Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT00430794
Eligibility Criteria:
Inclusion Criteria:
* Aged over 18 years
* Hypertension (essential or secondary) managed in Sheffield Hypertension Clinic or general practice or both.
* Blood pressures not adequately controlled (systolic blood pressure (SBP) \>140 mmHg and/or diastolic blood pressure (DBP) \>85 mmHg in clinic and on ambulatory blood pressure monitoring) despite treatment with the maximum tolerated dose of three antihypertensive agents.
* Additional antihypertensive treatment deemed appropriate by the patients' doctor.
* Patients' current antihypertensive treatment includes a thiazide diuretic and at least one of a beta-blocker, angiotensin converting enzyme inhibitor or angiotensin II receptor antagonist.
Exclusion Criteria:
* Definite indication or contraindication for spironolactone
* Known Conn's syndrome (definite indication for spironolactone)
* Heart failure NYHA class III or IV (definite indication for spironolactone)
* Known hepatic failure or significant cirrhosis
* Known pregnancy or women planning pregnancy
* Women of child bearing potential not using adequate contraceptive methods
* Serum creatinine \> 221µmol/l
* Serum Potassium \> 5.0mmol/l
* Clinic blood pressure or daytime ambulatory blood pressure \>240/120
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00430794
Study Brief:
Protocol Section:
NCT00430794