Clinical trial NCT00383929: Antihypertensive Efficacy and Safety of Candesartan/HCT 32/12.5 and 32/25 mg in Comparison With Candesartan 32 mg
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Blood pressure reduction
combination therapy
candesartan cilexetil
hydrochlorothiazide
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-10-04
Enrollment: 1979
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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, 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:

* 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
* 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

Primary outcomes:
measure: Change (reduction) in sitting BP (24 hours after dose)
timeFrame: Assessed from baseline (randomisation) to the end of the study.
Secondary outcomes:
measure: Proportion of patients with controlled sitting BP in each treatment group
timeFrame: Assessed at the end of the study
measure: Occurrence of Adverse Events and discontinuation of study medication due to AEs from baseline (randomisation) to the end of the study
timeFrame: Assessed from baseline (randomisation) to the end of the study.
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Research Site
city: Ballerup
country: Denmark
facility: Research Site
city: Frederiksberg
country: Denmark
facility: Research Site
city: Herlev
country: Denmark
facility: Research Site
city: Kobenhavn
country: Denmark
facility: Research Site
city: Vejle
country: Denmark
facility: Research Site
city: Parnu
country: Estonia
facility: Research Site
city: Tallinn
country: Estonia
facility: Research Site
city: Tartu
country: Estonia
facility: Research Site
city: Voru
country: Estonia
facility: Research Site
city: Belgrade
country: Former Serbia and Montenegro
facility: Research Site
city: Niska Banja
country: Former Serbia and Montenegro
facility: Research Site
city: Nis
country: Former Serbia and Montenegro
facility: Research Site
city: Sremska Kamenica
country: Former Serbia and Montenegro
facility: Research Site
city: Zemun
country: Former Serbia and Montenegro
facility: Research Site
city: Albens
country: France
facility: Research Site
city: Arras
country: France
facility: Research Site
city: Beziers
country: France
facility: Research Site
city: Broglie
country: France
facility: Research Site
city: Chartres
country: France
facility: Research Site
city: Gemenos
country: France
facility: Research Site
city: Hinx
country: France
facility: Research Site
city: Husseren-wesserling
country: France
facility: Research Site
city: Labarthe-sur-Leze
country: France
facility: Research Site
city: Rosiers d'Egletons
country: France
facility: Research Site
city: Seraincourt
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Tours
country: France
facility: Research Site
city: Vourey
country: France
facility: Research Site
city: Augsburg
country: Germany
facility: Research Site
city: Bad Krozingen
country: Germany
facility: Research Site
city: Bad Segeberg
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bochum
country: Germany
facility: Research Site
city: Cloppenburg
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Erlangen
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Goch
country: Germany
facility: Research Site
city: Grossheirath
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hann
country: Germany
facility: Research SIte
city: Hermaringen
country: Germany
facility: Research Site
city: Herne
country: Germany
facility: Research Site
city: Karlsruhe
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Kippenheim
country: Germany
facility: Research Site
city: Koeln
country: Germany
facility: Research Site
city: Kunzing
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Nürnberg
country: Germany
facility: Research Site
city: Riesa
country: Germany
facility: Research Site
city: Rodgau-dudenhofen
country: Germany
facility: Research Site
city: Schwerin
country: Germany
facility: Research Site
city: Siegen
country: Germany
facility: Research Site
city: Steinfurt
country: Germany
facility: Research Site
city: Strasskirchen
country: Germany
facility: Research Site
city: Tübingen
country: Germany
facility: Research Site
city: Werne
country: Germany
facility: Research Site
city: Witten
country: Germany
facility: Research Site
city: Kaunas
country: Lithuania
facility: Research Site
city: Klaipeda
country: Lithuania
facility: Research Site
city: Panevezys
country: Lithuania
facility: Research Site
city: Siauliai
country: Lithuania
facility: Research Site
city: Vilnius
country: Lithuania
facility: Research Site
city: Bennebroek
country: Netherlands
facility: Research Site
city: Den Haag
country: Netherlands
facility: Research Site
city: Deurne
country: Netherlands
facility: Research Site
city: Echt
country: Netherlands
facility: Research Site
city: Ermelo
country: Netherlands
facility: Research Site
city: Hengelo
country: Netherlands
facility: Research Site
city: Hoogvliet
country: Netherlands
facility: Research Site
city: Lichtenvoorde
country: Netherlands
facility: Research Site
city: Losser
country: Netherlands
facility: Research Site
city: Musselkanaal
country: Netherlands
facility: Research Site
city: Oude Pekela
country: Netherlands
facility: Research Site
city: Rijswijk
country: Netherlands
facility: Research Site
city: Roelofarendsveen
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: s Hertogenbosch
country: Netherlands
facility: Research Site
city: s-Gravenzande
country: Netherlands
facility: Research Site
city: Volendam
country: Netherlands
facility: Research Site
city: Woerden
country: Netherlands
facility: Research Site
city: Zaandam
country: Netherlands
facility: Research Site
city: Chrzanow
country: Poland
facility: Research Site
city: Elblag
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Gdynia
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Olawa
country: Poland
facility: Research Site
city: Plock
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Skierniewice
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Boden
country: Sweden
facility: Research Site
city: Gävle
country: Sweden
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Linköping
country: Sweden
facility: Research Site
city: Malmö
country: Sweden
facility: Research Site
city: Motala
country: Sweden
facility: Research Site
city: Skellefteå
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Örebro
country: Sweden
facility: Research Site
city: Chenoutsy
country: Ukraine
facility: Research Site
city: Dnepropetrovsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kharkov
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Lviv
country: Ukraine
facility: Research Site
city: Odessa
country: Ukraine
facility: Research Site
city: Addlestone
country: United Kingdom
facility: Research Site
city: Ashford
country: United Kingdom
facility: Research Site
city: Ayrshire
country: United Kingdom
facility: Research Site
city: Burbage
country: United Kingdom
facility: Research Site
city: Cheadle
country: United Kingdom
facility: Research Site
city: Chesterfield
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: ELY
country: United Kingdom
facility: Research Site
city: Fife
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Harrow
country: United Kingdom
facility: Research Site
city: Hastings
country: United Kingdom
facility: Research Site
city: Helensburgh
country: United Kingdom
facility: Research Site
city: Leamington Spa
country: United Kingdom
facility: Research Site
city: Morriston
country: United Kingdom
facility: Research Site
city: Motherwell
country: United Kingdom
facility: Research Site
city: Newton Mearns
country: United Kingdom
facility: Research Site
city: Northwood Middlesex
country: United Kingdom
facility: Research Site
city: Paignton
country: United Kingdom
facility: Research Site
city: Wokingham
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Established Brands HTN/CHF Medical Sience Director, MD
role: STUDY_DIRECTOR
affiliation: MEDIAN Kliniken Bad Krozingen
name: Gerd Bonner, MD
role: PRINCIPAL_INVESTIGATOR
References: