Status:
TERMINATED
Study to Demonstrate the Non-inferiority of Olmesartan Medoxomil Versus Candesartan Cilexetil in Reducing Blood B-type (or Brain) Natriuretic Peptide Levels at Week 24
Lead Sponsor:
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Conditions:
Chronic Heart Failure
High Blood B-type (or Brain) Natriuretic Peptide (BNP) Level
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
This study will compare olmesartan medoxomil to candesartan cilexetil in reducing BNP, a prognostic biomarker of heart failure, at week 24
Eligibility Criteria
Inclusion
- Male or female, adult, out-patients aged between 18 and 85 years
- Patients with documented hospital admission within the previous 3 months before randomization with discharge diagnosis of CHF
- Patients with functional NYHA class II-IV with LVEF \< 40% assessed within the last 3 months
- Patients with blood BNP levels \> 400 pg/ml or NT-ProBNP levels \> 1500 pg/ml
- Patients with CHF due to ischemic heart disease, idiopathic dilated cardiomyopathy (IDC), mitral or aortic insufficiency or hypertension
- Patients with stable conventional treatment with diuretics, ACEI and/or beta-blockers and/or aldosterone antagonists for at least 2 months prior to randomisation, unless documented contraindication or intolerance
Exclusion
- Females who are pregnant or plan a pregnancy during the time of the trial, are nursing or are of childbearing potential and not using acceptable methods of contraception. If a female becomes pregnant during the study, she has to be withdrawn immediately
- Patients with current hospitalisation due to heart failure
- Patients with stroke or transient ischemic attack (TIA) within the last 3 months
- Patients with acute coronary syndrome, myocardial infarction, coronary artery bypass or angioplasty within 3 months
- Planned cardiac surgery, revascularization or resynchronization within the study period
- Patients with operable valvular disease or significant obstructive cardiomyopathy
- Patients with bradycardia \[heart rate (HR) \< 50 bpm\]
- Patients with hypotension \[systolic blood pressure (SBP) \< 90 mmHg\]
- Patients with obstructive pneumopathy
- Patients with clinical significant renal failure (creatininemia \> 200 micromol/l)
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00679484
Start Date
June 1 2008
End Date
November 1 2009
Last Update
December 24 2018
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Bron, France
2
Cedex, France
3
Cholet, France
4
Langres, France