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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00241124
First received: October 14, 2005
Last updated: November 22, 2011
Last verified: November 2011

October 14, 2005
November 22, 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
Not Provided
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
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hypertension
  • Drug: valsartan
  • Drug: lisinopril
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1099
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.

Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00241124
CVAL489A2420
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2011

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