E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
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 |
Exploration of possible differences in the effect on IMT (as the total vessel wall volume in MRI) of an add-on-therapy with pioglitazone versus placebo in non-diabetic patients with confirmed arteriosclerosis in order to gain more detailed information and to generate valid hypotheses for further project planning. |
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E.2.2 | Secondary objectives of the trial |
Evaluation of relevant further efficacy, safety and tolerability parameters considering IMT-measurements, MR-angiography (patient subgroup), laboratory variables, vital signs and adverse events in non-diabetic patients with confirmed arteriosclerosis under add-on-therapy with pioglitazone compared to placebo. In a selected subgroup of study patients defined as patients with proven significant (>50% stenosis) proximal coronary artery disease without ischemia (no invasive treatment with PTCA or stenting), a visualization of the coronary vessel status (MRI assessment of the vessel lumen and the vessel wall thickness) will be performed additionally by specific MR-angiography. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Analysis of the total vessel wall volume of the carotid bulbus/bifurcation (CB) determined with MRI after 24 months of study treatment compared to baseline (Visit 2; Day 1) |
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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 | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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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Last visit of last patient (LPO) |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |