Comparison Of Morning And Evening Dosing Of Valsartan And Lisinopril In Patients With Diabetes
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A Randomized, Double Blind, Double Dummy, Parallel Group, Active-Controlled Study To Evaluate The Effectiveness Of Morning Versus Evening Doses Of 320 Mg Valsartan Versus 40 Mg Lisinopril On The 24 Hour Blood Pressure Profile In Patients With Hypertension And Non-Insulin Dependent Diabetes
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
65 Years and older (Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
- Hypertension defined by a MSSBP >=150 mmHg (untreated patients) or patients on current anti-hypertensive treatment who remain uncontrolled (i.e. MSSBP >140 mmHg)
Randomisation mean 24h blood pressure above 130/80 mmHg
In addition the patients must fulfill, at least, one of the following criteria:
Controlled type II Diabetes mellitus Hypercholesteremia, currently treated with lipid-lowering drugs Metabolic syndrome MI, CABG or PTCA more than one year ago Stroke or transient ischemic cerebral attack more than one year ago Documented history of peripheral vascular disease, increased IMT, or carotid plaques Documented history of LVH Elderly >65 years
- MSSBP >=180 mmHg and/or MSDBP >= 110 mmHg at any time from Visit 1 to Visit 3
Inability to discontinue all prior anti-hypertensive medications safely for a period of three weeks
Mandatory indication for any concomitant medication for coronary artery disease or any other disease that is not allowed during this study.
Other protocol-defined exclusion criteria may apply.