E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
SUSPECTED PULMONARY EMBOLI AND/OR DEEP VENOUS THROMBOSIS MedDRA code for deep venous thrombosis: version 7 LLT 0.913 |
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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 |
To compare the efficacy of two concentrations of Iomeron (300 mgI/mL and 400 mgI/mL) in multislice CT angiography (MS-CTA) of the pulmonary arteries in terms of attenuation values (HU), measured at different levels of the pulmonary arteries (main pulmonary artery, right and left pulmonary arteries, lobar arteries, and selected segmental arteries). |
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E.2.2 | Secondary objectives of the trial |
Quantitative
Comparison of the two study groups for: 1. lesion contrast for pulmonary emboli (if applicable) 2. attenuation values (HU) in MS-CT-phlebography (MS-CTP) of the major deep venous system of the lower extremities (from the popliteal veins to the infrarenal portion of the inferior vena cava) 3. lesion contrast for deep venous thrombi (if applicable)
Qualitative
Comparison of the two study groups for: 1. the presence of artefacts due to the contrast agent 2. the quality of enhancement and visualization of the pulmonary arteries in MS-CTA 3. the quality of enhancement and visualization of the lower extremity veins in MS-CTP 1. the safety of the two Iomeron concentrations
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Are at least 40 years of age 2. With suspected pulmonary embolism, 3. Referred for a MS-CTA examination of the pulmonary arteries, 4. Provide written Informed Consent and are willing to comply with protocol requirements
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E.4 | Principal exclusion criteria |
1. patients with a history of hypersensitivity to iodine-containing compounds, 2. patients with severe congestive heart failure (class III and IV according to NYHA classification), 3. patients with a severe renal failure (serum creatinine > 2.5 mg/mL), 4. patients having undergone any other radiological procedure utilising x-ray contrast media during the 24 hour period preceding multislice, spiral, computed tomography, 5. Is a pregnant or lactating female. Exclude the possibility of pregnancy: - by testing on site at the institution (serum or urine βHCG) within 1 hour prior to the start of study agent administration - by questioning the patient - by history (e.g., tubal ligation or hysterectomy) - post-menopausal with a minimum 1 year without menses. 6. Has received an investigational compound within 30 days before admission into this study, 7. Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations, 8. Is determined by clinical physician and/or the Investigator that the subject is clinically unsuitable for the study,
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E.5 End points |
E.5.1 | Primary end point(s) | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
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 | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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 | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
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 | Information not present in EudraCT |
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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THE LAST VISIT OF THE LAST PATIENT ENROLLED IN THE TRIAL |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |