Effects of Pioglitazone in Combination with Atorvastatin in Comparison to Atorvastatin treatment alone on Intima-Media Thickness in patients at Risk for Vascular Complications
- Conditions
- Patients at risk for vascular complications (cardiovascular anamnesis, hypertension, hypercholesterolemia) and a carotid intima media thickness >= 0.8 mm at least at one side will be eligible for the study
- Registration Number
- EUCTR2004-004463-30-DE
- Lead Sponsor
- Takeda Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
Patients with proven cardiovascular diseases, Carotid intima media thickness >= 0.8 mm, Male or female aged 30 to 70 years, Body Mass Index >= 25 kg/m², Patients having signed written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
History of overt type-2-diabetes according to the WHO criteria, History of Type 1 diabetes, History of more than one unexplained hypoglycaemic episode within the last 6 months, Statine therapy within the last 4 weeks, Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures, History of severe or multiple allergies, Treatment with any other investigational drug within 3 months before trial entry, Progressive fatal disease, Myopathy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the influence of the combination of Pioglitazone plus Atorvastatin in comparison to Atorvastatin therapy alone over 25-weeks on carotid intima media thickness;Secondary Objective: To investigate the effect on the several other parameters, like hs CRP, IL-6, Plasma glucose, HbA1c, Insulin, Intact proinsulin, Adiponectin, MCP-1, MMP-9, SCD 40, etc.<br>;Primary end point(s): The primary efficacy variable will be the change of intima media thickness after 24 weeks of treatment. The change will be calculated as the intima media thickness at the screening visit (visit 1; day 0) minus the intima media thickness at the end of the study (visit 5; week 24±2).
- Secondary Outcome Measures
Name Time Method