Status:
COMPLETED
Comparison Of Morning And Evening Dosing Of Valsartan And Lisinopril In Patients With Diabetes
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
A study comparing the antihypertensives Valsartan and Lisinporil when doses are in the morning and comparing a morning dose of Valsartan with an evening dose.
Eligibility Criteria
Inclusion
- \- 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
Exclusion
- \- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
1099 Patients enrolled
Trial Details
Trial ID
NCT00241124
Start Date
April 1 2004
End Date
June 1 2005
Last Update
November 23 2011
Active Locations (1)
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1
Investigative Centers, Germany