E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cardoz AB intends to develope pemirolast as an anti-inflammatory agent. The first intended indication for the product under development is abdominal aortic aneurysm. The proposed clinical study will explore the effects of pemirolast on C-reactive protein levels. An effect on inflammation measured as hsCRP would be very important for reducing risk for cardiac infarction, stroke and cardiovascular death and also for onset of type 2 diabetes. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000054 |
E.1.2 | Term | Abdominal aortic aneurysm |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the effects of pemirolast on C-reactive protein levels.
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E.2.2 | Secondary objectives of the trial |
To determine the safety and tolerability of pemirolast administration |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects with coronary artery disease (CAD): a)CAD (diagnosed on the basis of a previous myocardial perfusion study or cardiac catheterisation, or a history of myocardial infarction or coronary angioplasty or coronary artery bypass surgery). b)Male or female subjects aged 40 – 70 years. Body Mass Index between 19 and 29 kg/m2 c)Stable statin therapy since one month. d)High sensitivity CRP (hs-CRP) >2.0 and <10.0 mg/L. e)No change in cardiac medications since one month. f)Female subjects have to be non-fertile, i.e. postmenopausal or surgically sterile. g)In the opinion of the Investigator, the subject will be able to comply with the requirements of the protocol. h)Subjects will have given their written informed consent to participate in the study.
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E.4 | Principal exclusion criteria |
Subjects with CAD: a)Acute illness within the last two weeks. b)Pharmacologically treated type 1 or type 2 diabetes mellitus. c) Recent coronary events (within 3 months) d)Clinical heart failure e)Subjects with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiac, pulmonary, metabolic, endocrine, haematological, psychological or other major disorder as judged by the Investigator. f)Pregnancy or breast feeding g)Subjects who previously have demonstrated hypersensitivity to the investigational medicinal product. h)Subjects atopic or with history of allergy as judged by the Investigator. i)Subjects who have used any prescribed systemic, except prescribed statin and cardiovascular medications (beta blockers, calcium inhibitors, ACE-inhibitors, diuretics, clopidogrel (Plavix) and low dose trombyl) or topical medication within 14 days before the first dose administration. j)Subjects who have used any OTC systemic or topical medication within 7 days before the first dose administration (with the exception of vitamin/mineral supplements, paracetamol, NSAIDs or nasal decongestants at the discretion of the Investigator). k)Subjects who have participated in a clinical study involving administration of an investigational drug or a marketed drug within the past 3 months. l)Subjects who have donated blood during the last 3 months or plasma the last month. m)Subjects who have had a clinically significant illness within 4 weeks of the start of the study as judged by the Investigator. n)Subjects who are known to have serum hepatitis or who are carriers of the hepatitis B surface antigen (HBsAg), or hepatitis C antibody, or have a positive result to the test for HIV antigens and/or antibodies. o)Heavy smoker and/or excessive use of alcohol, as judged by the Investigator.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in hs-CRP during the treatment period. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is when the last assessments have been performed for the last subject. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |