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 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
NCT ID:
NCT00065559
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or greater
* Men or non-pregnant, non-lactating women with Type 1 or Type II diabetes and renal disease
* 24-hour urinary protein excretion greater than or equal to 500 mg
* Serum creatinine less than or equal to 3 mg/dl
* Willingness and ability to give informed consent and to cooperate with the protocol including discontinuing current antihypertensive medications if necessary
Exclusion Criteria:
* Pregnant or lactating women
* Renal disease other than diabetic nephropathy
* Renal Transplant or on dialysis
* Immunosuppressive agents for greater than 2 weeks in the 3 months prior to randomization (inhaled steroids are permissible)
* Renal vascular disease (uncorrected and hemodynamically significant)
* Obstructive uropathy (uncorrected and hemodynamically significant)
* History or evidence of acute renal failure within 6 months prior to randomization visit
* Serum potassium greater than 5.2 mEq/L
* Known human immunodeficiency virus disease (HIV)
* Any major disorder which in the opinion of the investigator would reduce life expectancy during the course of this study or could preclude participation in this or could adversely effect the interpretation of the data.
* Anticipated inability to cooperate with or any condition of sufficient severity to impair participation in the study.
* Any of the following cardiovascular conditions within 1 month of the screening visit: myocardial infarction, coronary angioplasty, coronary artery bypass graft, other revascularization procedure, severe or unstable angina, stroke, transient ischemic attack or hemodynamically important vascular disease.
* Need for chronic (greater than 2 weeks) immunosuppressive therapy including oral or IV corticosteroids. (Inhaled steroids are permissible.)
* History of drug sensitivity or adverse reaction to both ACE I and ARB.
* History of drug sensitivity, allergy, or adverse reaction to COX-2 inhibitor, aspirin, or sulfonamides.
* Evidence or suspicion of drug abuse or excessive alcohol consumption within 12 months prior to screening visit 1.
* Receipt of any investigational drug within 30 days or 5 half-lives of the investigational drug (the longer period will apply) before screening visit 1.
* Active psychiatric disorder.
* History of peptic ulcer disease and/or gastrointestinal bleeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00065559
Study Brief:
Protocol Section:
NCT00065559