Antihypertensive Efficacy and Safety of Candesartan/HCT 32/12.5 and 32/25 mg in Comparison With Candesartan 32 mg
A Double Blind, Randomised, 3-Arm Parallel Group, Multicentre, 8-Week, Phase III Study to Assess Antihypertensive Efficacy and Safety of the Combination of Candesartan Cilexetil (CC) /HCT 32/12.5mg and 32/25mg vs. CC 32mg Alone in Patients With Inadequate BP Control on Monotherapy With CC 32mg
2 other identifiers
interventional
1,979
10 countries
123
Brief Summary
In this study it is intended to compare the blood pressure lowering effect of the combination of candesartan cilexetil (candesartan) 32 mg and hydrochlorothiazide (HCT) 25 mg and the combination of candesartan 32 mg and HCT 12.5 mg to that of candesartan 32 mg alone in patients whose blood pressure is not well controlled on candesartan 32 mg monotherapy. The Primary Objectives are to compare sitting BP lowering effect of candesartan/HCT 32/25 mg and candesartan/HCT 32/12.5 mg with that of candesartan 32 mg, respectively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hypertension
Started Sep 2006
123 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 3, 2006
CompletedFirst Posted
Study publicly available on registry
October 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedMarch 20, 2008
March 1, 2008
11 months
October 3, 2006
March 19, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change (reduction) in sitting BP (24 hours after dose)
Assessed from baseline (randomisation) to the end of the study.
Secondary Outcomes (2)
Proportion of patients with controlled sitting BP in each treatment group
Assessed at the end of the study
Occurrence of Adverse Events and discontinuation of study medication due to AEs from baseline (randomisation) to the end of the study
Assessed from baseline (randomisation) to the end of the study.
Study Arms (3)
1
EXPERIMENTALCandesartan Cilexetil (CC) /HCT 32/12.5mg
2
EXPERIMENTALCandesartan Cilexetil (CC) /HCT 32/25mg
3
EXPERIMENTALCandesartan Cilexetil monotherapy
Interventions
Eligibility Criteria
You may qualify if:
- 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, 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.
You may not qualify if:
- Involvement in the planning and conduct of the study (applies to both AstraZeneca staff, CRO staff or staff at the investigational centre)
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (132)
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
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Wokingham, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Established Brands HTN/CHF Medical Sience Director, MD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Gerd Bonner, MD
MEDIAN Kliniken Bad Krozingen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 3, 2006
First Posted
October 4, 2006
Study Start
September 1, 2006
Primary Completion
August 1, 2007
Study Completion
October 1, 2007
Last Updated
March 20, 2008
Record last verified: 2008-03