Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and Placebo

Condition(s) targeted: Hypertension

Intervention: Candesartan cilexetil (Drug); Hydrochlorothiazide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Michael Klibaner, MD, Study Director, Affiliation: AstraZeneca
Istvan Edes, MD, Principal Investigator, Affiliation: DEOEC Institute of Cardiology

The aim is to compare the blood pressure lowering effect of the combination of candesartan cilexetil (candesartan) 32 mg and hydrochlorothiazide (HCT) 25 mg to that of candesartan 32 mg alone, HCT 25 mg alone and placebo in hypertensive adults.

Official title: A Double-Blind, Randomised, 4-Arm Parallel Group, Multicentre, 8-Week, Phase III Study to Assess the Antihypertensive Efficacy and Safety of the Combination of Candesartan Cilexetil (CC) 32 mg and Hydrochlorothiazide (HCT) 25 mg Compared With CC 32 mg, HCT 25 mg and Placebo in Hypertensive Adults

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Change (reduction) in sitting BP (24 hours after dose)

Secondary outcome:

Proportion of patients with controlled sitting BP in each treatment group

Occurrence of Adverse Events and discontinuation of study medication due to AEs

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

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

(substances), which the patient and the physician are willing to withdraw at enrolment and replace with placebo.

- Mean sitting DBP 90-114 mmHg (value calculated in the eCRF) at Visits 1 and 2

- Patients will be eligible for randomisation (Visit 4) if they fulfil the following

criterion:

- Mean sitting DBP of 90-114 mmHg (value calculated in the eCRF) at the end of the

4-week single-blind placebo run-in period. The run-in period should not be shorter than 4 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. Pregnancy must be excluded by a negative pregnancy test at Visit 1.

- Secondary or malignant hypertension

- Sitting SBP of 180 mmHg or more

- 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 or to any

sulphonamide derived drugs

- 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 that in the opinion of the investigator might affect the patient's participation in the study

- Chronic liver disease

- Concomitant or previous treatment with any other investigational drug within 20 days

of enrolment

- Previous enrolment in the present study

Research Site, Gozée, Belgium

Research Site, Dour, Belgium

Research Site, Marchovelette, Belgium

Research Site, Steenokkerzel, Belgium

Research Site, Linkebeek, Belgium

Research Site, Ronquières, Belgium

Research Site, Saint-Médard, Belgium

Research Site, Hasselt, Belgium

Research Site, Riga, Latvia

Research Site, Daugavpils, Latvia

Research Site, Ogre, Latvia

Research Site, Gozo, Malta

Research Site, Gwardiamangia, Malta

Research Site, Arad, Romania

Research Site, Bucuresti, Romania

Research Site, Targoviste, Romania

Research Site, Ploiesti, Romania

Research Site, Iasi, Romania

Research Site, Pitesti, Romania

Research Site, Timisoara, Romania

Research Site, Moscow, Russian Federation

Research Site, St. Petersburg, Russian Federation

Research Site, Levice, Slovakia

Research Site, Lucenec, Slovakia

Research Site, Bratislava, Slovakia

Research Site, Presov, Slovakia

Research Site, Sahy, Slovakia

AstraZeneca Clinical Trial Information - Outside US

Starting date: January 2007
Ending date: February 2008
Last updated: February 2, 2008