Title
Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and Placebo
A Double-blind, Randomised, 4-arm Parallel Group, Multicentre, 8-week, Phase III Study to Assess the Antihypertensive Efficacy and Safety of the Combination of Candesartan Cilexetil (CC) 32 mg and Hydrochlorothiazide (HCT) 25 mg Compared With CC 32 mg, HCT 25 mg and Placebo in Hypertensive Adults
Phase
Phase 3Lead Sponsor
AstraZenecaStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
HypertensionIntervention/Treatment
candesartan hydrochlorothiazide ...Study Participants
2207The 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.
32 mg oral tablet
25 mg oral tablet
Placebo
Candesartan cilexetil + Hydrochlorothiazide Combination
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
| Event Type | Organ System | Event Term | Placebo | Candesartan 32 mg | HCT 25 mg | Candesartan/HCT 32/25 mg |
|---|
Change (reduction) in sitting DBP at the end of the study, when compared to sitting DBP at baseline.
Change (reduction) in sitting SBP at the end of the study, when compared to sitting SBP at baseline.
Controlled sitting SBP and sitting DBP are defined as having sitting SBP < 140 mmHg and sitting DBP < 90 mmHg at the end of the study
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
