Hypertension MedDRA version: 9.1 Level: LLT Classification code 10020772 Term: Hypertension
Conditions
Interventions
Product Name: candesartan cilexetil/HCT 32/12.5 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: candesartan cilexetil
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration nu
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 12. Gout 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Change (reduction) in sitting DBP (24 hours after dose) from baseline (randomisation) to the end of the study (8 weeks);Main Objective: 1. To compare sitting Diastolic Blood Pressure (DBP) lowering effect of candesartan/HCT 32/25 mg with that of candesartan 32 mg. 2. To compare sitting Systolic Blood Pressure (SBP) lowering effect of candesartan/HCT 32/25 mg with that of candesartan 32 mg. 3. To compare sitting DBP lowering effect of candesartan/HCT 32/12.5 mg with that of candesartan 32 mg. 4. To compare sitting SBP lowering effect of candesartan/HCT 32/12.5 mg with that of candesartan 32 mg. ;Secondary Objective: 1. Compare sitting DBP lowering effect of candesartan/HCT 32/25 mg with that of candesartan/HCT 32/12.5 mg. 2. Compare sitting Systolic Blood Pressure (SBP) lowering effect of candesartan/HCT 32/25 mg with that of candesartan/HCT 32/12.5 mg. 3. Compare the proportion of patients with controlled sitting SBP and sitting DBP on - candesartan/HCT 32/25 mg and on candesartan 32 mg respectively, at the end of the study. - candesartan/HCT 32/12.5 mg and on candesartan 32 mg respectively, at the end of the study. - candesartan/HCT 32/25 mg and on candesartan/HCT 32/12.5 mg respectively, at the end of the study. 4. Assess safety and tolerability of - candesartan/HCT 32/25 mg in comparison to candesartan 32 mg. - candesartan/HCT 32/12.5 mg in comparison to candesartan 32 mg. - candesartan/HCT 32/25 mg in comparison to candesartan/HCT 32/12.5 mg. | — |
Countries
Estonia, Germany, Lithuania, Netherlands, Sweden, United Kingdom
Outcome results
None listed