Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and Placebo
NCT ID: NCT00434967
Last Updated: 2010-12-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2207 participants
INTERVENTIONAL
2007-01-31
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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4
Placebo
No interventions assigned to this group
2
Candesartan cilexetil
Candesartan cilexetil
32 mg oral tablet
3
Hydrochlorothiazide (HCT)
Hydrochlorothiazide
25 mg oral tablet
1
Candesartan cilexetil + Hydrochlorothiazide Combination
Candesartan cilexetil
32 mg oral tablet
Hydrochlorothiazide
25 mg oral tablet
Candesartan/HCT 32/25 mg
Interventions
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Candesartan cilexetil
32 mg oral tablet
Hydrochlorothiazide
25 mg oral tablet
Candesartan/HCT 32/25 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
20 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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Michael Klibaner, MD
Role: STUDY_DIRECTOR
AstraZeneca
Istvan Edes, MD
Role: PRINCIPAL_INVESTIGATOR
DEOEC Institute of Cardiology
Locations
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Research Site
Dour, , Belgium
Research Site
Gozée, , Belgium
Research Site
Hasselt, , Belgium
Research Site
Linkebeek, , Belgium
Research Site
Marchovelette, , Belgium
Research Site
Ronquières, , Belgium
Research Site
Saint-Médard, , Belgium
Research Site
Steenokkerzel, , Belgium
Research Site
Daugavpils, , Latvia
Research Site
Ogre, , Latvia
Research Site
Riga, , Latvia
Research Site
Gozo, , Malta
Research Site
Gwardiamangia, , Malta
Research Site
Arad, , Romania
Research Site
Bucharest, , Romania
Research Site
Iași, , Romania
Research Site
Piteşti, , Romania
Research Site
Ploieşti, , Romania
Research Site
Târgovişte, , Romania
Research Site
Timișoara, , Romania
Research Site
Moscow, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Bratislava, , Slovakia
Research Site
Levice, , Slovakia
Research Site
Lučenec, , Slovakia
Research Site
Prešov, , Slovakia
Research Site
Šahy, , Slovakia
Countries
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Other Identifiers
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EudraCT No. 2006-003963-30
Identifier Type: -
Identifier Source: secondary_id
D2456C00002
Identifier Type: -
Identifier Source: org_study_id