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

Chronic Heart Failure Clinical Trial

— OLMEBNP  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00679484
• Other study ID #: DSE-866-45
• Secondary ID: 2007-003060-22 E
• Status: Terminated
• Phase: Phase 3
• Start date: June 2008
• Est. completion date: November 2009

Study information

• Verified date: August 2010
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare olmesartan medoxomil to candesartan cilexetil in reducing BNP, a prognostic biomarker of heart failure, at week 24

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 400
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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 If a female becomes pregnant during the study, she has to be withdrawn immediately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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure
• High Blood B-type (or Brain) Natriuretic Peptide (BNP) Level

Intervention

Drug:
• olmesartan medoxomil + candesartan cilexetil placebo
Dosage form: tablet; frequency: daily; duration: 24 weeks
• olmesartan medoxomil placebo + candesartan cilexetil
Dosage form: tablets; frequency: daily; duration: 24 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Countries where clinical trial is conducted

France,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute BNP change from week 0 to 24 of treatment		24 weeks
Secondary	Proportion of BNP responders at week 4, 8, 16 and 24 (BNP levels reduced to 350 pg/ml or less at all time points)		24 weeks maximum
Secondary	BNP change from week 0 to week 4, 8, and 16		16 weeks maximum
Secondary	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)		24 weeks
Secondary	Event-free survival		24 weeks
Secondary	Time-to-death		24 weeks
Secondary	Time-to-first cardiovascular event		24 weeks maximum
Secondary	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		24 weeks