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 @ 1:32 PM
Ignite Modification Date:
2025-12-24 @ 1:32 PM
NCT ID:
NCT00550095
Eligibility Criteria:
Inclusion Criteria:
* Males or females aged 35 to 75.
* Type 2 diabetes mellitus (DM) patients coupled with hypertension \[sitting systolic blood pressure (SSBP) 140-179 mm Hg and/or SDBP 90-109 mm Hg\].
* Urinary albumin creatinine Ratio (UACR)) indicating microalbuminuria/proteinuria \[30-1000 mg/g or 2.5-25 mg/mmol\]
* Body mass index (BMI) \<40 kg/m2
* Patients who will sign an informed consent.
Exclusion Criteria
* Type 1 DM
* All causes of secondary diabetes mellitus
* Women of childbearing potential who refuse to use contraception.
* Pregnant or lactating females.
* Severe hypertension \[SSBP\> 180 mmHg, sitting diastolic blood pressure (SDBP) \> 110 mmHg \]
* Patients who are on combo therapy to control BP
* Patients who are already on Valsartan.
* Hypersensitivity to Valsartan.
* Renal artery stenosis \[ unilateral or bilateral\]
* Patients taking β blockers, (Angiotensin Converting Enzyme Inhibitor (ACEI) or spironolactone
* Heart Failure
* History of myocardial infarction, Percutaneous Transluminal Coronary Angioplasty(PTCA) or cerebrovascular accident within the preceding 3 months.
* Creatinine levels \> 1.4 mg/dl \[ 0.07mmol/l\]. Liver enzymes \> 2 times Upper Limit of the Normal Range(ULN). Diabetic keto-acidosis (DKA) within the last 6 months. Presence of diabetic neuropathy or retinopathy. Diabetic foot complications. Presence of infection at time of screening. Hyperkalemia (serum K+ \> 5.5 mmol/L)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT00550095
Study Brief:
Protocol Section:
NCT00550095