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

Phase 1

• Conditions: Hypertension; MedDRA version: 9.0Level: LLTClassification code 10020772

• Registration Number: EUCTR2005-005718-19-NL
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-28
• Study Completion: 2007-08-17
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2000

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified