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

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

A STUDY COMPARING THE ANTI-HYPERTENSIVES VALSARTAN AND LISINPORIL WHEN DOSES ARE IN THE MORNING AND COMPARING A MORNING DOSE OF VALSARTAN WITH AN EVENING DOSE

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: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

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:

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

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.

Investigative Centers, Germany

Last updated: November 13, 2006