Patients with Dyslipidemia and Hypertension
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with dyslipidemia and hypertension who take both 10mg of atorvastatin and 5mg of amlodipine
Exclusion criteria
Exclusion criteria: (1) Patients who have a history of stroke or AMI within 3 months (2) Patients with extremely unstable dyslipidemia or hypertension (3) Patients who are joining (or have joined within 3 months) other clinical trials (4) Patients who are taking drugs for dyslipidemia other than atorvastatin (5) Patients whose serum Triglyceride value exceeds 400 mg/dL (6) Patients with familial hyperlipidemia (7) Patients with secondary hyperlipidemia (8) Patients who are taking steroids (9) Patients who are suspected to have drug-induced muscle injury (10) Patients who have, suspected to have, or have a history of elective surgical therapy of malignancies within 3 years. (11) Patients whose serum CK value exceeds threefold of the upper normal limit (12) Patients who have contraindication to the statins or calcium-channel blockers, especially due to hypersensitivity or serious liver damage (13) Patients who are (suspected to be) pregnant (14) Patients who are considered unsuitable for the study by the responsible doctor for some reasonable causes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the difference of the serum LDL Cholesterol value between groups | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Rate and amount of change in serum LDL-Cho value (2) Quantitative analysis of drug adherence using Japanese edition of MMAS-8 questionnaire (3) Rate and amount of change among other lipid profiles such as HDL-Cho, T-Cho, and TG (4) Rate of achievement in the treatment goal according to the Japanese guideline for the prevention of atherosclerosis (5) Rate and amount of change in office blood pressures (6) Subanalyses as to sex, age, BMI, serum LDL value on baseline, number of tablets taken, and use of narcotics (7) Effect of the change in pattern to take drugs on serum lipid profiles | — |
Countries
Japan
Contacts
Chiba University Graduate School of Medicine Department of Cardiovascular Medicine