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

Novartis1,099 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,099

Conditions

Hypertension

Interventions

valsartanDRUG

lisinoprilDRUG

Eligibility

Sex: ALLMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

Unnamed facility

Investigative Centers, Germany

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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