Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
Age
20–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients will be eligible for enrolment into the study (Visit 1) if they fulfil all of the following criteria:
Provision of signed Informed Consent
Primary hypertension, untreated or treated with a maximum of 2 antihypertensive drugs, which the patient and the physician are willing to withdraw at enrolment and change to candesartan monotherapy
Mean sitting DBP 90-114 mmHg
Patients will be eligible for randomisation (Visit 4) if they fulfil the following criterion:
Mean sitting DBP 90-114 mmHg on treatment with candesartan 32 mg monotherapy (after 2 weeks with candesartan 16 mg and 6 weeks with candesartan 32 mg monotherapy). The run-in period should not be shorter than 8 weeks.
You may not be if
Involvement in the planning and conduct of the study (applies to both AstraZeneca staff, CRO staff or staff at the investigational centre)
Pregnant or lactating women, or women of childbearing potential not practising an adequate method of contraception eg, intrauterine device, oral contraception or progesterone implant and verified by a negative pregnancy test at Visit 1
Secondary or malignant hypertension
Sitting SBP of 180 mmHg or more
Patients who are treated with candesartan 16 mg in combination with a diuretic or with candesartan 32 mg with or without any additional antihypertensive treatment
Myocardial infarction, stroke, coronary bypass surgery or transient ischaemic attack within 6 months before enrolment
Angina pectoris requiring more treatment than short-acting nitrates
Chronic use of NSAIDs
Aortic or mitral valve stenosis
Cardiac failure requiring treatment
Cardiac arrhythmia requiring treatment
Gout
Renal artery stenosis or kidney transplantation
Intravascular volume depletion
Hypersensitivity to any component of the investigational products
Concomitant disease which may interfere with the assessment of the patient
Past or present alcohol or drug abuse, or any condition associated with poor compliance
Chronic liver disease or known liver enzyme values above three times the upper limit of the reference range for S-ASAT or S-ALAT
Concomitant or previous treatment with other investigational drugs within 20 days of enrolment
Previous enrolment in the present study
S-creatinine of 180 μmol/l or above for men and of 140 μmol/l or above for women
S-sodium or S-potassium outside the reference range
Less than 85% compliance with study medication during the run-in phase
Clareo Health | Antihypertensive Efficacy and Safety of Candesartan/HCT 32/12.5 and 32/25 mg in Comparison With Candesartan 32 mg
