Hypertension
Conditions
Keywords
hypertension, valsartan, morning/evening dosing, lisinopril
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.
Interventions
DRUGvalsartan
DRUGlisinopril
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Changes in ambulatory blood pressure measurements at various timepoints up to 26 weeks | — |
| Change from baseline manual blood pressure and pulse pressure after 26 weeks | — |
| Adverse events, serious adverse events, laboratory values, physical examinations, vital signs for up to 26 weeks | — |
| Change from baseline heart size after 26 weeks | — |
| Change from baseline markers of endothelial function, fibrosis, and other blood measurements of hypertension after 12 and 26 weeks | — |
Countries
Germany
Outcome results
None listed