Resistant hypertension. MedDRA version: 8.1 Level: LLT Classification code 10020772 Term: Hypertension
Conditions
Interventions
Trade Name: Spironolactone Tablets BP 25 mg
Pharmaceutical Form: Coated tablet
INN or Proposed INN: SPIRONOLACTONE
CAS Number: 52-01-7
Current Sponsor code: STH 14399
Concentration unit: mg milligram(
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Aged>18 years. Hypertension (essential or secondary) managed in Sheffield Hypertension Clinic or General Practice or both. Blood pressures not adequately controlled (SBP >140 mmHg and/or DBP >85 mmHg in clinic and on daytime mean ambulatory blood pressure monitoring) despite treatment with the maximum tolerated dose of 3 antihypertensive agents. Additional antihypertensive treatment deemed appropriate by the patients' doctor. Patients' current antihypertensive treatment includes a thiazide diuretic and a least one of: a beta blocker, angiotensin converting enzyme inhibitor or angiotensin II receptor antagonist (i.e. modern antihypertensive regime where spironolactone is least likely to be effective). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Definite indication or contraindication for spironolactone. Known Conn's syndrome. Heart failure NYHA class III or IV. Known hepatic failure or significant cirrhosis. Known pregnancy or women planning pregnancy. Women of child-bearing potential not using adequate contraception methods. Serum creatinine >221 µmol/l. Serum potassium >5 mmol/l. Clinic blood pressure or daytime ambulatory blood pressure >240/120 mmHg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the antihypertensive efficacy of adding spironolactone to the antihypertensive treatment of patients with resistant hypertension. ;Secondary Objective: To assess the safety of adding spironolactone to the antihypertensive treatment of patients with resistant hypertension. ;Primary end point(s): The primary end point will be the difference between the spironolctone and placebo groups in change in daytime average systolic blood pressure on ABPM from day 0 to day 42. | — |
Countries
United Kingdom
Outcome results
None listed