Clinical trial NCT00679484: 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
Official title: A 24-Week Multicentre, Randomized, Double-Blind, Controlled, Parallel Group Non-Inferiority Study to Assess the Efficacy and Safety of Olmesartan Medoxomil Versus Candesartan Cilexetil in Patients With Symptomatic Heart Failure (NYHA II-IV)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Heart Failure
High Blood B-type (or Brain) Natriuretic Peptide (BNP) Level
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2008-05-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

* 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 Criteria:

* 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 If a female becomes pregnant during the study, she has to be withdrawn immediately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)

Primary outcomes:
measure: Absolute BNP change from week 0 to 24 of treatment
timeFrame: 24 weeks
Secondary outcomes:
measure: Proportion of BNP responders at week 4, 8, 16 and 24 (BNP levels reduced to 350 pg/ml or less at all time points)
timeFrame: 24 weeks maximum
measure: BNP change from week 0 to week 4, 8, and 16
timeFrame: 16 weeks maximum
measure: Incidence of critical events at 24 weeks: All cause death; Cardiovascular death defined as death due to: HF, myocardial infarction, cardiac arrhythmia, stroke/cerebral vascular accident, other cardiovascular cause (e.g., aneurysm or pulmonary embolism)
timeFrame: 24 weeks
measure: Event-free survival
timeFrame: 24 weeks
measure: Time-to-death
timeFrame: 24 weeks
measure: Time-to-first cardiovascular event
timeFrame: 24 weeks maximum
measure: Change in clinical status: Improvement: patient alive without any cardiovascular event with an improvement of at least one NYHA functional class level; No change: patient alive without any cardiovascular event with stable functional NYHA class
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bron
country: France
city: Cedex
country: France
city: Cholet
country: France
city: Langres
country: France
city: Mannheim
country: France
city: Pontoise
country: France
city: Roubaix
country: France
city: Bad Nauheim
country: Germany
city: Berlin
country: Germany
city: Lambrecht
country: Germany
city: Ad Delft
country: Netherlands
Study officials:
References: