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

Phase 4

Completed

• Conditions: Hypertension

• Registration Number: NCT00241124
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2005-10-14
• Study First Submitted QC: 2005-10-17
• Study First Posted: 2005-10-18
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-22
• Last Update Posted: 2011-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1099

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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