Status:
TERMINATED
Efficacy of Candesartan on Brain Natriuretic Peptide Levels in Subjects With Chronic Heart Failure
Lead Sponsor:
Takeda
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the effects of Candesartan, once daily (QD), added to ongoing chronic heart disease therapy in measuring brain natriuretic peptide in patients with chronic he...
Detailed Description
Chronic heart failure is a significant and increasing cause of morbidity and mortality, accounting for a current yearly prevalence of 5 million and a 5-year survival near 50% in the US. In addition, c...
Eligibility Criteria
Inclusion
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Stable, symptomatic New York Heart Association II-IV Chronic Heart Failure with Left Ventricular Ejection Fraction less than or greater than or greater than or equal to 40% treated with standard therapy including Angiotensin Converting Enzyme-inhibitors and/or beta-blockers. Patients with Left Ventricular Ejection Fraction greater than or equal to 40% had to be hospitalized for cardiovascular events during the past 12 months.
Exclusion
- History of prior treatment with Angiotensin-Receptor Blockers within two weeks from first.
- Severe or malignant hypertension (Systolic Blood Pressure / Diastolic Blood Pressure greater than 180/110 mmHg).
- Symptomatic hypotension.
- Acute myocardial infarction within one month from first visit.
- Stroke or transient ischemic attack within one month from first visit.
- Percutaneous transluminal coronary angioplasty or coronary artery by-pass graft within one month from first visit.
- Hemodynamically relevant arrhythmias.
- Implant of pacemakers, cardiac resynchronization therapy or cardioverters within 6 months prior the randomization.
- Hemodynamically relevant cardiac valvular defect.
- Constrictive pericarditis or active myocarditis.
- Likelihood of cardiac surgical intervention (of any type) during the overall treatment period.
- Evidence of angina pectoris in the previous month.
- Poorly controlled diabetes mellitus (glycemia greater than 140mg/mL or glycosylated hemoglobin greater than 8% obtained within three months from the study initiation).
- Untreated thyroid dysfunction.
- Renal artery stenosis.
- Angioedema of any etiology.
- Significant liver (aspartate aminotransferase, alanine aminotransferase, total bilirubin or alkaline phosphatase greater than twice the upper limit of normal range) or renal (serum creatinine greater than 2.0 mg/dL or serum potassium greater than 5.0 mmol/L) impairment.
- Anemia of any etiology (defined as hemoglobin levels less than 10.5 g/dL) or any other clinically relevant hematological disease.
- Any disease with malabsorption.
- Presence of any non-cardiac (e.g. cancer) disease that is likely to significantly (i.e. below 1 year from randomization) shorten life expectancy.
- History of chronic alcohol or drug/substance abuse, or presence of other conditions potentially able to affect study subjects' compliance.
- Known allergy, sensitivity or intolerance to study drugs and/or study drugs' formulation ingredients.
- Participation in another trial in the month preceding study entry.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
571 Patients enrolled
Trial Details
Trial ID
NCT00843154
Start Date
December 1 2005
End Date
July 1 2008
Last Update
June 11 2010
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