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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00170924
First received: September 10, 2005
Last updated: November 7, 2011
Last verified: November 2011

September 10, 2005
November 7, 2011
August 2004
June 2006   (final data collection date for primary outcome measure)
Change from baseline in diastolic heart function at 38 weeks, measured by echocardiogram
Not Provided
Complete list of historical versions of study NCT00170924 on ClinicalTrials.gov Archive Site
  • 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
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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.
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Diastolic Dysfunction
  • Hypertension
Drug: Valsartan
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Solomon SD, Janardhanan R, Verma A, Bourgoun M, Daley WL, Purkayastha D, Lacourciere Y, Hippler SE, Fields H, Naqvi TZ, Mulvagh SL, Arnold JM, Thomas JD, Zile MR, Aurigemma GP; Valsartan In Diastolic Dysfunction (VALIDD) Investigators. Effect of angiotensin receptor blockade and antihypertensive drugs on diastolic function in patients with hypertension and diastolic dysfunction: a randomised trial. Lancet. 2007 Jun 23;369(9579):2079-87.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
317
June 2006
June 2006   (final data collection date for primary outcome measure)

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.

Both
45 Years and older
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00170924
CVAL489AUS52
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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