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Efficacy and Safety of Valsartan Versus Placebo on Exercise Tolerance in Patients With Heart Failure

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171106
First received: September 10, 2005
Last updated: November 16, 2016
Last verified: November 2016

September 10, 2005
November 16, 2016
December 2002
August 2007   (final data collection date for primary outcome measure)
Change in baseline exercise test after 15-42 days and 14 weeks
Not Provided
Complete list of historical versions of study NCT00171106 on ClinicalTrials.gov Archive Site
  • Oxygen consumption during the exercise test
  • Exercise test blood pressure
  • Borg score of breathlessness
  • 6-minute walk test at baseline and after 14 weeks
  • Quality of life assessment at baseline and after 14 weeks
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Efficacy and Safety of Valsartan Versus Placebo on Exercise Tolerance in Patients With Heart Failure
A Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Determine the Effects of Valsartan on Exercise Time in Subjects With Symptomatic Diastolic Heart Failure
This study will test the effects of valsartan versus placebo on exercise tolerance in patients with symptoms of heart failure
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diastolic Dysfunction, Symptomatic Heart Failure
Drug: valsartan
Not Provided
Parthasarathy HK, Pieske B, Weisskopf M, Andrews CD, Brunel P, Struthers AD, MacDonald TM. A randomized, double-blind, placebo-controlled study to determine the effects of valsartan on exercise time in patients with symptomatic heart failure with preserved ejection fraction. Eur J Heart Fail. 2009 Oct;11(10):980-9. doi: 10.1093/eurjhf/hfp120.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
February 2008
August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Symptomatic diastolic heart failure
  • Breathlessness with physical exertion

Exclusion Criteria:

  • Uncontrolled hypertension
  • Asthma, COPD, or abnormal lung function
  • History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
  • Liver, kidney, or pancreas disease
  • Allergy to valsartan

Other protocol-defined exclusion criteria may apply

Both
21 Years and older   (Adult, Senior)
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Contact information is only displayed when the study is recruiting subjects
Germany,   Switzerland
 
NCT00171106
CVAL489B2401
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Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP