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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00170924
Other study ID # CVAL489AUS52
Secondary ID
Status Completed
Phase Phase 4
First received September 10, 2005
Last updated November 7, 2011
Start date August 2004
Est. completion date June 2006

Study information

Verified date November 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 317
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers
Gender Both
Age group 45 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Valsartan


Locations

Country Name City State
United States Novartis Pharmaceuticals East Hanover New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in diastolic heart function at 38 weeks, measured by echocardiogram
Secondary Change from baseline in the wall thickness of left heart ventricle after 38 weeks
Secondary Change from baseline in the size (mass) left heart ventricle after 38 weeks
Secondary Change from baseline in heart function after 38 weeks
Secondary Change from baseline in circulating marker of ventricular function after 38 weeks
Secondary Change from baseline in circulating marker of inflammation
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