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. MedDRA version: 12.1 Level: LLT Classification code 100
Conditions
Interventions
Trade Name: Ulgixal
Product Name: pemirolast
Pharmaceutical Form: Tablet
INN or Proposed INN: pemirolast
Current Sponsor code: CDZ_PE
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
Cardoz AB
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of pemirolast on C-reactive protein levels. ;Secondary Objective: To determine the safety and tolerability of pemirolast administration ;Primary end point(s): Change in hs-CRP during the treatment period. | — |
Countries
Sweden
Outcome results
None listed