Status:
COMPLETED
Anti-Inflammatory Actions of Valsartan in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
University of Ulm
Conditions:
Hypertension
Type 2 Diabetes Mellitus
Eligibility:
All Genders
30-80 years
Phase:
PHASE4
Brief Summary
This study is designed to support the use of valsartan in the diabetic population. Two different groups will be studied, one with and one without coronary artery disease (CAD) documented by angiograph...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00982358
Start Date
July 1 2004
End Date
March 1 2007
Last Update
September 23 2009
Active Locations (2)
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1
University of Ulm, Department of Internal Medicine II
Ulm, Baden-Wurttemberg, Germany, 89081
2
Charité University Medicine Berlin, Center for Cardiovascular Research, Outpatient Clinic
Berlin, State of Berlin, Germany, 10115