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Clinical trial summary
We are conducting a clinical trial for a potential new medicine that could be used to treat people with hypertension (high blood pressure) aged 18 years or older. We will look at how safe and effective the study medication is in lowering blood pressure in patients with hypertension when given to patients on at least 2 blood pressure-lowering medications and are at an increased risk for experiencing a cardiovascular event.
You will be reimbursed for your time if you take part in this clinical trial.
If you are interested in participating in this trial:-
- You will need to attend a screening appointment so we can check if you are suitable to take part in the trial. At this appointment, we will perform a number of tests, including taking blood samples, checking your blood pressure and carrying out a physical examination.
- The screening appointment may be conducted over several days.
- If results from your screening appointment show you are suitable for the trial, you will be invited to take part.
- On ‘Day 1’ of the trial, you will be randomly assigned to receive either the study medicine or placebo (inactive substance that looks the same and is given the same way as an active medication) via a subcutaneous injection (under the skin).
- After your visit with us you will be required to return for further 4 appointments at Month 1, Month 2, Month 3, and Month 6 of the trial.
- There are follow-up visits at Month 9 (telephone call only) and Month 12 (in-person clinic visit).
- This means the whole process takes approximately 14 months from the screening visit to the final follow-up visit.
- In total, if you are included in the clinical trial you will come to the clinic for 7 scheduled appointments.
- During the trial, you will receive a single dose of the study medicine (or placebo), and we will conduct a number of assessments (like those we did at screening) to check how effective and safe the potential new medicine is in patients with high blood pressure who may be at a higher risk for experiencing a cardiovascular event.
Who can take part?
We will check your suitability for the clinical trial using the following criteria:-
- You are a male or female aged 18 years or older.
- You have a history or high risk of cardiovascular disease as previously documented or assessed at Screening.
- You are being treated for hypertension on stable therapy with 2 to 4 anti-hypertensive medications.
- You must not have secondary hypertension.
- You must not have a known active human immunodeficiency virus (HIV), or known or current or chronic hepatitis B or C virus infection.
- You must not have received an investigational drug within the last 30 days prior to dosing.
- You must not have a history of alcohol abuse or dependency within 12 months before screening.
- You must not be a night shift or 24-hour shift worker.
- If you are a female, you must not be pregnant, planning a pregnancy or breastfeeding.
- If you are a female, you must be willing to comply with the contraceptive requirements during the trial.
A full list of do’s and don’ts will be given to you by a member of our recruitment team if you are interested.
Clinical trial payment
In recognition of the time involved in taking part in the trial, you will be reimbursed up to £1,233 (£822 clinical trial payment and £411 bonus for compliance) on completion of the clinical trial, provided you comply fully with all the clinical trial requirements. This amount is based on the anticipated clinical trial plan and will be adjusted pro-rata (i.e. same amount of money paid per unit of time), should we invite you to attend extra visits.
Clinical trial dates
Admission: October
Follow-up visits: November, December 2024 January, April and October 2025.
Please call a member of the recruitment team on 0207 042 5800 to discuss alternative study dates.
Approval
The contents of this email have been approved by an ethics committee. Any response to this advertisement will be recorded. Your response will not place you under any obligation to participate in this trial.
You may be required to remain resident in the unit until resolution of any safety issues, after which you will be discharged from the unit.
Ref: C24009_MAY_2024 (email_website_advert text)
