Clinical trial NCT00241124: Comparison Of Morning And Evening Dosing Of Valsartan And Lisinopril In Patients With Diabetes
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: hypertension
valsartan
morning/evening dosing
lisinopril
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 1099
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Average 24 hour blood pressure less than 130/80 mmHg after 26 weeks
measure: Change from baseline in systolic 24 hour blood pressure after 12 weeks
Secondary outcomes:
measure: Change from baseline manual blood pressure and pulse pressure after 26 weeks
measure: Change from baseline markers of endothelial function, fibrosis, and other blood measurements of hypertension after 12 and 26 weeks
measure: Changes in ambulatory blood pressure measurements at various timepoints up to 26 weeks
measure: Change from baseline heart size after 26 weeks
measure: Adverse events, serious adverse events, laboratory values, physical examinations, vital signs for up to 26 weeks
Other outcomes:
Locations:
city: Investigative Centers
country: Germany
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Zappe DH, Crikelair N, Kandra A, Palatini P. Time of administration important? Morning versus evening dosing of valsartan. J Hypertens. 2015 Feb;33(2):385-92. doi: 10.1097/HJH.0000000000000397.