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

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ClinicalTrials.gov Identifier: NCT00241124
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : November 23, 2011
Information provided by (Responsible Party):

October 14, 2005
October 18, 2005
November 23, 2011
April 2004
June 2005   (Final data collection date for primary outcome measure)
  • 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
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Complete list of historical versions of study NCT00241124 on ClinicalTrials.gov Archive Site
  • 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
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Comparison Of Morning And Evening Dosing Of Valsartan And Lisinopril In Patients With Diabetes
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
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.
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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Drug: valsartan
  • Drug: lisinopril
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2005
June 2005   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP