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:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT00202618
Eligibility Criteria:
Inclusion Criteria:
* Hypertensive patient with type 2 diabetes
* Microalbuminuria defined as a urinary albumin excretion of 30 to 300 mg/gCr
Exclusion Criteria:
* Type 1 diabetes mellitus
* Pregnant women and women of childbearing potential
* Severe hypertension (\> 180/110 mmHg), malignant hypertension, secondary hypertension
* History of cardiovascular diseases in the preceding 6 months (including symptomatic heart failure, unstable angina, myocardial infarction, the performance of percutaneous transluminal coronary angioplasty \[PTCA\], or coronary artery bypass graft \[CABG\], severe arrhythmia, or second or third degree atrioventricular \[AV\] block)
* History of clinically significant valvular disease (e.g., aortic stenosis, mitral insufficiency)
* History of cerebral infarction, cerebral hemorrhage, or transient ischemic attack
* Serum creatinine level \>1.5 mg/dl
* Persistent hematuria
* Serum potassium \> 5.6 mEq/L (hyperkalemia)
* Severe hepatic disorder (e.g., hepatic failure, hepatic cirrhosis)
* Complication of an allergy of potential clinical concern
* Hypersensitivity to ARBs or CCBs
* Gastrointestinal surgery or gastrointestinal disorders which could interfere with drug absorption
* Autoimmune disease
* Participation in any intervention trial within 3 months prior to the observation period
* Patients who are unwilling or unable to comply with the trial protocol
* Concomitant use of other ARBs, CCBs, or potassium-retaining diuretics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT00202618
Study Brief:
Protocol Section:
NCT00202618