Comparison Of Morning And Evening Dosing Of Valsartan And Lisinopril In Patients With Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: valsartan
* Drug: lisinopril


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: valsartan|nan|
|Drug: lisinopril|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average 24 hour blood pressure less than 130/80 mmHg after 26 weeks |  |  | 
| Change from baseline in systolic 24 hour blood pressure after 12 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline manual blood pressure and pulse pressure after 26 weeks |  |  | 
| Change 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, valsartan, morning/evening dosing, lisinopril