E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes mellitus Hypertension |
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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 |
Analysis of the shape of pressure waves in arteries permits the detection of abnormalities in the circulation. Such changes have been shown to predict future complications in patients with diabetes mellitus or high blood pressure (hypertension). We plan to study the shape of pressure waves in various arteries around the body using an ultrasound scanner. We will investigate whether abnormalities are generalisable, or whether they are confined to particular organ beds. |
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E.2.2 | Secondary objectives of the trial |
We also plan to investigate the effects of the drug ramipril on arterial waveshape. Comparison with the effects of another drug, bendroflumethiazide, will separate out blood-pressure lowering effects from other actions of the drug.
We also aim to relate change in the ultrasound signal from the central retinal artery to changes in shape and size of the blood vessels at the back of the eye in response to inhaling oxygen and carbon dioxide. This can be done by taking photographs of the back of the eye. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Participants with diabetes
- Type 1 diabetes - Age between 18 and 55 years
Participants with hypertension
- Systolic blood pressure greater than or equal to 140 mmHg, and/or diastolic blood pressure greater than or equal to 90 mmHg - Age between 18 and 55 years
Control subjects
- Age and sex matched controls to the above participants
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E.4 | Principal exclusion criteria |
Participants with diabetes
- Known coronary, cerebrovasular, peripheral vascular or reno-vascular disease - HbA1C greater than or equal to 10% (a blood test indicating degree of control of diabetes) - On 2 or more medications for hypertension or diabetic renal disease - Proliferative retinopathy - Past or present retinal laser treatment - Systolic blood pressure greater than 140 or less than 110 mmHg - Diastolic blood pressure greater than 90 or less than 60 mmHg - Total cholesterol greater than 6.0 mmol/l - LDL cholesterol greater than 3.0 mmol/l - Estimated glomerular filtration rate less than 60 ml/min/1.73m2 - Pregnancy or breast feeding - Electrolyte or significant liver function abnormalities - Known hypersensitivity to ACE inhibitors - Any significant other medical illness
Hypertension
- Known coronary, cerebrovasular, peripheral vascular or reno-vascular disease - Random venous glucose greater than 6.1 mmol/l - Diabetes mellitus - On 2 or more medications for hypertension - Systolic blood pressure greater than or equal to 160 mmHg or Diastolic blood pressure greater than or equal to 100 mmHg if on no anti-hypertensive therapy - Systolic blood pressure greater than or equal to 150 mmHg or Diastolic blood pressure greater than or equal to 90 mmHg if on anti-hypertensive therapy - Total cholesterol greater than 6.0 mmol/l - LDL cholesterol greater than 3.0 mmol/l - Estimated glomerular filtration rate less than 60 ml/min/1.73m2 - Pregnancy or breast feeding - Electrolyte or significant liver function abnormalities - Known hypersensitivity to ACE inhibitors - Any significant other medical illness
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E.5 End points |
E.5.1 | Primary end point(s) |
Waveform recordings taken from the brachial, ophthalmic, central retinal, carotid and renal arteries.
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | 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 | 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) | Yes |
E.8.2.2 | Placebo | No |
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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The last visit of the last subject undergoing 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 |
E.8.9.2 | In all countries concerned by the trial days | 0 |