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CompletedNCT00294086Updated Jun 8, 2011

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

A Phase 2 interventional study of valsartan 160 mg and valsartan 160 mg BID in Chronic Heart Failure, sponsored by Novartis. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-06-08.

Sponsored by Novartis · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Heart Failure

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Keywords

  • valsartan,
  • chronic heart failure,
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 160 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
160 participants

Interventions

  • Drugvalsartan 160 mg
  • Drugvalsartan 160 mg BID
06

What researchers measure

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

07

Study locations

1 site
  • Novartis Pharmaceuticals
    East Hanover, New Jersey 07936, United States
08

References and documents

Publications

  • Anand IS, Deswal A, Kereiakes DJ, Purkayastha D, Zappe DH. Comparison of once-daily versus twice-daily dosing of valsartan in patients with chronic stable heart failure. Vasc Health Risk Manag. 2010 Aug 9;6:449-55. PubMed 20730060 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00294086
Lead sponsor
Novartis
First posted
Feb 20, 2006
Start date
Dec 2005
Primary completion
Jan 2007
Completion
Jan 2007
Last update
Jun 8, 2011

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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