Status:
COMPLETED
A Study of Valsartan Administered Once Daily Versus Twice Daily, in Patients With Stable, Chronic Heart Failure
Lead Sponsor:
Novartis
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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, a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00294086
Start Date
December 1 2005
End Date
January 1 2007
Last Update
June 8 2011
Active Locations (1)
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1
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936