HypertensionPhase 3NCT00383929
Antihypertensive Efficacy and Safety of Candesartan/HCT 32/12.5 and 32/25 mg in Comparison With Candesartan 32 mg
A Phase 3 study testing Candesartan cilexetil and Hydrochlorothiazide in people with Hypertension, run by AstraZeneca at 132 sites in 11 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Candesartan cilexetil and Hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,979 participants
- Where
- 132 sitesin 11 countries
- Study dates
- Sep 2006to Oct 2007
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
132 sites in 11 countries.
132 sites in 11 countries
Germany33 sites
Research Site
Augsburg
Research Site
Bad Krozingen
Research Site
Bad Segeberg
Research Site
Berlin
Research Site
Bochum
Research Site
Cloppenburg
Research Site
Cologne
Research Site
Dresden
Research Site
Erlangen
Research Site
Essen
Research Site
Frankfurt
Research Site
Goch
Research Site
Großheirath
Research Site
Hamburg
Research SIte
Hann
Research Site
Hermaringen
Research Site
Herne
Research Site
Karlsruhe
Research Site
Kiel
Research Site
Kippenheim
Research Site
Künzing
Research Site
Mannheim
Research Site
München
Research Site
Nuremberg
Research Site
Riesa
Research Site
Rodgau-dudenhofen
Research Site
Schwerin
Research Site
Siegen
Research Site
Steinfurt
Research Site
Straßkirchen
Research Site
Tübingen
Research Site
Werne
Research Site
Witten
United Kingdom20 sites
Research Site
Addlestone
Research Site
Ashford
Research Site
Ayrshire
Research Site
Burbage
Research Site
Cheadle
Research Site
Chesterfield
Research Site
Coventry
Research Site
Ely
Research Site
FIFE
Research Site
Glasgow
Research Site
Harrow
Research Site
Hastings
Research Site
Helensburgh
Research Site
Morriston
Research Site
Motherwell
Research Site
Newton Mearns
Research Site
Northwood Middlesex
Research Site
Paignton
Research Site
Royal Leamington Spa
Research Site
Wokingham
Netherlands19 sites
Research Site
's-Gravenzande
Research Site
's-Hertogenbosch
Research Site
Bennebroek
Research Site
Deurne
Research Site
Echt
Research Site
Ermelo
Research Site
Hengelo
Research Site
Hoogvliet
Research Site
Lichtenvoorde
Research Site
Losser
Research Site
Musselkanaal
Research Site
Oude Pekela
Research Site
Rijswijk
Research Site
Roelofarendsveen
Research Site
Rotterdam
Research Site
The Hague
Research Site
Volendam
Research Site
Woerden
Research Site
Zaandam
France14 sites
Research Site
Albens
Research Site
Arras
Research Site
Béziers
Research Site
Broglie
Research Site
Chartres
Research Site
Gémenos
Research Site
Hinx
Research Site
Husseren-Wesserling
Research Site
Labarthe-sur-Lèze
Research Site
Rosiers-d'Égletons
Research Site
Seraincourt
Research Site
Strasbourg
Research Site
Tours
Research Site
Vourey
Poland11 sites
Research Site
Chrzanów
Research Site
Elblag
Research Site
Gdansk
Research Site
Gdynia
Research Site
Katowice
Research Site
Lodz
Research Site
Oława
Research Site
Płock
Research Site
Poznan
Research Site
Skierniewice
Research Site
Szczecin
Sweden9 sites
Research Site
Boden
Research Site
Gävle
Research Site
Gothenburg
Research Site
Linköping
Research Site
Malmö
Research Site
Motala
Research Site
Örebro
Research Site
Skellefteå
Research Site
Uppsala
Denmark6 sites
Research Site
Aalborg
Research Site
Ballerup Municipality
Research Site
Copenhagen
Research Site
Frederiksberg
Research Site
Herlev
Research Site
Vejle
Ukraine6 sites
Research Site
Chenoutsy
Research Site
Dnipro
Research Site
Kharkiv
Research Site
Kyiv
Research Site
Lviv
Research Site
Odesa
Lithuania5 sites
Research Site
Kaunas
Research Site
Klaipėda
Research Site
Panevezys
Research Site
Šiauliai
Research Site
Vilnius
Serbia and Montenegro5 sites
Research Site
Belgrade
Research Site
Nis
Research Site
Niska Banja
Research Site
Sremska Kamenica
Research Site
Zemun
Estonia4 sites
Research Site
Pärnu
Research Site
Tallinn
Research Site
Tartu
Research Site
Võru
About this study
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
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.
- Conditions
- Hypertension
- Being tested
- Candesartan cilexetil, Hydrochlorothiazide
- Keywords
- Blood pressure reduction, combination therapy, candesartan cilexetil, hydrochlorothiazide
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candesartan cilexetilDrug
Also called ATACAND
32mg oral
HydrochlorothiazideDrug
Also called HCTZ
12.5 mg oral
HydrochlorothiazideDrug
Also called HCTZ
25 mg oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Candesartan Cilexetil (CC) /HCT 32/12.5mg Receives: Drug: Candesartan cilexetil; Drug: Hydrochlorothiazide |
| 2 | Experimental | Candesartan Cilexetil (CC) /HCT 32/25mg Receives: Drug: Candesartan cilexetil; Drug: Hydrochlorothiazide |
| 3 | Experimental | Candesartan Cilexetil monotherapy Receives: Drug: Candesartan cilexetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change (reduction) in sitting BP (24 hours after dose)
Measured: Assessed from baseline (randomisation) to the end of the study.
Secondary outcomes (2)
Proportion of patients with controlled sitting BP in each treatment group
Measured: 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
Measured: Assessed from baseline (randomisation) to the end of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionAug 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,979 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Established Brands HTN/CHF Medical Sience Director, MD, Study director, AstraZenecaGerd Bonner, MD, Principal investigator, MEDIAN Kliniken Bad Krozingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383929
- Sponsor's protocol ID
- D2456C00001
- Other IDs
- Eudract No. 2005-005718-19
- Status last verified
- Mar 2008
- First submitted
- 3 Oct 2006
- Last updated
- 20 Mar 2008
- Results posted
- No