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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00241124
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : November 23, 2011
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: valsartan Drug: lisinopril Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1099 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : April 2004
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Average 24 hour blood pressure less than 130/80 mmHg after 26 weeks
  2. Change from baseline in systolic 24 hour blood pressure after 12 weeks

Secondary Outcome Measures :
  1. Change from baseline manual blood pressure and pulse pressure after 26 weeks
  2. Change from baseline markers of endothelial function, fibrosis, and other blood measurements of hypertension after 12 and 26 weeks
  3. Changes in ambulatory blood pressure measurements at various timepoints up to 26 weeks
  4. Change from baseline heart size after 26 weeks
  5. Adverse events, serious adverse events, laboratory values, physical examinations, vital signs for up to 26 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts 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 exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00241124

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Investigative Centers, Germany
Sponsors and Collaborators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Novartis Identifier: NCT00241124    
Other Study ID Numbers: CVAL489A2420
First Posted: October 18, 2005    Key Record Dates
Last Update Posted: November 23, 2011
Last Verified: November 2011
Keywords provided by Novartis:
morning/evening dosing
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs