Hypertension MedDRA version: 9 Level: LLT Classification code 10020772
Conditions
Interventions
Trade Name: Atacand Plus
Product Name: Candesartan cilexetil/hydrochlorothiazide 16/12.5 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Candesartan cilexetil
Concentration unit: mg milligram(s)
C
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be eligible for the study 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 (substances), which the patient and the physician are willing to withdraw at enrolment and replace with placebo. 4. Mean sitting DBP 90-114 mmHg (value calculated in the eCRF) at Visits 1 and 2. Patients will be eligible for randomisation (Visit 4) if they fulfil the following criterion: 5. Mean sitting DBP of 90-114 mmHg (value calculated in the eCRF) at the end of the 4-week single-blind placebo run-in period. The run-in period should not be shorter than 4 weeks. 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 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, Contract Research Organisation 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. Pregnancy must be excluded by a negative pregnancy test at Visit 1. 3. Secondary or malignant hypertension. 4. Sitting SBP of 180 mmHg or more. 5. Myocardial infarction, stroke, coronary bypass surgery or transient ischaemic attack within 6 months before enrolment. 6. Angina pectoris requiring more treatment than short-acting nitrates. 7. Chronic use of NSAIDs. 8. Aortic or mitral valve stenosis. 9. Cardiac failure requiring treatment. 10. Cardiac arrhythmia requiring treatment. 11. Gout. 12. Renal artery stenosis or kidney transplantation. 13. Intravascular volume depletion. 14. Hypersensitivity to any component of the investigational products or to any sulphonamide derived drugs. 15. Concomitant disease which may interfere with the assessment of the patient. 16. Past or present alcohol or drug abuse, or any condition associated with poor compliance that in the opinion of the investigator might affect the patient’s participation in the study. 17. Chronic liver disease. 18. Concomitant or previous treatment with any other investigational drug within 20 days of enrolment. 19. Previous enrolment in the present study. Patients will be excluded at Visit 2 if they fulfil any of the following criteria: 20. Liver enzyme values above three times the upper limit of the central laboratory’s reference range for S-ASAT or S-ALAT (based on sample taken at Visit 1). 21. S-creatinine of 180 µmol/l or above for men and of 140 µmol/l or above for women (based on sample taken at Visit 1). 22. S-sodium, S-potassium or S-calcium outside the reference range of the central laboratory (based on sample taken at Visit 1). Patients will be excluded from randomisation (Visit 4) if they fulfil the following criteria: 23. Positive pregnancy test 24. Less than 85% compliance with study medication during the run-in phase between Visit 2 and Visit 4. (Sitting DBP 90 – 114 mmHg criterion should also be fulfilled, see Section 3.3.2, Inclusion criteria, No. 5)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1.To compare sitting DBP lowering effect of candesartan cilexetil (candesartan)/hydrochlorothiazide (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 32/25 mg with that of HCT 25 mg. 4. To compare sitting SBP lowering effect of candesartan/HCT 32/25 mg with that of HCT 25 mg. ;Secondary Objective: ··To compare candesartan/HCT 32/25 mg and each of its components to placebo with regard to change in sitting blood pressures. ·To compare candesartan/HCT 32/25 mg to its components and to placebo with regard to hypertension control rate at the end of the study (patients with controlled sitting SBP and DBP are defined as having SBP <140 mmHg and DBP <90 mmHg at the end of the study). ·To describe safety of the study treatments with regard to adverse events including those that lead to treatment discontinuation as well as with regard to pulse rate, laboratory, electrocardiographic and physical examination findings.;Primary end point(s): Change in sitting DBP (24 hours after dose) from baseline (randomisation) to the end of the study (8 weeks). Change in sitting SBP (24 hours after dose) from baseline (randomisation) to the end of the study (8 weeks) | — |
Countries
Estonia, Hungary, Latvia, Lithuania, Malta
Outcome results
None listed