Antihypertensive Efficacy and Safety of Candesartan/HCT 32/12.5 and 32/25 mg in Comparison With Candesartan 32 mg

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00383929
• Other study ID #: D2456C00001
• Secondary ID: Eudract No. 2005
• Status: Completed
• Phase: Phase 3
• First received: October 3, 2006
• Last updated: March 19, 2008
• Start date: September 2006
• Est. completion date: October 2007

Study information

• Verified date: March 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1979
• Est. completion date: October 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Candesartan cilexetil
32mg oral
• Hydrochlorothiazide
12.5 mg oral
• Hydrochlorothiazide
25 mg oral

Locations

Country	Name	City	State
Denmark	Research Site	Aalborg
Denmark	Research Site	Ballerup
Denmark	Research Site	Frederiksberg
Denmark	Research Site	Herlev
Denmark	Research Site	Kobenhavn
Denmark	Research Site	Vejle
Estonia	Research Site	Parnu
Estonia	Research Site	Tallinn
Estonia	Research Site	Tartu
Estonia	Research Site	Voru
Former Serbia and Montenegro	Research Site	Belgrade
Former Serbia and Montenegro	Research Site	Nis
Former Serbia and Montenegro	Research Site	Niska Banja
Former Serbia and Montenegro	Research Site	Sremska Kamenica
Former Serbia and Montenegro	Research Site	Zemun
France	Research Site	Albens
France	Research Site	Arras
France	Research Site	Beziers
France	Research Site	Broglie
France	Research Site	Chartres
France	Research Site	Gemenos
France	Research Site	Hinx
France	Research Site	Husseren-wesserling
France	Research Site	Labarthe-sur-Leze
France	Research Site	Rosiers d'Egletons
France	Research Site	Seraincourt
France	Research Site	Strasbourg
France	Research Site	Tours
France	Research Site	Vourey
Germany	Research Site	Augsburg
Germany	Research Site	Bad Krozingen
Germany	Research Site	Bad Segeberg
Germany	Research Site	Berlin
Germany	Research Site	Bochum
Germany	Research Site	Cloppenburg
Germany	Research Site	Dresden
Germany	Research Site	Erlangen
Germany	Research Site	Essen
Germany	Research Site	Frankfurt
Germany	Research Site	Goch
Germany	Research Site	Grossheirath
Germany	Research Site	Hamburg
Germany	Research SIte	Hann
Germany	Research Site	Hermaringen
Germany	Research Site	Herne
Germany	Research Site	Karlsruhe
Germany	Research Site	Kiel
Germany	Research Site	Kippenheim
Germany	Research Site	Koeln
Germany	Research Site	Köln
Germany	Research Site	Kunzing
Germany	Research Site	Mannheim
Germany	Research Site	München
Germany	Research Site	Nürnberg
Germany	Research Site	Riesa
Germany	Research Site	Rodgau-dudenhofen
Germany	Research Site	Schwerin
Germany	Research Site	Siegen
Germany	Research Site	Steinfurt
Germany	Research Site	Strasskirchen
Germany	Research Site	Tübingen
Germany	Research Site	Werne
Germany	Research Site	Witten
Lithuania	Research Site	Kaunas
Lithuania	Research Site	Klaipeda
Lithuania	Research Site	Panevezys
Lithuania	Research Site	Siauliai
Lithuania	Research Site	Vilnius
Netherlands	Research Site	Bennebroek
Netherlands	Research Site	Den Haag
Netherlands	Research Site	Deurne
Netherlands	Research Site	Echt
Netherlands	Research Site	Ermelo
Netherlands	Research Site	Hengelo
Netherlands	Research Site	Hoogvliet
Netherlands	Research Site	Lichtenvoorde
Netherlands	Research Site	Losser
Netherlands	Research Site	Musselkanaal
Netherlands	Research Site	Oude Pekela
Netherlands	Research Site	Rijswijk
Netherlands	Research Site	Roelofarendsveen
Netherlands	Research Site	Rotterdam
Netherlands	Research Site	s Hertogenbosch
Netherlands	Research Site	s-Gravenzande
Netherlands	Research Site	Volendam
Netherlands	Research Site	Woerden
Netherlands	Research Site	Zaandam
Poland	Research Site	Chrzanow
Poland	Research Site	Elblag
Poland	Research Site	Gdansk
Poland	Research Site	Gdynia
Poland	Research Site	Katowice
Poland	Research Site	Lodz
Poland	Research Site	Olawa
Poland	Research Site	Plock
Poland	Research Site	Poznan
Poland	Research Site	Skierniewice
Poland	Research Site	Szczecin
Sweden	Research Site	Boden
Sweden	Research Site	Gävle
Sweden	Research Site	Göteborg
Sweden	Research Site	Linköping
Sweden	Research Site	Malmö
Sweden	Research Site	Motala
Sweden	Research Site	Örebro
Sweden	Research Site	Skellefteå
Sweden	Research Site	Uppsala
Ukraine	Research Site	Chenoutsy
Ukraine	Research Site	Dnepropetrovsk
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kharkov
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Lviv
Ukraine	Research Site	Odessa
United Kingdom	Research Site	Addlestone
United Kingdom	Research Site	Ashford
United Kingdom	Research Site	Ayrshire
United Kingdom	Research Site	Burbage
United Kingdom	Research Site	Cheadle
United Kingdom	Research Site	Chesterfield
United Kingdom	Research Site	Coventry
United Kingdom	Research Site	ELY
United Kingdom	Research Site	Fife
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Harrow
United Kingdom	Research Site	Hastings
United Kingdom	Research Site	Helensburgh
United Kingdom	Research Site	Leamington Spa
United Kingdom	Research Site	Morriston
United Kingdom	Research Site	Motherwell
United Kingdom	Research Site	Newton Mearns
United Kingdom	Research Site	Northwood Middlesex
United Kingdom	Research Site	Paignton
United Kingdom	Research Site	Wokingham

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Denmark,  Estonia,  Former Serbia and Montenegro,  France,  Germany,  Lithuania,  Netherlands,  Poland,  Sweden,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change (reduction) in sitting BP (24 hours after dose)		Assessed from baseline (randomisation) to the end of the study.	No
Secondary	Proportion of patients with controlled sitting BP in each treatment group		Assessed at the end of the study	No
Secondary	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.	No

External Links

•   AstraZeneca Information - Outside of the US