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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00294086
First received: February 17, 2006
Last updated: June 7, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Chronic Heart Failure
Drug: valsartan 160 mg
Drug: valsartan 160 mg BID
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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:
  • Patients reaching target dose at 10 weeks
  • Change from baseline in systolic blood pressure at each study visit
  • Change from baseline in diastolic blood pressure at each study visit
  • Change from baseline in blood potassium at each study visit
  • Change from baseline in blood creatinine at each study visit

Estimated Enrollment: 160
Study Start Date: December 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Novartis

Additional 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
Study First Received: February 17, 2006
Last Updated: June 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
valsartan,
chronic heart failure,

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

ClinicalTrials.gov processed this record on April 17, 2014