Chronic Heart FailurePhase 3OLMEBNPNCT00679484
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
A Phase 3 study of Chronic Heart Failure and High Blood B-type (or Brain) Natriuretic Peptide (BNP) Level, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company at 11 sites in 3 countries.
Trial summary
This study will compare olmesartan medoxomil to candesartan cilexetil in reducing BNP, a prognostic biomarker of heart failure, at week 24 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Heart Failure, High Blood B-type (or Brain) Natriuretic Peptide (BNP) Level
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 11 sitesin 3 countries
- Study dates
- Jun 2008to Nov 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 If a female becomes pregnant during the study, she has to be withdrawn immediately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
Show all 10Show fewer
- 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)
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
France7 sites
Study site
Bron
Study site
Cedex
Study site
Cholet
Study site
Langres
Study site
Mannheim
Study site
Pontoise
Study site
Roubaix
About this study
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)
This study will compare olmesartan medoxomil to candesartan cilexetil in reducing BNP, a prognostic biomarker of heart failure, at week 24
- Being tested
- olmesartan medoxomil + candesartan cilexetil placebo, olmesartan medoxomil placebo + candesartan cilexetil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olmesartan medoxomil + candesartan cilexetil placeboDrug
Dosage form: tablet; frequency: daily; duration: 24 weeks
olmesartan medoxomil placebo + candesartan cilexetilDrug
Dosage form: tablets; frequency: daily; duration: 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: olmesartan medoxomil + candesartan cilexetil placebo |
| 2 | Experimental | Not described Receives: Drug: olmesartan medoxomil placebo + candesartan cilexetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute BNP change from week 0 to 24 of treatment
Measured: 24 weeks
Secondary outcomes (7)
Proportion of BNP responders at week 4, 8, 16 and 24 (BNP levels reduced to 350 pg/ml or less at all time points)
Measured: 24 weeks maximum
BNP change from week 0 to week 4, 8, and 16
Measured: 16 weeks maximum
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)
Measured: 24 weeks
Event-free survival
Measured: 24 weeks
Time-to-death
Measured: 24 weeks
Time-to-first cardiovascular event
Measured: 24 weeks maximum
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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study startJun 2008
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: Lack of subject recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679484
- Sponsor's protocol ID
- DSE-866-45
- Other IDs
- 2007-003060-22 EUDRACT Number
- Acronym
- OLMEBNP
- Status last verified
- Aug 2010
- First submitted
- 14 May 2008
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00679484
- Acronym / sponsor ID
- OLMEBNP / DSE-866-45
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of subject recruitment
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 16 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare olmesartan medoxomil to candesartan cilexetil in reducing BNP, a prognostic biomarker of heart failure, at week 24
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: olmesartan medoxomil + candesartan cilexetil placebo |
| 2 | Experimental | Drug: olmesartan medoxomil placebo + candesartan cilexetil |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olmesartan medoxomil + candesartan cilexetil placeboDosage form: tablet; frequency: daily; duration: 24 weeks | Drug | 1 |
| olmesartan medoxomil placebo + candesartan cilexetilDosage form: tablets; frequency: daily; duration: 24 weeks | Drug | 2 |
Primary outcome
Absolute BNP change from week 0 to 24 of treatment
Time frame: 24 weeks
7 secondary outcomes
Proportion of BNP responders at week 4, 8, 16 and 24 (BNP levels reduced to 350 pg/ml or less at all time points)
Time frame: 24 weeks maximum
BNP change from week 0 to week 4, 8, and 16
Time frame: 16 weeks maximum
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)
Time frame: 24 weeks
Event-free survival
Time frame: 24 weeks
Time-to-death
Time frame: 24 weeks
Time-to-first cardiovascular event
Time frame: 24 weeks maximum
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
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: Lack of subject recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Chronic Heart Failure and High Blood B-type (or Brain) Natriuretic Peptide (BNP) Level, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France, Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of subject recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute BNP change from week 0 to 24 of treatment (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2018.