The study for the efficacy of amlodipine/atorvastatin combination drug in patients with type 2 diabetes complicated with hypertention and hypercholestrolemia.

Not Applicable

• Conditions: Type 2 diabetes complicated with hypertention and hypercholestrolemia

• Registration Number: JPRN-UMIN000010895
• Lead Sponsor: Kanazawa Medical University Diabetes and Endocrinology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.