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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

Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Heart Failure; High Blood B-type (or Brain) Natriuretic Peptide (BNP) Level

Intervention: olmesartan medoxomil + candesartan cilexetil placebo (Drug); olmesartan medoxomil placebo + candesartan cilexetil (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Daiichi Sankyo Europe, GmbH

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Absolute BNP change from week 0 to 24 of treatment

Secondary outcome:

Proportion of BNP responders at week 4, 8, 16 and 24 (BNP levels reduced to 350 pg/ml or less at all time points)

BNP change from week 0 to week 4, 8, and 16

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)

Event-free survival

Time-to-death

Time-to-first cardiovascular event

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

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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)

Locations and Contacts

Bron, France

Cedex, France

Cholet, France

Langres, France

Mannheim, France

Pontoise, France

Roubaix, France

Bad Nauheim, Germany

Berlin, Germany

Lambrecht, Germany

Ad Delft, Netherlands

Additional Information

Starting date: June 2008
Last updated: August 6, 2010

Page last updated: August 20, 2015

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