Type 2 diabetes complicated with hypertention and hypercholestrolemia
Conditions
Interventions
Switching to amlodipine / atorvastatin combination drug.
Sponsors
Kanazawa Medical University Diabetes and Endocrinology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Outpatient 2) Patients receiving the treatment with amlodipine besilate for more than 3 months,at the time of registration. 3) Patients whose serum LDL-C levels are more than 120mg/dl,regardless with or without medication for hypercholesterolemia,at the time of registration. 4) Patients who can obtain voluntary conset documents for participation in this study,after a sufficient informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients whose systolic blood pressure is more than 180mmHg and diastolic blood pressure is more than 110mmHg and whose blood pressure are not well-controlled and considered to add or increase the dose of hypertensive drugs druing this study. 2) Secondry hypertention patiebs. 3) Familial hypercholesterolemia patients. 4) Patients with secondary prevention who developed cardiovascular events,such as acute myocardial infarction and cerebral infarction in the past. 5) Patients with severe heart failure patients. 6) Patients with severe arrhythmias. 7) eGFR is less than 40ml/min/1.73 square meters. 8) Patients with advanced liver failure. 9) Patients with active malignancy. 10)Patients during administration of immunosuppressants or steroid. 11) Women who are pregnant or possibly pregnant or wish to pregnant or lactating. 12)Patients with allergy or contraindication to test drug. 13) Intellectually or mentally disabled patients who are impossible to agree or with suspected ability to agree. 14) Patients judged not suitable by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)The amount of change in serum LDL-C levels between at baseline and after 6 months. 2)The amount of change in systolic blood pressure between at baseline and after 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)The amount of change in serum LDL-C levels between at baseline and after 12 months. 2)The amount of change in systolic blood pressure between at baseline and after 12 months. 3)Achievement rate of lipid management goal of after 6 and 12 months. 4)The amount of change in the follwing items between at the baseline and 6 months or 12 months. Diastolic blood pressure. 8-iso-PGF2 concentration in blood The amount of change in oxidized LDL Fasting blood glucose level The amount of change in HbA1c Cystatin-C concentration Urinary albumin / creatinine ratio eGFR Blood adiponectin concentration 5)The amount of change in carotid IMT between at baseline and 6 or 12 months. 6)Adverse events. | — |
Countries
Japan
Contacts
Public ContactMunehiro Kitada
Kanazawa Medical University Diabetes and Endocrinology
Outcome results
None listed