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To Find Out Whether Valsartan With or Without Other Blood Pressure Medications Would Improve the Ability of the Heart to Fill and Empty, and the Ability of the Heart Muscle to Relax Adequately in People With High Blood Pressure.

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ClinicalTrials.gov Identifier: NCT00170924
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 8, 2011
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Patients who have had high blood pressure for a long time may have diastolic dysfunction. Diastolic Dysfunction is when your heart has difficulty filling and emptying, and relaxing adequately.

This study is to find out if Valsartan) will improve the ability of the heart to fill, empty, and relax appropriately when given alone or with other medicines to treat high blood pressure.


Condition or disease Intervention/treatment Phase
Diastolic Dysfunction Hypertension Drug: Valsartan Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 317 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Effect of the Angiotensin II Antagonist Valsartan on Diastolic Function in Patients With Hypertension and Diastolic Dysfunction
Study Start Date : August 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Valsartan
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in diastolic heart function at 38 weeks, measured by echocardiogram

Secondary Outcome Measures :
  1. Change from baseline in the wall thickness of left heart ventricle after 38 weeks
  2. Change from baseline in the size (mass) left heart ventricle after 38 weeks
  3. Change from baseline in heart function after 38 weeks
  4. Change from baseline in circulating marker of ventricular function after 38 weeks
  5. Change from baseline in circulating marker of inflammation

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Diagnosis/History of high blood pressure
  • Male or Female age 45 years or older

Exclusion Criteria:

  • History of stroke, transient ischemic attack or heart attack within the last 6 months
  • A hospital admission for congestive heart failure within the last year
  • Use of certain high blood pressure medications such as ACE inhibitors, Angiotensin Receptor Blockers or aldosterone antagonists or other agents that may work in the same pathway (RAAS) as valsartan within the past 3 months.

Other protocol-defined exclusion criteria may apply.

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00170924


Locations
United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Novartis Patient Recruitment Website  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00170924     History of Changes
Other Study ID Numbers: CVAL489AUS52
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011

Keywords provided by Novartis:
Hypertension, High Blood Pressure, Diastolic Dysfunction,
Heart Disease

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
 Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action