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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Heart Diseases
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014