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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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25 November 2019 |
Main ID: |
EUCTR2006-001704-37-GB |
Date of registration:
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01/08/2007 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A 36 week, multicenter, randomized, double-blind, placebo- controlled, parallel-group study to evaluate the efficacy and safety of aliskiren on the prevention of left ventricular remodeling in high risk post-acute myocardial infarction patients when added to optimized standard therapy
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Scientific title:
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A 36 week, multicenter, randomized, double-blind, placebo- controlled, parallel-group study to evaluate the efficacy and safety of aliskiren on the prevention of left ventricular remodeling in high risk post-acute myocardial infarction patients when added to optimized standard therapy |
Date of first enrolment:
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07/11/2006 |
Target sample size:
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800 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-001704-37 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II):
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV):
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Countries of recruitment
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Belgium
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Czech Republic
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Denmark
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Germany
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Hungary
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Italy
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Netherlands
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Slovakia
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Sweden
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Male or female patients 18 years and older. 2. Patients within 7-42 days of an acute myocardial infarction associated with left ventricular systolic dysfunction prior to Visit 1 (see below). A qualifying myocardial infarction will require each of the following: • Typical clinical presentation consistent with myocardial infarction (i.e., chest pain, shortness of breath) • Elevation of cardiac markers (any of the following will fulfill the requirement for an increase in cardiac markers): • Both total CK and CK-MB are above the upper limit of normal (ULN) and either total CK or CK-MB are at least twice the upper limit of normal (2xULN) • CK-MB is elevated to at least twice the upper limit of normal (2xULN) when total CK is not available, and is confirmed by an accompanying Troponin T or I level at least three times the upper limit of normal (3xULN) • Total CK is elevated to at least twice the upper limit of normal (2xULN) when CK-MB is not available, or to above the ULN if confirmed by an accompanying Troponin T or I level at least three times the upper limit of normal (3xULN) • Troponin T or I level is at least five times the upper limit of normal (5xULN) and neither total CK nor CK-MB are available. • Typical ECG changes, including evolving ST-segment or T-wave changes in two or more contiguous ECG leads, the development of new pathological Q/QS waves in two or more contiguous ECG leads, or the development of new left bundle branch block. 3. Documented left ventricular systolic dysfunction associated with the qualifying acute myocardial infarction obtained as a clinical evaluation (study) post-MI but prior to Visit 1. Systolic dysfunction will be defined by at least one of the following criteria: • Echocardiography: LVEF <=45% • Radionuclide ventriculography: LVEF <= 45% • Ventricular contrast angiography: LVEF <= 40%. • Left Ventricular Wall Motion Index (LVWMI) > = 1.5
4. Patients should be on stable doses of the following standard of care post-MI concomitant medications for at least 2 weeks prior to Visit 1 unless contraindicated due to intolerance: • A Beta-blocker • An Anti-platelet agent • A Statin 5. Patients must be on a stable evidence-based dose (see Appendix3) of an Angiotensin Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) but not both. for at least 2 weeks prior to visit 1, unless contraindicated due to intolerance. For patients not on an evidence -based dose of an ACE1 or and ARB, the reason (e.g. patient intolerance of these medications) must be documented 6. Patients who are eligible, able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent). 7. Qualifying Echocardiogram: • Patients who fulfill the screening inclusion and
Exclusion criteria: For full list, please see protocol.
1. Patients requiring both ACEI and ARB combination therapy at V1 or any time during the study. 2. Hypertrophic cardiomyopathies due to etiologies other than hypertension (i.e., idiopathic or valvular). 3. Severe refractory hypertension defined as MSSBP = 180 mmHg and/or MSDBP = 110 mmHg) at Visit 2. 4. Hemodynamically significant stenotic or obstructive valvular, subvalvular or supravalvular lesions. 5. Secondary forms of cardiomyopathy such as restrictive cardiomyopathy or infective cardiomyopathy (e.g., Chagas’ disease). 6. Cardiogenic shock or systolic BP < 100 mmHg or diastolic BP <60mmHg within the 24 hours prior to Visit 1 or 2. 7. Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73m2 using the MDRD formula at Visit 1. 8. Stroke or transient ischemic event (TIA) within 6 months of Study Visit 1. 9. Serum potassium = 5.1 mEq/L, or dehydration at Study Visit 1. 10. Significant valvular cardiovascular disease expected to lead to cardiac surgery during the course of the study.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Post-acute myocardial infarction
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Intervention(s)
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Product Name: Aliskiren Product Code: SPP100A Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Aliskiren Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Product Name: Aliskiren Product Code: SPP100A Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Aliskiren Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): The primary efficacy variable is the change in left ventricular end systolic volume (LVESV) as assessed by echocardiography, from baseline to end of study.
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Main Objective: To demonstrate that aliskiren 300 mg, in addition to standard therapy, has superior efficacy compared to placebo in reducing the primary index of adverse cardiac remodeling (defined as the change in LVESV from baseline to end of study) in patients after high risk acute myocardial infarction.
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Secondary Objective: For full list, refer to protocol
To evaluate the effect of aliskiren compared to placebo on: • a composite outcome of CV death, hospitalization for heart failure, or a reduction in left ventricular ejection fraction greater than 6 units (absolute percentage points) • a composite outcome of time to CV death, hospitalization for heart failure, recurrent myocardial infarction, stroke or resuscitated sudden death • change in left ventricular ejection fraction (LVEF) between baseline and end of study Exploratory Objectives: To evaluate the effect of aliskiren compared to placebo on: • renal function as measured by change in estimated glomerular filtration rate (eGFR), cystatin C, and urinary albumin creatinine ration (uacr) from baseline to end of study (in a subset of patients) • other biological markers relevant to the pathophysiology of remodeling and other outcomes after myocardial infarction (in a subset of patients)
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Secondary ID(s)
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2006-001704-37-NL
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CSPP100A2340
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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