Heart FailurePhase 3NCT00775840
Efficacy of Candesartan on Symptomatic Heart Failure in Treating Diabetic and Hypertensive Patients.
A Phase 3 study testing Candesartan in people with Heart Failure, run by Takeda at 37 sites in Germany.
Trial summary
The purpose of this study is to determine the effects of candesartan, once daily (QD), on the N-terminal pro-B-type Natriuretic Peptide laboratory marker in subjects with symptomatic heart failure with diastolic dysfunction. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Candesartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 37 sitesGermany
- Study dates
- Jan 2008to Dec 2008
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus type 2 - insulin dependent or orally treated or managed by diet for at least 3 Months.
- Normotension or controlled hypertension with sitting Systolic Blood Pressure less than 140 mmHg and/or sitting Diastolic Blood Pressure less than 90 mmHg.
- Regular sinus rhythm or atrial fibrillation with a medicamental-achieved rate control of less than 100 bpm as confirmed by electrocardiogram recordings.
- Echocardiographic evidence of a preserved Left Ventricular Ejection Fraction greater than or equal to 45% (assessed by the modified Simpson method), with further doppler-echocardiographic criteria for diastolic dysfunction grade I-IV.
- New York Heart Association classification of II or III in a stable condition since at least 3 months.
- Existing background heart failure therapy with an Angiotensin-Converting Enzyme Inhibitor alone or together with further preparations in a constant regimen since at least 1 month, in case of beta-blockers since at least 3 months.
Show all 9Show fewer
- N-terminal pro-B-type Natriuretic Peptide greater than or equal to 250 pg/ml measured at screening visit or collected from a dated previous laboratory document not older than 3 months.
- No previous therapy with Angiotensin-Receptor Blockers during the last 4 weeks prior to the study.
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Who cannot join
- Impaired renal function (serum creatinine greater than 2.2 mg/dl or greater than 194 μmol/l).
- Known bilateral renal artery stenosis or interventional treatment for renal artery stenosis in the last year.
- State after kidney transplantation.
- Serum potassium greater than 5.5 mmol/l or glycosylated hemoglobin greater than 9.5 %.
- Cor pulmonale or primary pulmonary disease with dyspnea at rest.
- Known disposition to episodes of symptomatic hypotension or sitting Systolic Blood Pressure less than 95 mmHg at baseline.
Show all 24Show fewer
- Acute coronary syndrome or any form of unstable chronic Coronary Artery Disease where the indication of a coronary intervention is either planned in short or medium term or can not be clearly excluded for the period of the study.
- Any history of: myocardial infarction, previous Percutaneous Transluminal Coronary Angioplasty with revascularization, stent implantation, Coronary Artery Bypass Graft or open heart surgery.
- Tachycardia at rest greater than 100 bpm as confirmed by electrocardiogram recordings.
- Known clinically relevant rhythm disorders (e.g., tachyarrhythmias, salves of supraventricular or ventricular extrasystoles or atrial fibrillation without ventricular rate control) or symptoms suggesting a significant rhythm disorder (e.g., recurrent syncopes).
- Primary valvular diseases and/or restrictive or obstructive cardiomyopathy.
- Existing ventricular assist devices.
- Relevant liver diseases (cholestasis or alanine aminotransferase/aspartate aminotransferase greater than 2 times the upper limit of normal or gamma- glutamyltransferase greater than 3 times the upper limit of normal).
- History of primary hyperaldosteronism, of cancer in the last 5 years or of another wasting disease with life expectancy of less than 2 years.
- Known hypersensitivity to Candesartan Cilexetil.
- Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
- Need for maintenance therapy with Non-steroidal anti-inflammatory drugs or Cox-2-inhibitors.
- Use of other Angiotensin-Receptor Blockers.
- Any history of life-threatening diseases.
- History of drug addiction and/or an extensive use of alcohol.
- Acute coronary syndrome or unstable angina pectoris and any coronary artery disease that was not stable during the last 3 months prior to inclusion.
- Patients who are dependent on a permanently paced pacemaker (i.e. a patient with a device that is not pacing during the echocardiographic examination can enter the study).
- Open heart surgery for other reasons than coronary revascularization
- Participation in another clinical investigation within 30 days prior to enrolment or for the course of the present study.
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
Germany37 sites
Study site
Bad Friedrichshall, Baden-Wurttemberg
Study site
Bad Homburg, Hesse
Study site
Bad Kreuznach, Rhineland-Palatinate
Study site
Bad Nauheim, Hesse
Study site
Berlin, State of Berlin
Study site
Coswig, Saxony-Anhalt
Study site
Darmstadt, Hesse
Study site
Dresden, Saxony
Study site
Erfurt, Thuringia
Study site
Essen, North Rhine-Westphalia
Study site
Frankfurt am Main, Hesse
Study site
Gelsenkirchen, North Rhine-Westphalia
Study site
Giessen, Hesse
Study site
Gladbeck, North Rhine-Westphalia
Study site
Hartmannsdorf, Saxony
Study site
Heidelberg, Baden-Wurttemberg
Study site
Jena, Thuringia
Study site
Kassel, Hesse
Study site
Langenfeld, North Rhine-Westphalia
Study site
Leipzig, Saxony
Study site
Leisnig, Saxony
Study site
Limburg an der Lahn, Hesse
Study site
Ludwigsburg, Baden-Wurttemberg
Study site
Machem, Saxony
Study site
Markkleeberg, Saxony
Study site
Melsungen, Hesse
Study site
Mühlheim am Main, Hesse
Study site
Neukirchen, Saarland
Study site
Nienburg, Lower Saxony
Study site
Nordhausen, Thuringia
Study site
Northeim, Lower Saxony
Study site
Paderborn, North Rhine-Westphalia
Study site
Riesa, Saxony
Study site
Siegen, North Rhine-Westphalia
Study site
Wermsdorf, Saxony
Study site
Weyhe, Lower Saxony
Study site
Wiesbaden, Hesse
About this study
Official title: Candesartan "Added" Therapy for Treatment Optimization of Symptomatic Heart Failure With Diastolic Dysfunction in Diabetic and Hypertensive Patients A Randomized, Placebo-controlled, Double-blind, Parallel-group and Multicenter Clinical Phase III Study Investigating the Effects on NT-proBNP Over 6 Months
The purpose of this study is to determine the effects of candesartan, once daily (QD), on the N-terminal pro-B-type Natriuretic Peptide laboratory marker in subjects with symptomatic heart failure with diastolic dysfunction.
Read the detailed description
Heart diseases are the number one cause of death in developed countries and in particular chronic or congestive heart failure is the leading cause of hospitalization in patients older than 65 years. It is still increasing in prevalence and, in spite of significant advances in therapy, mortality rates remain high: 30% to 40% of patients with advanced disease, and 5% to 10% of patients with mild symptoms will die within 5 to 10 years.
A relevant proportion of the heart failure patients (30 - 50%) suffering from edema and dyspnea have normal or minimally impaired left ventricular ejection fraction (preserved left ventricular ejection fraction) with diastolic abnormalities in echocardiography. Features of diastolic dysfunction are the stiffness, the decreased compliance and the impaired relaxation of the left ventricle. As a result, the left ventricle has a limited filling capacity during a normal left atrial pressure.
Hypertension and/or diabetes are the most predisposing conditions whereas left ventricular hypertrophy is regarded as the linking intermediate pathological condition. Moreover, recent studies showed that patients with symptomatic heart failure and an ejection fraction greater than 40% have a poor prognosis with relatively high mortality and hospitalization rates. Thus, in hypertensive patients, diastolic dysfunction has shown to be a predictor of morbidity.
Diastolic dysfunction is also a frequent finding in type 2 diabetes without symptoms and signs of heart disease. As long as it is independent of ischemic heart disease, it is presumably due to diabetic cardiomyopathy. Once aggravated to heart failure, diastolic dysfunction often coexists with systolic dysfunction as a consequence of coronary artery disease with a limited coronary reserve.
This study will determine whether pharmacological intervention into the Renin Angiotensin Aldosterone System exerted by the Angiotensin-Receptor Blocker Candesartan on top of an Angiotensin-Converting Enzyme Inhibitor-based therapy may lead to a significant drop of N-terminal pro-B-type Natriuretic Peptide. This neurohormonal laboratory marker is sufficient enough to simultaneously indicate the improvement of the causing diastolic dysfunction and associated heart failure symptoms as assessed by objective echocardiographic and clinical parameters.
Total time for participants in this study is approximately 26 weeks.
- Conditions
- Heart Failure
- Being tested
- Candesartan, Placebo
- Keywords
- Cardiac Failure, Congestive Heart Failure, Drug Therapy, Hypertension, Diabetes Mellitus
- Medical subject headings
- Heart Failure, Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CandesartanDrug
Also called BLOPRESS®
Candesartan up to 32 mg, tablets, orally, once daily and ongoing angiotensin-converting enzyme inhibitor/beta-blocker therapy for up to 24 weeks.
PlaceboDrug
Candesartan matching-placebo tablets, orally, once daily and ongoing angiotensin-converting enzyme inhibitor/beta-blocker therapy for up to 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Candesartan QD + Heart Failure Therapy | Experimental | (with angiotensin-converting enzyme-inhibitors/beta-blockers) Receives: Drug: Candesartan |
| Placebo QD + Heart Failure Therapy | Placebo comparator | (with angiotensin-converting enzyme-inhibitors/beta-blockers) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from Baseline in N-terminal pro-B-type Natriuretic Peptide biomarker.
Measured: Week 24 or Final Visit.
Secondary outcomes (22)
Mean change in N-terminal pro-B-type Natriuretic Peptide (log-transformed).
Measured: Weeks 6 and 24 or Final Visit.
Change from Baseline in Short Form-36 Health Survey score.
Measured: Week 24 or Final Visit.
Change from Baseline in Cystatin C.
Measured: Week 24 or Final Visit.
Change from Baseline in Adiponectin.
Measured: Week 24 or Final Visit.
Change from Baseline in Glycosylated Hemoglobin.
Measured: Week 24 or Final Visit.
Change from Baseline in Urinary Albumin Excretion.
Measured: Week 24 or Final Visit.
Change from Baseline in estimated Glomerular Filtration Rate and Cystatin C.
Measured: Week 24 or Final Visit.
Mean Change in New York Heart Association classification results.
Measured: Week 24 or Final Visit.
Body Weight.
Measured: Week 24 or Final Visit.
Blood Pressure.
Measured: Week 24 or Final Visit.
Echocardiograms.
Measured: Week 24 or Final Visit.
Correlations of N-terminal pro-B-type Natriuretic Peptide with New York Heart Association Classification Results.
Measured: Week 24 or Final Visit.
Correlations of N-terminal pro-B-type Natriuretic Peptide with short Form-36 Health Survey Score.
Measured: Week 24 or Final Visit.
Correlations of N-terminal pro-B-type Natriuretic Peptide with Blood Pressure Results.
Measured: Week 24 or Final Visit.
Subgroup evaluations regarding beta-blocker therapy and New York Heart Association class (II/III).
Measured: Week 24 or Final Visit.
Subgroup evaluations in terms of the different possible dosages of study medication.
Measured: Weeks 6 to 24 or Final Visit.
Subgroup evaluations based on different baseline levels of estimated Glomerular Filtration Rate.
Measured: Week 24 or Final Visit.
Subgroup evaluations based on different baseline levels of Cystatin C.
Measured: Week 24 or Final Visit.
Subgroup evaluations based on different baseline levels of N-terminal pro-B-type Natriuretic Peptide.
Measured: Week 24 or Final Visit.
Comparison from Baseline on the concomitant use of Loop Diuretics.
Measured: Weeks 6 and 24 or Final Visit.
Transition from sinus rhythm to permanent atrial fibrillation based on electrocardiogram recordings.
Measured: Week 24 or Final Visit.
Progression of preserved (Left Ventricular Ejection Fraction greater than or equal to 45%) to impaired systolic dysfunction (Left Ventricular Ejection Fraction less than 45%), based on echocardiographic results.
Measured: Week 24 or Final Visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director, Study director, Takeda Pharma Gmbh, Aachen (Germany)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775840
- Sponsor's protocol ID
- BLO K026
- Other IDs
- 2007-003070-26, D-CAN-546, U1111-1113-9515
- Status last verified
- Jun 2010
- First submitted
- 16 Oct 2008
- Last updated
- 22 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Candesartan "Added" Therapy for Treatment Optimization of Symptomatic Heart Failure With Diastolic Dysfunction in Diabetic and Hypertensive Patients A Randomized, Placebo-controlled, Double-blind, Parallel-group and Multicenter Clinical Phase III Study Investigating the Effects on NT-proBNP Over 6 Months
- ClinicalTrials.gov ID
- NCT00775840
- Acronym / sponsor ID
- BLO K026
- Conditions
- Heart Failure
- Keywords
- Cardiac Failure, Congestive Heart Failure, Drug Therapy, Hypertension, Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Oct 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.
The purpose of this study is to determine the effects of candesartan, once daily (QD), on the N-terminal pro-B-type Natriuretic Peptide laboratory marker in subjects with symptomatic heart failure with diastolic dysfunction.
Detailed description
Heart diseases are the number one cause of death in developed countries and in particular chronic or congestive heart failure is the leading cause of hospitalization in patients older than 65 years. It is still increasing in prevalence and, in spite of significant advances in therapy, mortality rates remain high: 30% to 40% of patients with advanced disease, and 5% to 10% of patients with mild symptoms will die within 5 to 10 years.
A relevant proportion of the heart failure patients (30 - 50%) suffering from edema and dyspnea have normal or minimally impaired left ventricular ejection fraction (preserved left ventricular ejection fraction) with diastolic abnormalities in echocardiography. Features of diastolic dysfunction are the stiffness, the decreased compliance and the impaired relaxation of the left ventricle. As a result, the left ventricle has a limited filling capacity during a normal left atrial pressure.
Hypertension and/or diabetes are the most predisposing conditions whereas left ventricular hypertrophy is regarded as the linking intermediate pathological condition. Moreover, recent studies showed that patients with symptomatic heart failure and an ejection fraction greater than 40% have a poor prognosis with relatively high mortality and hospitalization rates. Thus, in hypertensive patients, diastolic dysfunction has shown to be a predictor of morbidity.
Diastolic dysfunction is also a frequent finding in type 2 diabetes without symptoms and signs of heart disease. As long as it is independent of ischemic heart disease, it is presumably due to diabetic cardiomyopathy. Once aggravated to heart failure, diastolic dysfunction often coexists with systolic dysfunction as a consequence of coronary artery disease with a limited coronary reserve.
This study will determine whether pharmacological intervention into the Renin Angiotensin Aldosterone System exerted by the Angiotensin-Receptor Blocker Candesartan on top of an Angiotensin-Converting Enzyme Inhibitor-based therapy may lead to a significant drop of N-terminal pro-B-type Natriuretic Peptide. This neurohormonal laboratory marker is sufficient enough to simultaneously indicate the improvement of the causing diastolic dysfunction and associated heart failure symptoms as assessed by objective echocardiographic and clinical parameters.
Total time for participants in this study is approximately 26 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Candesartan QD + Heart Failure Therapy | Experimental | Drug: Candesartan(with angiotensin-converting enzyme-inhibitors/beta-blockers) |
| Placebo QD + Heart Failure Therapy | Placebo comparator | Drug: Placebo(with angiotensin-converting enzyme-inhibitors/beta-blockers) |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diabetes mellitus type 2 - insulin dependent or orally treated or managed by diet for at least 3 Months.
- Normotension or controlled hypertension with sitting Systolic Blood Pressure less than 140 mmHg and/or sitting Diastolic Blood Pressure less than 90 mmHg.
- Regular sinus rhythm or atrial fibrillation with a medicamental-achieved rate control of less than 100 bpm as confirmed by electrocardiogram recordings.
- Echocardiographic evidence of a preserved Left Ventricular Ejection Fraction greater than or equal to 45% (assessed by the modified Simpson method), with further doppler-echocardiographic criteria for diastolic dysfunction grade I-IV.
- New York Heart Association classification of II or III in a stable condition since at least 3 months.
Key exclusion criteria (24 listed)
- Impaired renal function (serum creatinine greater than 2.2 mg/dl or greater than 194 μmol/l).
- Known bilateral renal artery stenosis or interventional treatment for renal artery stenosis in the last year.
- State after kidney transplantation.
- Serum potassium greater than 5.5 mmol/l or glycosylated hemoglobin greater than 9.5 %.
- Cor pulmonale or primary pulmonary disease with dyspnea at rest.
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 |
|---|---|---|
| CandesartanAlso: BLOPRESS®Candesartan up to 32 mg, tablets, orally, once daily and ongoing angiotensin-converting enzyme inhibitor/beta-blocker therapy for up to 24 weeks. | Drug | Candesartan QD + Heart Failure Therapy |
| PlaceboCandesartan matching-placebo tablets, orally, once daily and ongoing angiotensin-converting enzyme inhibitor/beta-blocker therapy for up to 24 weeks. | Drug | Placebo QD + Heart Failure Therapy |
Primary outcome
The change from Baseline in N-terminal pro-B-type Natriuretic Peptide biomarker.
Time frame: Week 24 or Final Visit.
22 secondary outcomes
Mean change in N-terminal pro-B-type Natriuretic Peptide (log-transformed).
Time frame: Weeks 6 and 24 or Final Visit.
Change from Baseline in Short Form-36 Health Survey score.
Time frame: Week 24 or Final Visit.
Change from Baseline in Cystatin C.
Time frame: Week 24 or Final Visit.
Change from Baseline in Adiponectin.
Time frame: Week 24 or Final Visit.
Change from Baseline in Glycosylated Hemoglobin.
Time frame: Week 24 or Final Visit.
Change from Baseline in Urinary Albumin Excretion.
Time frame: Week 24 or Final Visit.
Change from Baseline in estimated Glomerular Filtration Rate and Cystatin C.
Time frame: Week 24 or Final Visit.
Mean Change in New York Heart Association classification results.
Time frame: Week 24 or Final Visit.
Body Weight.
Time frame: Week 24 or Final Visit.
Blood Pressure.
Time frame: Week 24 or Final Visit.
Echocardiograms.
Time frame: Week 24 or Final Visit.
Correlations of N-terminal pro-B-type Natriuretic Peptide with New York Heart Association Classification Results.
Time frame: Week 24 or Final Visit.
Correlations of N-terminal pro-B-type Natriuretic Peptide with short Form-36 Health Survey Score.
Time frame: Week 24 or Final Visit.
Correlations of N-terminal pro-B-type Natriuretic Peptide with Blood Pressure Results.
Time frame: Week 24 or Final Visit.
Subgroup evaluations regarding beta-blocker therapy and New York Heart Association class (II/III).
Time frame: Week 24 or Final Visit.
Subgroup evaluations in terms of the different possible dosages of study medication.
Time frame: Weeks 6 to 24 or Final Visit.
Subgroup evaluations based on different baseline levels of estimated Glomerular Filtration Rate.
Time frame: Week 24 or Final Visit.
Subgroup evaluations based on different baseline levels of Cystatin C.
Time frame: Week 24 or Final Visit.
Subgroup evaluations based on different baseline levels of N-terminal pro-B-type Natriuretic Peptide.
Time frame: Week 24 or Final Visit.
Comparison from Baseline on the concomitant use of Loop Diuretics.
Time frame: Weeks 6 and 24 or Final Visit.
Transition from sinus rhythm to permanent atrial fibrillation based on electrocardiogram recordings.
Time frame: Week 24 or Final Visit.
Progression of preserved (Left Ventricular Ejection Fraction greater than or equal to 45%) to impaired systolic dysfunction (Left Ventricular Ejection Fraction less than 45%), based on echocardiographic results.
Time frame: Week 24 or Final Visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2010.
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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.
Medical Director study director
Takeda Pharma Gmbh, Aachen (Germany)
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Candesartan in people with Heart Failure, run by Takeda at 37 sites in Germany.
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 9 inclusion and 24 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: finished, as of the sponsor's last update on 22 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Germany. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The change from Baseline in N-terminal pro-B-type Natriuretic Peptide biomarker. (time frame: Week 24 or Final Visit.). 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 22 Jun 2010.