E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hypertension Cardiovascular disease |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
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 |
Our primary objective is to determine if there is a difference in the AUC of losartan and perindopril when comparing elderly (>70 years) with younger patients (<50 years). |
|
E.2.2 | Secondary objectives of the trial |
To determine:
- if there is a difference in the drop of blood pressure in respons to losartan or perindopril between older (>70 years) and younger (<50 years) patients; and if so, can this difference be explained by a difference in the plasma concentration of the drug - parameters that are of influence on the AUC other than age. - Influence of age and the AUC of perindopril and losartan on RAAS-activity |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients can participate in this study if they meet all of the following criteria: • Age between 18-50 years or > 70 years • Start with the use of oral perindopril 2, 4 or 8 mg a day or losartan 25, 50 or 100 mg a day OR already use perindopril 2, 4 or 8 mg a day or losartan 25, 50 or 100 mg a day • Providing informed consent after reading the patient information
|
|
E.4 | Principal exclusion criteria |
Patient are excluded from participation in this study if they meet the following criteria: • Not providing informed consent or not capable of giving informed consent, • End-stage renal disease (eGFR<15 ml/min), • Use of other antihypertensive drugs prescribed to reduce blood pressure including diuretics, dihydropyridine calcium blockers, beta blockers with the exception of sotalol, doxazosin, or other RAAS-inhibitors
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The main study parameters are the AUC-measurements of perindopril and losartan in the elderly (> 70 years) and young patients (< 50 years) during 24 hours. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
First evaluation of end point will take place when half (40 subjects) of the subjects have been included
Final evaluation of end point will take place after last subject has completed the last visit. |
|
E.5.2 | Secondary end point(s) |
The blood pressure results in the elderly (> 70 years) and young patients (< 50 years) during 24 hours. Furthermore, we want to determine if there is a relationship between the AUC of these antihypertensive drugs and the drop in blood pressure. When patients have to take a venipuncture for clinical use, the rest material will be sampled.
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
First evaluation of secondary end points will take place when half (40 subjects) of the subjects have been included
Final evaluation of secondary end points will take place after last subject has completed the last visit. |
|
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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
prospective observational study |
|
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 | 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 | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |