Clinical trial NCT00383929 (phase 3, status: completed)
Conditions: hypertension
ICD codes: I15.0, I97.3, K76.6, P29.2, G93.2, H40.053, I10
Drugs: candesartan cilexetil, hydrochlorothiazide, hydrochlorothiazide
SMILES: CCOC1=NC2=C(N1CC1=CC=C(C=C1)C1=CC=CC=C1C1=NN=NN1)C(=CC=C2)C(=O)OC(C)OC(=O)OC1CCCCC1, COCCC1=CC=C(OCC(O)CNC(C)C)C=C1, COCCC1=CC=C(OCC(O)CNC(C)C)C=C1
Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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