- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00170924
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.
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
New Jersey
-
East Hanover, New Jersey, United States, 07936
- Novartis Pharmaceuticals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change from baseline in diastolic heart function at 38 weeks, measured by echocardiogram
|
Secondary Outcome Measures
Outcome Measure |
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Change from baseline in the wall thickness of left heart ventricle after 38 weeks
|
Change from baseline in the size (mass) left heart ventricle after 38 weeks
|
Change from baseline in heart function after 38 weeks
|
Change from baseline in circulating marker of ventricular function after 38 weeks
|
Change from baseline in circulating marker of inflammation
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CVAL489AUS52
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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