EUCTR2005-005718-19-SE进行中（未招募）不适用
A Double Blind, Randomised, 3-arm Parallel Group, Multicentre, 8-week, Phase III Study to Assess the Antihypertensive Efficacy and Safety of the Combination of Candesartan Cilexetil/Hydrochlorothiazide 32/12.5 mg and 32/25 mg in Comparison with Candesartan Cilexetil 32 mg Alone in Patients with Inadequate Blood Pressure Control on Monotherapy with Candesartan Cilexetil 32 mg
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 4,391
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients will be eligible for enrolment into the study (Visit 1) if they fulfil all of the following criteria:
- •1. Provision of signed Informed Consent
- •2. Male or female aged 20-80 years
- •3. 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 (please see also exclusion criterion 5)
- •4. Mean sitting DBP 90-114 mmHg*
- •Patients will be eligible for randomisation (Visit 4) if they fulfil the following criterion:
- •5. 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.
- •*Value calculated in the eCRF.
- •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
排除标准
- •Patients will be excluded from enrolment into the study if they fulfil any of the following criteria:
- •1. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff, CRO staff or staff at the investigational centre)
- •2. 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
- •3. Secondary or malignant hypertension
- •4. Sitting SBP of 180 mmHg or more
- •5. 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
- •6. Myocardial infarction, stroke, coronary bypass surgery or transient ischaemic attack within 6 months before enrolment
- •7. Angina pectoris requiring more treatment than short-acting nitrates
- •8. Chronic use of NSAIDs
- •9. Aortic or mitral valve stenosis
- •10. Cardiac failure requiring treatment
- •11. Cardiac arrhythmia requiring treatment
- •13. Renal artery stenosis or kidney transplantation
- •14. Intravascular volume depletion
- •15. Hypersensitivity to any component of the investigational products or to any sulphonamide derived drugs
- •16. Concomitant disease which may interfere with the assessment of the patient
- •17. Past or present alcohol or drug abuse, or any condition associated with poor compliance
- •18. Chronic liver disease or known liver enzyme values above three times the upper limit of the reference range for S-ASAT or S-ALAT
- •19. Concomitant or previous treatment with other investigational drugs within 20 days of enrolment
- •20. Previous enrolment in the present study
- •Patients will be excluded at Visit 2 if they fulfil the following criteria:
- •21. Liver enzyme values above three times the upper limit of the central laboratory's reference range for S-ASAT or S-ALAT
- •22. S-creatinine of 180 µmol/l or above for men and of 140 µmol/l or above for women
- •23. S-sodium or S-potassium outside the reference range of the central laboratory
- •Patients will be excluded from randomisation if they fulfil the following criterion:
- •24. Less than 85% compliance with study medication during the run-in phase between Visit 2 and Visit 4
- •25. S-calcium above the reference range of the central laboratory
研究者
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