Phase 2 Hypertension Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have given written agreement to participate before any study procedures begin
• People aged 18 to 70 years old at the time of their screening visit
• People with high blood pressure that is not well controlled, even though they are already taking at least 2 different types of blood pressure medications (from approved drug classes) at a stable dose for at least 30 days before screening — a combination pill counting as two medications qualifies
• People whose average blood pressure reading is 130/80 mmHg or higher (this threshold may be raised during the trial after the first 80 participants are enrolled)
• Men, or women who are not pregnant and not breastfeeding — women must either be naturally past menopause (no periods for at least 1 year, confirmed by a hormone test), have had a surgical procedure making pregnancy impossible, or be willing to use 2 approved methods of contraception throughout the study and for at least 30 days after the last dose (acceptable methods include hormonal contraceptives started at least 30 days before the first dose, an intrauterine device, barrier methods with spermicide, a vasectomised sole partner, or consistent abstinence as a usual lifestyle choice — periodic or withdrawal methods are not accepted)
• People with a body mass index (a measure of weight relative to height) between 18 and 35
• People whose urine drug screen before the study is negative (a positive result for cannabis alone does not automatically disqualify someone)
• People who take a PDE5 inhibitor medication (a type of drug used for erectile dysfunction) and are willing to pause its use for the duration of the study

Who may not be able to join:

• People currently enrolled in another clinical trial or medical research study within 30 days before being randomly assigned to a treatment group
• People whose blood pressure reading is above 170 mmHg (top number) and/or above 110 mmHg (bottom number)
• People currently using, or planning to use, nitrates, alpha-blockers, SGLT2 inhibitors, GLP-1 agonists, or other medications known to affect blood pressure during the study (except those specifically permitted by the trial protocol)
• People who regularly use PDE5 inhibitor medications and are unable or unwilling to stop using them for at least 7 days before and throughout their time in the study
• People with a history of low blood pressure, fainting, blackouts, or a condition where blood pressure drops when standing up
• People with severe or hard-to-control high blood pressure caused by specific underlying conditions, such as a hormone-producing tumour (primary aldosteronism) or another identifiable medical cause (secondary hypertension)
• People with active inflammation of the pancreas (pancreatitis)
• People with a history of drug abuse
• People who drink alcohol heavily — defined as more than 21 standard drinks per week for men, or more than 14 standard drinks per week for women (where one standard drink equals a 12 oz beer, one measure of spirits, or one glass of wine)
• People with a known history or current condition affecting the stomach, intestines, liver, or kidneys in a way that could interfere with how the body processes medications
• People who have had a heart attack, unstable chest pain requiring hospitalisation, coronary bypass surgery, a procedure to open blocked heart arteries, carotid artery surgery or stenting, a stroke, a mini-stroke, or a procedure for blocked leg arteries within the 3 months before screening — or who are planning any major surgery or procedure during the study period (people with a pacemaker or implanted heart device may be considered if the trial investigator determines they have been stable for at least 3 months)
• People with an underactive thyroid that is not well controlled (confirmed with a specific blood test result); people who have been on stable thyroid replacement medication for at least 6 weeks before randomisation may be considered
• People with liver disease, a positive test for hepatitis B surface antigen or hepatitis C antibodies, or certain abnormal liver blood test results at screening (specific exceptions may apply — the trial site can clarify)
• People whose kidneys are not filtering blood adequately, based on a specific calculation using a blood test result (confirm with trial site for exact threshold)
• People with stomach or intestinal conditions, or who have had weight loss surgery (such as gastric bypass or lap-band), that could affect how the body absorbs medication
• People with blood disorders, clotting problems, or a haemoglobin level (a measure of red blood cell health) below 10.0 g/dL at screening
• People with an active cancer diagnosis, or who have required surgery, chemotherapy, or radiation for cancer within the past 5 years (certain non-spreading skin cancers and early-stage cervical changes may be allowed — confirm with trial site)
• People with an unexplained elevation in a muscle enzyme called creatine kinase (CK) in blood tests taken before randomisation, where the result is more than 3 times the upper limit of normal and is not explained by recent physical activity or injury
• People who have donated blood, had major blood draws, been in another study, experienced major trauma, had a blood transfusion, or undergone surgery within 30 days before being randomly assigned to a treatment group
• People who have taken any experimental or investigational drug within 30 days before their screening visit
• Employees or contractors of the facility running the study, or immediate family members of the investigators or trial sponsor staff
• People the investigator considers unsuitable for any other reason that could put them at increased risk or affect the reliability of the study results, based on their medical and mental health history, physical examination, or laboratory tests

Important: Always verify eligibility with the trial site directly before applying.