E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteer trial in obese subjects (body mass index 30 or greater) in which the IMP will be used to reduce inflammation by inhibiting tumour necrosis factor(TNF)-α in order to assess the effects on vascular function. |
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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 |
Does reducing inflammation in obese volunteers, using pentoxifylline, lead to an improvement in the health of blood vessels?
We will measure the health of blood vessels by taking blood samples and carrying out an ultrasound scan of the blood vessel in the arm before and after treatment.
This will address whether inflammation causes 'unhealthy' blood vessels in people with obesity. |
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E.2.2 | Secondary objectives of the trial |
Does reducing inflammation in obese volunteers, using the drug pentoxifylline, alter markers of blood vessel damage and repair in the blood?
Everyone has small numbers of endothelial microparticles (tiny fragments of cells lining blood vessels) and endothelial progenitor cells (cells which come from the bone marrow and help to repair blood vessels)in their blood stream. Measuring the relative numbers of endothelial microparticles and endothelial progenitor cells in the blood stream gives an indication of how healthy the blood vessels are.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
age 18-65 obesity (Body Mass Index 30 or greater) not taking other medication (apart from oral contraceptives)
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E.4 | Principal exclusion criteria |
diabetes hypertension hyperlipidaemia cardiovascular disease or history of cardiac arrythmias chronic inflammatory disorders (e.g. rheumatoid arthritis, connective tissue disorders, gout, inflammatory bowel disease, chronic infections) acute inflammatory illnesses (e.g. upper respiratory tract infections) allergy to pentoxifylline or other methyl xanthine drugs or concomitant use of sildenafil, tadalafil, vardenafil or other phosphodiesterase 5 inhibitors history of cerebral haemorrhage or retinal haemorrhage pregnancy or breastfeeding Impaired renal function Hypotension (systolic blood pressure less than 90mmHg)
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E.5 End points |
E.5.1 | Primary end point(s) |
Flow-mediated dilatation (FMD) of the brachial artery |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Mechanistic (basic scientific) research |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
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 | 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 participant 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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |