Essential hypertension MedDRA version: 9.1 Level: LLT Classification code 10004254 Term: Benign essential hypertension
Conditions
Interventions
Product Name: Doxazosin
Product Code: Doxazosin
Pharmaceutical Form: Tablet
INN or Proposed INN: Doxazosin
CAS Number: 74191-85-8
Sponsors
Cambridge University Hospitals NHS Foundation Trust jointly with University of Cambridge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Hypertension will be defined as seated pressure >140/90mmHg confirmed on 3 occasions. To be included in the study the patient must have/be: • Male or female • Aged 18-80 years • Able to give informed consent • Newly diagnosed treatment naïve hypertensives or • On at least two antihypertensive agents consisting of and ‘A’ drug (angiotension-2-receptor blocker or ACE-inhibitor) and a diuretic and not reaching target blood pressure and willing to change medication as below. If patients are on more than 2 antihypertensive agents and not at target they will be switched to a combination of ACE-inhibitor, diuretic and calcium channel blocker according to current British Hypertension Society guidelines. If they remain above target they will be enrolled in the study. If switching their medication makes their blood pressure consistently worse by >20/10 mmHg they will not be enrolled in the study. Female patients of child bearing age will have a pregnancy test. 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: Subjects with secondary hypertension, uncontrolled hypertension (>200/110), pregnant or nursing women and women of childbearing age not taking contraceptives or refusing a pregnancy test will be excluded. Patients with contraindications to the study or necessary background medication such as gout, asthma as well as subjects with intolerances to any of the study medication will not be enrolled in the study. Possible interactions of the study medication with the patients’ concomitant medication will be considered and the patient excluded from the study if appropriate. Subjects with heart failure NYHA stage 3 or 4, liver failure (defined as an elevation of ALT four times above upper limit of normal) , renal failure (chronic kidney disease stage 3 or 4) and terminal illnesses (e.g. cancer) as well as very frail patients will be excluded. Patients whose blood pressure consistently rises by more than 20/10mmHg by switching their medication following their screening visit will not be enrolled in the study. Patients unable to give informed consent will not be enrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Primary endpoint is the change in blood pressure according to pre-specified group analysis;Main Objective: The primary objective of the study is to identify whether the effect of different antihypertensive classes depends on the underlying physiological abnormality. ;Secondary Objective: To gain additional data on the physiological effect of the compared antihypertensive drugs. A priori, we will also determine whether haemodynamic profile, age, plasma renin, or starting blood pressure, is the best predictor of blood pressure response between drug classes. | — |
Countries
Estonia, United Kingdom
Outcome results
None listed