E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with adult-onset growth hormone deficiency and the presence of atherosclerotic disease in the coronary arteries |
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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 |
Hypothesis:
1. Patients who suffer from a hypopituitarism and an adult-onset growth hormone deficiency (AGHD) express more atherosclerotic disease in the coronary system (compared with a historically formed control subjects, present as a database in the cardiology department from the UMC Utrecht) 2. Atherosclerotic disease in the coronary system wil be in regression after one year substitution with recombinant human growth hormone (in line with previously published results with regard to carotid IMT)
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E.2.2 | Secondary objectives of the trial |
Patients with a hypopituitarism and AGHD display additional proatherogenic mechanisms: 2.1 disturbances in antioxidant capacity of the high-density lipoprotein (HDL) fraction, 2.2 disturbances in the differentiation of endothelial progenitor cells with a less capacity to repair damaged endothelium, 2.3 an increase of metalloproteinases as part of the pro-inflammatory profile in circulation . |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Biochemically proven GH deficiency 2. Age between 35 and 60 years 3. GH deficient within half a year of neurosurgical procedure or GH deficient at least 5 years 4. Optimal substitution of other hormones |
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E.4 | Principal exclusion criteria |
1. BMI >30 2. Positive history of myocardial or valve or coronary disease or symptoms that suggest coronary disease (chest pain in rest or during exercise) 3. Rhythm disturbances 4. Moderate or severe pulmonary disease 5. Impairment in renal function (Creatinin clearance < 60 ml/min) 6. Positive family history of primary dyslipidemia 7. Positive family history from premature cardiovascular disease 8. Positive family history of diabetes type II 9. Allergy for contrast 10. Claustrophobia |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Presence of atherosclerotic disease in the coronary system (scored in an established (blinded) protocol as the level of stenosis within coronary segments and the level of intracoronary calcium)
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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 | 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 | 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) | 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 | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | 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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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 | 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 | 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 in the protocol after 12 months GH substitution |
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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 |