Comparison Of Morning And Evening Dosing Of Valsartan And Lisinopril In Patients With Diabetes
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: valsartan (Drug); lisinopril (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s): Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
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.
Clinical Details
Official title: 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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Average 24 hour blood pressure less than 130/80 mmHg after 26 weeksChange from baseline in systolic 24 hour blood pressure after 12 weeks
Secondary outcome: Change from baseline manual blood pressure and pulse pressure after 26 weeksChange from baseline markers of endothelial function, fibrosis, and other blood measurements of hypertension after 12 and 26 weeks Changes in ambulatory blood pressure measurements at various timepoints up to 26 weeks Change from baseline heart size after 26 weeks Adverse events, serious adverse events, laboratory values, physical examinations, vital signs for up to 26 weeks
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- - 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.
Locations and Contacts
Investigative Centers, Germany
Additional Information
Starting date: April 2004
Last updated: November 22, 2011
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