Effects of Pioglitazone in Combination with Atorvastatin in Comparison to Atorvastatin treatment alone on Intima-Media Thickness in patients at Risk for Vascular Complications

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004463-30-DE

Enrollment

160

Registered

2005-04-21

Start date

2005-06-22

Completion date

Unknown

Last updated

2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Actos 15mg Tablets Actos 30mg Tablets Product Name: Actos 45mg Pharmaceutical Form: Capsule* INN or Proposed INN: Pioglitazone HCl Concentration unit: mg milligram(s) Concentration type: e

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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. ;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).	—

Measure

Time frame

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. ;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).

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026