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A Study of Valsartan Administered Once Daily Versus Twice Daily, in Patients With Stable, Chronic Heart Failure

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ClinicalTrials.gov Identifier: NCT00294086
Recruitment Status : Completed
First Posted : February 20, 2006
Last Update Posted : June 8, 2011
Sponsor:
Information provided by:
Novartis

Brief Summary:
This study will evaluate the tolerability and safety of valsartan in patients with stable, chronic heart failure (NYHA Class ll-lll). The 12-week double blind study has a 2-week (maximum) screening, and a 10-week active treatment phase. In each of the treatment arms (QD and BID), patients are up-titrated to a maximum valsartan total daily dose of 320 mg. Patients remain on their prior CHF standard care therapy throughout the study period, and the up-titration of valsartan is based on patient tolerability.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Drug: valsartan 160 mg Drug: valsartan 160 mg BID Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A 12-Week Multicenter, 2-Arm Regimen, Exploratory Study to Evaluate the Tolerability and Safety of Valsartan Administered Once Daily vs Daily, in Patients With Stable, Chronic Heart Failure (NYHA Class Ll-lll)
Study Start Date : December 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Valsartan
U.S. FDA Resources




Primary Outcome Measures :
  1. Tolerability as assessed by laboratory tests for potassium, creatinine, and on systolic blood pressure, symptoms of low blood pressure, and symptoms of heart failure

Secondary Outcome Measures :
  1. Patients reaching target dose at 10 weeks
  2. Change from baseline in systolic blood pressure at each study visit
  3. Change from baseline in diastolic blood pressure at each study visit
  4. Change from baseline in blood potassium at each study visit
  5. Change from baseline in blood creatinine at each study visit


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria

  • Males or females aged 18 years or older
  • Diagnosis of chronic heart failure (CHF), in NYHA Class ll-lll beginning at least 3 months prior to Visit 1
  • Patients must remain on their prior standard care CHF therapy

Exclusion Criteria

  • Diagnosis of severe hypertension (SBP>180 and DBP>110 mm Hg)
  • Right heart failure due to pulmonary disease
  • Presence of rapidly deteriorating heart failure
  • MI or cardiac surgery, including PTCA within 3 months of Visit 1
  • Unstable angina or coronary artery disease likely to require CABG or PTCA
  • Other protocol-defined exclusion criteria may apply.

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): NCT00294086


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00294086     History of Changes
Other Study ID Numbers: CVAL489BUS70
First Posted: February 20, 2006    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011

Keywords provided by Novartis:
valsartan,
chronic heart failure,

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