Antihypertensive Efficacy and Safety of Candesartan/HCT 32/12.5 and 32/25 mg in Comparison With Candesartan 32 mg

Launched by ASTRAZENECA · Oct 3, 2006

Keywords

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Gender

ALL

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