Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and Placebo

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Candesartan/HCT 32/25 mg; Drug: Hydrochlorothiazide; Drug: Candesartan cilexetil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00434967

D2456C00002

EudraCT No. 2006-003963-30

Details and patient eligibility

About

The aim is to compare the blood pressure lowering effect of the combination of candesartan cilexetil (candesartan) 32 mg and hydrochlorothiazide (HCT) 25 mg to that of candesartan 32 mg alone, HCT 25 mg alone and placebo in hypertensive adults.

Enrollment: 2,207 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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 (substances), which the patient and the physician are willing to withdraw at enrolment and replace with placebo.
• 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:
• 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.

Exclusion criteria

• 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.
• Secondary or malignant hypertension
• Sitting SBP of 180 mmHg or more
• 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 or to any sulphonamide derived drugs
• 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 that in the opinion of the investigator might affect the patient's participation in the study
• Chronic liver disease
• Concomitant or previous treatment with any other investigational drug within 20 days of enrolment
• Previous enrolment in the present study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,207 participants in 4 patient groups

4

No Intervention group

Description:

Placebo

2

Active Comparator group

Description:

Candesartan cilexetil

Treatment:

Drug: Candesartan cilexetil

3

Active Comparator group

Description:

Hydrochlorothiazide (HCT)

Treatment:

Drug: Hydrochlorothiazide

1

Experimental group

Description:

Candesartan cilexetil + Hydrochlorothiazide Combination

Treatment:

Drug: Candesartan cilexetil

Drug: Candesartan/HCT 32/25 mg

Drug: Hydrochlorothiazide