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This study evaluates the anti-inflammatory effects of the blood pressure drug Valsartan, compared with placebo, in patients with type 2 diabetes mellitus. It enrolled patients aged 30-80 with controlled type 2 diabetes and stage 1 hypertension. The study was conducted in Phase 4 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Male or female patients between 30 and 80 years old, inclusive * Controlled type 2 Diabetes Mellitus on stable treatment at least during the 4 weeks prior to visit 1 * Treated or untreated stage 1 (according to JNC VII Guidelines) or grade 1 (according to ESH/ESC 2003 Guidelines) hypertensive patients * For one stratum: angiographically proven CAD * Signed informed consent prior to any study procedure Exclusion Criteria: * Hypertension classified as stage 2 (or grade 2) or higher * Normotensive patients, i.e. patients who do not have a history of high blood pressure, and who are not receiving any antihypertensive medication * Treatment with more than 2 antihypertensive medications * Current treatment with ARBs * Glycated hemoglobin (HbA1c) \>8.5% at Visit 1 * Current treatment with glitazones * Myocardial infarction less than 3 months prior to Visit 1 * Total cholesterol \>7.8 mmol/l * Past diagnosis of any systemic inflammatory disease * Known or suspected contraindications, including history of allergy to angiotensin receptor blockers * History of hypertensive encephalopathy or cerebrovascular accident less than 1 year prior to Visit 1 * Known Keith-Wagener grade III or IV hypertensive retinopathy * History of heart failure * Second or third degree heart block without a pacemaker * Concomitant unstable angina pectoris * Concurrent potential life threatening arrhythmia or symptomatic arrhythmia * Clinically significant valvular heart disease * Evidence of hepatic disease as determined by any one of the following: ALT or AST values \> 2 x ULN at Visit 1, a history hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt * Evidence of renal impairment as determined by any one of the following: serum creatinine \>1.25 x ULN at visit 1, a history of dialysis, or a history of nephritic syndrome * Sodium value \<132 mmol/L at Visit 1 * Serum potassium values \<3.5 mmol/L or \>5.5 mmol/L at visit 1 * Any surgical or medical condition which might alter the absorption, distribution, metabolism, excretion of any drug * Female patients who are not either post-menopausal for one year of surgically sterile, and who are not using effective contraceptive methods such as barrier method with spermicidal or an intra-uterine device. Oral contraceptive use or dermal implants as the only means of contraception are disallowed * Pregnant or lactating females * Any surgical or medical condition which, at the discretion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patients from complying with the requirements of the study or completing the trial period * History of malignancy including leukemia and lymphoma within 5 years prior to Visit 1 * History of any severe, life threatening disease within the past five years * Any previous history of a systemic autoimmune disease * History of drug or alcohol abuse within the last two years * Participation in any investigational drug trial within one month prior to visit 1