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Completed

NCT Number: NCT00294086

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

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.

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Key information

Conditions

Chronic Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Valsartan 160 mg

Drug

valsartan 160 mg BID

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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)

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Feb 20, 2006
Registry last updated
Jun 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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