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

Novartis

Status and phase

Completed

Phase 4

Conditions

Hypertension

Treatments

Drug: lisinopril

Drug: valsartan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00241124

CVAL489A2420

Details and patient eligibility

About

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.

Enrollment

1,099 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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.