A Single-blind Pilot Study to Investigate Safety and Tolerability of the Chymase Inhibitor BAY1142524 in Clinically Stable Patients With Left-ventricular Dysfunction
NCT ID: NCT02452515
Last Updated: 2017-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
49 participants
INTERVENTIONAL
2015-07-31
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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BAY1142524 (5 mg)
12 patients with left-ventricular dysfunction after myocardial infarction, 9 patients allocated to verum treatment, 3 patients allocated to placebo treatment
BAY1142524
5 mg BAY1142524 or placebo given as 5 mg IR tablet twice daily for 2 weeks
Placebo
The patients will be treated orally with combinations of IR tablets containing placebo to achieve the indicated dosages.
BAY1142524 (10 mg)
12 patients with left-ventricular dysfunction after myocardial infarction, 9 patients allocated to verum treatment, 3 patients allocated to placebo treatment
BAY1142524
10 mg BAY1142524 or placebo given as 2 x 5 mg IR tablets twice daily as for 2 weeks
Placebo
The patients will be treated orally with combinations of IR tablets containing placebo to achieve the indicated dosages.
BAY1142524 (25 mg)
12 patients with left-ventricular dysfunction after myocardial infarction, 9 patients allocated to verum treatment, 3 patients allocated to placebo treatment
BAY1142524
25 mg BAY1142524 or placebo given as 5 x 5 mg IR tablets twice daily for 2 weeks
Placebo
The patients will be treated orally with combinations of IR tablets containing placebo to achieve the indicated dosages.
BAY1142524 (50 mg)
12 patients with left-ventricular dysfunction after myocardial infarction, 9 patients allocated to verum treatment, 3 patients allocated to placebo treatment
BAY1142524
50 mg BAY1142524 or placebo given 1 x 50 mg IR tablet once daily for 2 weeks
Placebo
The patients will be treated orally with combinations of IR tablets containing placebo to achieve the indicated dosages.
Interventions
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BAY1142524
5 mg BAY1142524 or placebo given as 5 mg IR tablet twice daily for 2 weeks
BAY1142524
10 mg BAY1142524 or placebo given as 2 x 5 mg IR tablets twice daily as for 2 weeks
BAY1142524
25 mg BAY1142524 or placebo given as 5 x 5 mg IR tablets twice daily for 2 weeks
BAY1142524
50 mg BAY1142524 or placebo given 1 x 50 mg IR tablet once daily for 2 weeks
Placebo
The patients will be treated orally with combinations of IR tablets containing placebo to achieve the indicated dosages.
Eligibility Criteria
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Inclusion Criteria
* New York Heart Association (NYHA) class I-II.
* Left-ventricular ejection fraction ≤ 45%, confirmed by any imaging technique within the last 3 months prior to screening visit will be accepted for screening purposes. If no data are available, an echocardiography has to be performed at screening for inclusion.
* Treatment with evidence-based therapy for left-ventricular dysfunction post MI for at least 4 weeks prior to screening visit. This therapy has to include at least an Angiotensin-converting enzyme (ACE) inhibitor or an Angiotensin receptor blockers (ARB). Beta-blockers, diuretics, mineralocorticoid receptor antagonist (MRAs), antiplatelet therapy, statins, and aspirin are to be used if indicated. Treatment with stable doses of ACE inhibitors or ARBs using at least half of the recommended target dose (as defined in the European Society of Cardiology (ESC) guidelines, see appendix 16.4) ≥ 4 weeks prior to the screening visit is mandatory.
* No planned changes to post MI drug therapy during the active treatment phase of the study.
* Men or confirmed postmenopausal women (defined as being amenorrheic for longer than 2 years with an appropriate clinical profile, e.g. age appropriate and a history of vasomotor symptoms) or women without childbearing potential based on surgical treatment such as bilateral tubal ligation, bilateral oophorectomy or hysterectomy (documented by medical report verification).
Men of reproductive potential must agree to use 2 reliable and acceptable methods for contraception simultaneously when sexually active and not to act as sperm donor. This applies for the time period between signing of the informed consent form and 12 weeks after the last administration of study drug.
Acceptable methods of contraception include, but are not limited to, (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device; (iv) hormone-based contraception.
* Age: 40 to 79 years (inclusive) at the screening visit.
* Race: Caucasian
Exclusion Criteria
* Hospitalization for decompensated heart failure within the last 3 months prior to randomization.
* Coronary revascularization within 6 weeks prior to randomization or if revascularization is anticipated or needed during the study duration.
* Clinically relevant, cardiac ischemia in a stress test within 3 months before screening.
* Patients carrying implantable cardioverter defibrillators, cardiac resynchronisation therapy devices or left ventricular assist devices that had any significant clinical events requiring treatment or changes to background medical therapy such as ventricular tachycardias, ventricular fibrillation in the last 6 months before randomization while carrying the devices
* Primary and uncorrected valvular disease with foreseen requirement of valve repair within the next 6 months.
* Any stroke, TIA, any acute coronary syndrome within 6 months prior to randomization.
* Clinically relevant hepatic dysfunction at the screening visit indicated by at least one of the following:
* hepatic insufficiency (Child-Pugh B or C) as documented in medical history
* total bilirubin \> 2 times the upper limit normal (ULN) and
* alanine amino transferase (ALT) \> 3 times the ULN or
* glutamate dehydrogenase (GLDH) \> 3 times the ULN or
* gamma glutamyl transpeptidase (GGT) \> 5 times the ULN.
* Systolic blood pressure below 100 or above 160 mm Hg at the screening visit based on the average of 3 readings taken from the arm with the highest recordings.
40 Years
79 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Copenhagen, , Denmark
Copenhagen Ø, , Denmark
Hellerup, , Denmark
Herlev, , Denmark
Frankfurt am Main, Hesse, Germany
Düsseldorf, North Rhine-Westphalia, Germany
Erfurt, Thuringia, Germany
Berlin, , Germany
Bergamo, Lombardy, Italy
Brescia, Lombardy, Italy
Countries
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Other Identifiers
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2014-005297-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17055
Identifier Type: -
Identifier Source: org_study_id