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 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT00320060
Eligibility Criteria:
Inclusion Criteria:
* Males and Females (non-pregnant and non-lactating) between 18 and 70 years of age with type 1 or type 2 diabetes
* Sitting blood pressure of \<=170/100 mm Hg at weeks -2 and -1
* Hemoglobin A1C \<=12% at week -2
* Patients with diagnosis of diabetic nephropathy as defined by
1. Serum Creatinine \<=2.0 mg/dL at weeks -2 and -1
2. Urinary albumin excretion \>=300 mg/24 hours at week -2
3. Diagnosis of diabetic retinopathy
* Creatinine clearance \>=40 mL/min at weeks -2 and -1
* Voluntary written consent to participate in this study
Exclusion Criteria:
* History of allergic or adverse response to any B vitamin
* History of major cardiovascular or cerebrovascular events
* History of cancer except adequately treated basal or squamous cell carcinoma of the skin
* History of diabetic ketoacidosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00320060
Study Brief:
Protocol Section:
NCT00320060