Antihypertensive Efficacy and Safety of Candesartan/HCT 32/12.5 and 32/25 mg in Comparison With Candesartan 32 mg
NCT ID: NCT00383929
Last Updated: 2008-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1979 participants
INTERVENTIONAL
2006-09-30
2007-10-31
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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1
Candesartan Cilexetil (CC) /HCT 32/12.5mg
Candesartan cilexetil
32mg oral
Hydrochlorothiazide
12.5 mg oral
2
Candesartan Cilexetil (CC) /HCT 32/25mg
Candesartan cilexetil
32mg oral
Hydrochlorothiazide
25 mg oral
3
Candesartan Cilexetil monotherapy
Candesartan cilexetil
32mg oral
Interventions
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Candesartan cilexetil
32mg oral
Hydrochlorothiazide
12.5 mg oral
Hydrochlorothiazide
25 mg oral
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, which the patient and the physician are willing to withdraw at enrolment and change to candesartan monotherapy
* Mean sitting DBP 90-114 mmHg
* Patients will be eligible for randomisation (Visit 4) if they fulfil the following criterion:
* 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.
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 and verified by a negative pregnancy test at Visit 1
* Secondary or malignant hypertension
* Sitting SBP of 180 mmHg or more
* 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
* 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
* 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
* Chronic liver disease or known liver enzyme values above three times the upper limit of the reference range for S-ASAT or S-ALAT
* Concomitant or previous treatment with other investigational drugs within 20 days of enrolment
* Previous enrolment in the present study
* S-creatinine of 180 μmol/l or above for men and of 140 μmol/l or above for women
* S-sodium or S-potassium outside the reference range
* Less than 85% compliance with study medication during the run-in phase
20 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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Established Brands HTN/CHF Medical Sience Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Gerd Bonner, MD
Role: PRINCIPAL_INVESTIGATOR
MEDIAN Kliniken Bad Krozingen
Locations
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Research Site
Aalborg, , Denmark
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Ballerup Municipality, , Denmark
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Copenhagen, , Denmark
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Frederiksberg, , Denmark
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Herlev, , Denmark
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Vejle, , Denmark
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Pärnu, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Võru, , Estonia
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Albens, , France
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Arras, , France
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Béziers, , France
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Broglie, , France
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Chartres, , France
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Gémenos, , France
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Hinx, , France
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Husseren-Wesserling, , France
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Labarthe-sur-Lèze, , France
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Rosiers-d'Égletons, , France
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Seraincourt, , France
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Strasbourg, , France
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Tours, , France
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Vourey, , France
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Augsburg, , Germany
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Bad Krozingen, , Germany
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Bad Segeberg, , Germany
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Berlin, , Germany
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Bochum, , Germany
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Cloppenburg, , Germany
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Cologne, , Germany
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Dresden, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Goch, , Germany
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Großheirath, , Germany
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Hamburg, , Germany
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Hann, , Germany
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Hermaringen, , Germany
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Herne, , Germany
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Karlsruhe, , Germany
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Kiel, , Germany
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Kippenheim, , Germany
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Künzing, , Germany
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Mannheim, , Germany
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München, , Germany
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Nuremberg, , Germany
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Riesa, , Germany
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Rodgau-dudenhofen, , Germany
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Schwerin, , Germany
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Siegen, , Germany
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Steinfurt, , Germany
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Straßkirchen, , Germany
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Tübingen, , Germany
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Werne, , Germany
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Witten, , Germany
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Kaunas, , Lithuania
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Klaipėda, , Lithuania
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Panevezys, , Lithuania
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Šiauliai, , Lithuania
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Vilnius, , Lithuania
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's-Gravenzande, , Netherlands
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's-Hertogenbosch, , Netherlands
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Bennebroek, , Netherlands
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Deurne, , Netherlands
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Echt, , Netherlands
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Ermelo, , Netherlands
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Hengelo, , Netherlands
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Hoogvliet, , Netherlands
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Lichtenvoorde, , Netherlands
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Losser, , Netherlands
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Musselkanaal, , Netherlands
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Oude Pekela, , Netherlands
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Rijswijk, , Netherlands
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Roelofarendsveen, , Netherlands
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Rotterdam, , Netherlands
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The Hague, , Netherlands
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Volendam, , Netherlands
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Woerden, , Netherlands
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Zaandam, , Netherlands
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Chrzanów, , Poland
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Elblag, , Poland
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Gdansk, , Poland
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Gdynia, , Poland
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Katowice, , Poland
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Lodz, , Poland
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Oława, , Poland
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Poznan, , Poland
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Płock, , Poland
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Skierniewice, , Poland
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Szczecin, , Poland
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Belgrade, , Serbia and Montenegro
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Niska Banja, , Serbia and Montenegro
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Nis, , Serbia and Montenegro
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Sremska Kamenica, , Serbia and Montenegro
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Zemun, , Serbia and Montenegro
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Boden, , Sweden
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Gävle, , Sweden
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Gothenburg, , Sweden
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Linköping, , Sweden
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Malmo, , Sweden
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Motala, , Sweden
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Örebro, , Sweden
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Skellefteå, , Sweden
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Uppsala, , Sweden
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Chenoutsy, , Ukraine
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Dnipro, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Lviv, , Ukraine
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Odesa, , Ukraine
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Addlestone, , United Kingdom
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Ashford, , United Kingdom
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Ayrshire, , United Kingdom
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Burbage, , United Kingdom
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Cheadle, , United Kingdom
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Chesterfield, , United Kingdom
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Coventry, , United Kingdom
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Ely, , United Kingdom
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FIFE, , United Kingdom
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Glasgow, , United Kingdom
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Harrow, , United Kingdom
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Hastings, , United Kingdom
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Helensburgh, , United Kingdom
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Morriston, , United Kingdom
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Motherwell, , United Kingdom
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Newton Mearns, , United Kingdom
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Northwood Middlesex, , United Kingdom
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Paignton, , United Kingdom
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Royal Leamington Spa, , United Kingdom
Research Site
Wokingham, , United Kingdom
Countries
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Other Identifiers
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Eudract No. 2005-005718-19
Identifier Type: -
Identifier Source: secondary_id
D2456C00001
Identifier Type: -
Identifier Source: org_study_id