesterol (LDL-C) targets as defined by their governing guidelines.;Secondary Objective: To assess changes from baseline to end of treatment for the following efficacy parameters: • LDL-C, total cholesterol (TC), triglycerides, high-density lipoprotein cholesterol (HDL-C), HDL-C/LDL-C ratio, TC/HDL-C ratio. • Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP). To evaluate the safety of amlodipine/atorvastatin with titration of amlodipine and atorvastatin doses sufficient to reach BP and LDL-C therapeutic targets. To validate a newly developed questionnaire, the Expectations and Satisfaction with Treatment Questionnaire (ESTQ). For all primary and secondary efficacy parameters (except ESTQ), the following factors are also of interest: • Presence/absence of prior antihypertensive therapy • Presence/absence of prior lipid lowering therapy • Primary/secondary prevention of CVD • Presence/absence of diabetes ;Primary end point(s): The primary efficacy variable is the percentage of subjects achieving both blood pressure and lipid treatment targets as defined by governing guidelines. | — |
Countries
Austria, Hungary, Ireland, Italy, Spain
Outcome results
None listed