E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 |
This is a feasibility study, which serves as a prelude to a definitive randomised controlled trial to determine whether the treatment of WCH in the very elderly outweighs any adverse events. The primary research question is: Will it be feasible to conduct a study treating WCH in a cohort of older people? To answer the above question, this feasibility study will focus on the following outcomes: 1. The proportion of eligible patients that can be recruited from initial screening 2. An exploration of different methods of identifying/recruiting patients including preliminary experience using the National Institute for Health Research/Clinical Research Network recruitment methods 3. The willingness of GPs to recruit and randomise patients 4. The willingness of patients to be randomised 5. Recruitment rate 6. Adherence to the treatment protocol 7. Withdrawal from the clinical trial 8. Expanding the opportunities for PPI (patient and public involvement) in the research design and its subseque |
|
E.2.2 | Secondary objectives of the trial |
As this is a feasibility trial there are no secondary objectives |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients ≥75 years of age • Clinic sitting systolic BP ≥150mmHg but <200mmHg and diastolic BP <110mmHg • Diagnosis of white coat hypertension at baseline if the mean ambulatory day time average systolic BP is <135 mmHg and diastolic BP is <85mmHg (from at least 14 measurements) or for HBPM from BP readings twice a day for at least 5 days (ideally 7 days)at baseline • Not taken antihypertensive drug therapy within the last 6 months • Capacity to consent • Provision of documented informed consent • Ability to comply with the protocol and additional study visits & assessments
|
|
E.4 | Principal exclusion criteria |
• Contraindication to the use of indapamide MR and perindopril in accordance with the summary of product characteristics • Regular non-steroidal anti-inflammatory drug (NSAID) use. Regular use being defined by the local GP with consideration to cardiovascular risk and blood pressure • Hypertensive emergency • Secondary hypertension • Postural hypotension (postural drop in systolic BP≥20mmHg or postural symptoms at screening) • Any stroke or myocardial infarction in the previous 6 months • Heart failure requiring treatment with drugs having an antihypertensive effect • Previous documented evidence of gout • eGFR less than 30ml/min • Montreal cognitive assessment score (MoCA) < 22 • Life expectancy <1year due to malignancy or chronic disease
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
This is a feasibility study, which serves as a prelude to a definitive randomised controlled trial, in order to determine whether the treatment of WCH in the very elderly is feasible and outweighs any adverse events. This feasibility study will focus on the following outcomes: 1. The proportion of eligible patients that can be recruited from initial screening 2. An exploration of different methods of identifying/recruiting patients including preliminary experience using the National Institute for Health Research/Clinical Research Network recruitment methods 3. The willingness of GPs to recruit and randomise patients 4. The willingness of patients to be randomised 5. Recruitment rate 6. Adherence to the treatment protocol 7. Withdrawal from the clinical trial 8. Expanding the opportunities for PPI (patient and public involvement) in the research design and its subsequent conduct and dissemination 9. Estimate the incidence of Cardiovascular Events 10. measure ambulatory and home blood pressure
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
By the end of the study, its feasibility will be ascertained through answering the above questions. |
|
E.5.2 | Secondary end point(s) |
As this is a feasibility study there are no secondary end points |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | 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 | 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 | Yes |
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 |
|
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 36 |
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
|
Last Post Treatment Follow Up contact with participants GP |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 1 |