Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT01252056
Eligibility Criteria:
Inclusion Criteria:
* Male or female age 40\~75 years old
* Type 2 diabetes mellitus above 6 months
* HbA1c ≤8%
* Twice (above 2-week interval) confirmed urinary albumin at 30-3000µg/mg.cre
* Receive routine dosage ACEI or ARB treatment above 2 months, and the dosage has been fixed for at least 1 month
* LDL-C\>100 mg/dL (2.60 mmol/L) and/ or hyperlipidemia patients with Statins treatment
* Free will to sign the informed consent form
Exclusion Criteria:
* Has an allergic history to investigational drugs
* Receive antilipemic agents (except Statins) within the latest 2 months, including Probucol
* Receive antiplatelet or anticoagulation agents (except Aspirin) within the latest 2 months, including Cilostazol
* Rapid progression of nephropathy within the latest 3 months
* Kidney disease caused by other reasons according to medical history
* Serum potassium level less than 3.5 mEq/L or more than 5.5 mEq/L
* Hemorrhagic tendency or hemorrhagic disease (such as alimentary tract hemorrhage, active fundus hemorrhage, etc.)
* Has a myocardial infarction, angina pectoris, or cerebral infarction within the latest 3 months
* Congestive heart failure
* Pregnant, potentially pregnant, or lactating woman
* Severe hepatic inadequacy (AST or ALT is 2.5 times higher than the upper limit of the normal value range)
* Serum creatinine level is 1.5 times higher than the upper limit of the normal value range
* Persistent or hardly controlled hypertension (such as malignant hypertension, SBP≥170 mmHg and/ or DBP≥100 mmHg)
* Severe ventricular arrhythmia (such as multiple and multifocal premature ventricular contractions)
* Has a medical history of cardiac syncope or primary syncope
* Has condition that may prolong QT interval (such as congenital long QT syndrome, taking drugs which prolong QT interval, hypokalemia or hypomagnesemia, etc.), or for man QT interval\>450msec, for woman QT interval\>470msec
* Has severe complication (such as diabetes mellitus ketoacidosis, nonketotic hyperosmolar diabetic coma, malignant tumor, severe anaemia, severe hematologic diseases, etc.)
* Register other clinical trials within the latest 3 months
* Other conditions that would be excluded from this study according to doctors'judgment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT01252056
Study Brief:
Protocol Section:
NCT01252056