Randomized, placebo-controlled, double-blinded study evaluating the effects of Pioglitazone on intima-media-thickness (IMT) of the carotid arteries measured by MRI in non-diabetic patients with confirmed arteriosclerosis

• Conditions: Male or female non-diabetic patients at an age between 30 and 79 years (inclusive) with a proven vascular disease defined as arteriosclerosis confirmed by presence of CAD, PAD or carotid plaques.

• Registration Number: EUCTR2006-000171-15-DE
• Lead Sponsor: niversity Hospital of Ulm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-05
• Last Update Posted: 10 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Male or female patient at an age between 30 and 79 years (inclusive); the patient has a proven vascular disease defined as arteriosclerosis confirmed by the presence of CAD or PAD or carotid plaques; normal HbA1c (< 6%) plus normal fasting blood glucose (< 126 mg/dl) for 2 days prior to randomization (according to pre-study routine laboratory investigations); negative pregnancy test on Study Day 0 (Visit 1) in women with childbearing potential; signed and dated 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

Hemodynamic unstable patient or unstable acute coronary syndrome or state after acute myocardial infarction = 4 days; History of diabetes mellitus (any type 1 or 2); History of heart failure (NYHA I-IV) or relevant respiratory, renal (creatinine > 2.0 mg/dl), gastrointestinal or hematological diseases; History of renal failure requiring hemodialysis; Inadequate hepatic function (AST and ALT > 2.5 x ULN) ; History of severe/multiple allergies or systemic inflammatory diseases; History of any cancer disease or any cancer treatment in the last 5 years (exception: non-metastasizing skin cancer); Known/suspected hypersensitivity to pioglitazone or other TZDs; Pre- treatment with TZDs during 3 months prior to study enrolment; Severe claustro-phobia and/or MR-incompatible implants, and/or large sized coloured tattoos; Drug/alcohol abuse in the last 5 years; Blood donation in the last 30 days; Pregnant or nursing woman, or woman of childbearing potential not using effective contraceptive methods during the study (medications, patches, condoms, IUDs, male partner sterilization); Any further condition which according to the investigator results in an undue risk to the patient during participating in the present study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified